FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—General Hospital and Personal Use Monitoring Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Neurological Surgical Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
FPX
Strip, Adhesive, Closure, Skin
1
Product Code
FPY
Sheet, Burn
1
Product Code
KGX
Tape And Bandage, Adhesive
1
Product Code
KMF
Bandage, Liquid
1
Product Code
K
24
1916
TearRepair Liquid Skin Protectant
1
Cleared 510(K)
K
18
2733
Rochal Bioshield Silicone Film
1
Cleared 510(K)
K
17
1148
Aleo BME Liquid Bandage
1
Cleared 510(K)
K
15
3571
Cavilon Advanced High Endurance Skin Protectant
1
Cleared 510(K)
K
16
0684
Atteris No-Sting Skin Protectant
1
Cleared 510(K)
K
13
1384
KERICURE ADVANCED LIQUID BANDAGE, NATURAL SEAL LIQUID BANDAGE, LIQUID BANDAGE
1
Cleared 510(K)
K
13
3443
MARATHON NO STING LIQUID SKIN PROTECTANT
1
Cleared 510(K)
K
12
0059
LIQUID BANDAGE
1
Cleared 510(K)
K
09
2712
SKIN BARRIER FILM
1
Cleared 510(K)
K
08
3087
ECOCEL
1
Cleared 510(K)
K
08
3913
CHESSON LABS LIQUID BANDAGE
1
Cleared 510(K)
K
08
3752
GLUSEAL 90, MODEL GLU9010
1
Cleared 510(K)
K
08
2703
MRDH BANDAGE
1
Cleared 510(K)
K
08
1009
NEUTROPHASE
1
Cleared 510(K)
K
07
3663
GELSPRAY WOUND DRESSING
1
Cleared 510(K)
K
06
3202
PRODERMA LIQUID BANDAGE
1
Cleared 510(K)
K
98
4207
SILVERLON DIRECT PRESSURE WOUND DRESSING
1
Cleared 510(K)
K
06
2602
BAND-AID(R) BRAND LIQUID BANDAGE
1
Cleared 510(K)
K
05
3409
3M LIQUID BANDAGE
1
Cleared 510(K)
K
04
2955
CUTICOVER SKIN BARRIER DEVICE
1
Cleared 510(K)
K
05
0757
FLEX-AID LIQUID GEL BANDAGE AND DERMAFLEX GEL TISSUE ADHESIVE PROFESSIONAL LIQUID BANDAGE
1
Cleared 510(K)
K
05
1082
MEDTRADE PRODUCTS SKIN PROTECTIVE BARRIER WIPE (STERILE AND PRESERVED)
1
Cleared 510(K)
K
03
2948
ELASTIC SKIN LIQUID BANDAGE
1
Cleared 510(K)
K
04
0779
RESTORE WOUND CLEANSER
1
Cleared 510(K)
K
03
1321
LIQUISHIELD LIQUID BANDAGE, MODEL LSB 0001
1
Cleared 510(K)
K
03
1263
3M LIQUID BANDAGE, MODEL 120-LB
1
Cleared 510(K)
K
03
0574
GLUSEAL 5ML DISPENSER, 1 ML DISPENSER, .2 ML DISPENSER
1
Cleared 510(K)
K
02
3163
LIQUISHIELD-S (0.7G), MODEL LS 0010, LIQUISHIELD-S (2.0G), MODEL LS 0020
1
Cleared 510(K)
K
02
2645
CURAD
1
Cleared 510(K)
K
01
3225
INSTACLOT FOR OTC USE, TRAUMASSTAT FOR PRESCRIPTION USE
1
Cleared 510(K)
K
00
2338
LIQUIDERM LIQUID ADHESIVE BANDAGE
1
Cleared 510(K)
K
00
2550
RDH BANDAGE
1
Cleared 510(K)
K
99
1729
FERRIS POLYOSTOMY STERILE WOUND DRESSING
1
Cleared 510(K)
K
99
2032
ACRY ISLAND BORDER DRESSING, MODELS 2031, 2032, 2033
1
Cleared 510(K)
K
99
1920
DERMAPHYLYX HYDROPHILIC FOAM WOUND DRESSING
1
Cleared 510(K)
K
99
1933
DERMAPHYLYX FOAM ISLAND DRESSING
1
Cleared 510(K)
K
99
1609
DERMAPHYLYX SUPER ABSORBENT FIBER DRESSING
1
Cleared 510(K)
K
99
1608
DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING
1
Cleared 510(K)
K
99
1694
DYNAREX DRAIN SPONGE
1
Cleared 510(K)
K
99
1695
DYNAREX NON-WOVEN SPONGE
1
Cleared 510(K)
K
99
0955
MODIFICATION OF:BIODERM FOAM WOUND DRESSING
1
Cleared 510(K)
K
99
0906
FERRIS POLYMEM POLYWIC STERILE CAVITY WOUND FILLER
1
Cleared 510(K)
K
98
4539
FERRIS POLYMEM CALCIUM ALGINATE STERILE WOUND DRESSING
1
Cleared 510(K)
K
97
3227
ASKINA HYDROCOLLOID/THIN
1
Cleared 510(K)
K
98
3519
COMFEEL SEASORB DRESSING
1
Cleared 510(K)
K
98
4177
MODIFICATION TO SKVEKPATCH
1
Cleared 510(K)
K
98
0117
NUVO BARRIER FILM
1
Cleared 510(K)
K
98
3833
ACTICOAT COMPOSITE WOUND DRESSING, ACTICOAT COMPOSITE WOUND DRESSING-ADHESIVE
1
Cleared 510(K)
K
98
3210
ALGISITE M
1
Cleared 510(K)
K
98
3554
ALLDRESS, ABSORBENT FILM DRESSING
1
Cleared 510(K)
K
98
2893
3M TEGASORB HYDROCOLLOID DRESSING
1
Cleared 510(K)
K
98
2892
3M TEGASORB THIN HYDROCOLLOID DRESSING
1
Cleared 510(K)
K
98
2818
HOSPAL TIPSTOP
1
Cleared 510(K)
K
98
2778
BIODERM FOAM WOUND DRESSING
1
Cleared 510(K)
K
98
2234
AL-GEN CALCIUM ALGINATE DRESSING
1
Cleared 510(K)
K
98
2116
AQUACEL HYDROFIBER WOUND DRESSING
1
Cleared 510(K)
K
98
0779
THALAFIX NATURAL SEA SALT DRESSING
1
Cleared 510(K)
K
98
0989
3M TEGAGEN HI ALGINATE DRESSING & 3M TEGAGEN HG ALGINATE DRESSING
1
Cleared 510(K)
K
98
0673
SPYROSORB FOAM ISLAND WOUND DRESSING
1
Cleared 510(K)
K
98
0863
DUMEX PAK-ITS NON-WOVEN DRESSING IMPREGNATED SITH SODIUM CHLORIDE (HYPERTONIC)
1
Cleared 510(K)
K
98
0720
NONWOVEN PAD
1
Cleared 510(K)
K
98
0451
BIODERM CALCIUM ALGINATE DRESSING
1
Cleared 510(K)
K
97
1612
OSMO/PCA PILLOW WOUND DRESSING
1
Cleared 510(K)
K
98
0382
NON-WOVEN COMPRESS
1
Cleared 510(K)
K
97
4823
NONWOVEN DRESSING
1
Cleared 510(K)
K
97
4205
KNITTED WOUND DRESSING-STANDARD, WCL AND RIBBON
1
Cleared 510(K)
K
97
3619
KENDALL CURITY NON-ADHERING DRESSING
1
Cleared 510(K)
K
97
2329
OSMOCYTE RA WOUND DRESSING
1
Cleared 510(K)
K
97
2150
OSMOCYTE ISLAND WOUND DRESSING
1
Cleared 510(K)
K
97
3509
KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSING
1
Cleared 510(K)
K
97
3429
BIODERM FOAM WOUND DRESSING
1
Cleared 510(K)
K
97
3228
STING SKIN PREP WIPE(59420600)/STING SKIN PREP SWAB (59420700)
1
Cleared 510(K)
K
97
3283
ALGINATE/ZINC WOUND DRESSING
1
Cleared 510(K)
K
97
2530
CONVATEC ODOR CONTROL WOUND DRESSING
1
Cleared 510(K)
K
97
1091
OPPURTUNITY TRACHEOSTOMY CARE KIT
1
Cleared 510(K)
K
97
1090
OPPORTUNITY DRESSING CHANGE TRAY
1
Cleared 510(K)
K
97
2062
CONVATEC NON-ADHESIVE DRESSING
1
Cleared 510(K)
K
97
0660
DERMAGRAN WOUND MANAGEMENT SYSTEM
1
Cleared 510(K)
K
97
2336
DERMAMEND HYDROGEL GAUZE DRESSING
1
Cleared 510(K)
K
97
1337
EPITECH ISLAND DRESSINGS
1
Cleared 510(K)
K
97
0600
DERMAMEND FOAM ISLAND DRESSING
1
Cleared 510(K)
K
96
5120
ALLCLENZ WOUND CLEANSER
1
Cleared 510(K)
K
96
4231
NASP HYDROCOLLOID DRESSING (REGULAR OR THIN)
1
Cleared 510(K)
K
96
4614
ULTRAFERA WOUND DRESSING
1
Cleared 510(K)
K
96
4016
TIELLE HYDROPOLYMER FOAM DRESSING
1
Cleared 510(K)
K
96
3598
INNOVATIVE TECHNOLOGIES ALIGINATE/PECTIN WOUND DRESSINGS
1
Cleared 510(K)
K
96
3603
DERMAGRAN HYDROPHILIC OINTMENT
1
Cleared 510(K)
K
96
2623
OSMOCYTE ULTRA/PE PILLOW WOUND DRESSING
1
Cleared 510(K)
K
96
3656
FOAM CALCIUM ALIGINATE TOPICAL WOUND DRESSING
1
Cleared 510(K)
K
96
3602
BIODERM PVP FOAM WOUND DRESSING
1
Cleared 510(K)
K
96
3096
ALLEVYN HYDRO POLY DRESSING ND ALL TRAC DRESSING
1
Cleared 510(K)
K
95
4728
PROD NO. 01-1694 - 4X4 FOAM DRESSING
1
Cleared 510(K)
K
96
2740
DERMISTICK SEPP APPLICATOR(200 CT)/(40 CT) 260640/260641
1
Cleared 510(K)
K
96
2421
SORBCEL ALGINATE/CMC WOUND DRESSING
1
Cleared 510(K)
K
96
1323
LYOFOAM EXTRA C ODOR ABSORBING WOUND DRESSING
1
Cleared 510(K)
K
96
1662
ADVANCED CARE HYDROPHILIC WOUND DRESSINGS
1
Cleared 510(K)
K
96
1452
LYOFOAM EXTRA 'A' STERILE ADHESIVE WOUND DRESSING
1
Cleared 510(K)
K
95
5453
ACTICOAT SILVER COATED DRESSING
1
Cleared 510(K)
K
95
5399
MULTIDEX PLUS HYDROPHILIC WOUND DRESSING
1
Cleared 510(K)
K
95
5103
3M NO STING BARRIER FILM
1
Cleared 510(K)
K
95
3500
HEMO-BARRIER
1
Cleared 510(K)
K
95
4275
MEPORE PLUS (9X15CM)
1
Cleared 510(K)
K
95
4918
COMBIDERM ACD
1
Cleared 510(K)
K
95
0621
BIOFILL BIOCELLULOSE DRESSING STERILE
1
Cleared 510(K)
K
95
4274
MEPORE (6X7)
1
Cleared 510(K)
K
95
4919
MEROCEL SOFT WOUND DRESSING
1
Cleared 510(K)
K
95
4857
COMFEEL:ALGINATE FILLER
1
Cleared 510(K)
K
95
2565
LYOFOAM EXTRA
1
Cleared 510(K)
K
95
4230
SORBSAN PLUS TOPICAL WOUND DRESSING
1
Cleared 510(K)
K
95
3403
DEROYAL INDUSTRIES, INC. POLYDERM & POLYDERM BORDER FOAM WOUND DRESSINGS
1
Cleared 510(K)
K
95
3497
COMFEEL:ALGINATE DRESSING
1
Cleared 510(K)
K
95
3019
HYDROPHILIC FOAM DRESSING
1
Cleared 510(K)
K
95
3131
EXUSORB STERILE ABSORBENT
1
Cleared 510(K)
K
95
3070
WOUNDFOAM 4 X 4
1
Cleared 510(K)
K
95
3781
INNOVATIVE TECHNOLOGIES CALCIUM ALGINATE WOUND DRESSINGS
1
Cleared 510(K)
K
95
1561
DYNASORB
1
Cleared 510(K)
K
95
2547
COVERSAN, ISLESAN
1
Cleared 510(K)
K
95
2526
CUTINOVA CAVITY
1
Cleared 510(K)
K
95
2420
STERIGAUZE WET DRESSING
1
Cleared 510(K)
K
95
1909
RYNEL MEDICAL FOAM
1
Cleared 510(K)
K
95
1730
SPYROFOAM WOUND DRESSING
1
Cleared 510(K)
K
95
0685
BIODERM MEDICAL HYDROCOLLOID WOUND DRESSING
1
Cleared 510(K)
K
95
1914
HYDRACARE ABSORBENT WOUND DRESSING
1
Cleared 510(K)
K
95
1327
COMFEEL PLUS CONTOUR DRESSING
1
Cleared 510(K)
K
95
0619
BIODERM MEDICAL FOAM WOUND DRESSING
1
Cleared 510(K)
K
95
1499
DERMAGRAN HYDROPHILIC OINTMENT
1
Cleared 510(K)
K
94
6245
TIELLE* HYDROPOLYMER DRESSING
1
Cleared 510(K)
K
95
0775
CURASORB ZN ALGINATE WOUND DRESSING
1
Cleared 510(K)
K
94
5224
GRX FOAM DRESSING
1
Cleared 510(K)
K
94
5802
DERMAGRAN WOUND CLEANSER WITH ZINC
1
Cleared 510(K)
K
94
5330
ALLEVYN ADHESIVE
1
Cleared 510(K)
K
94
6269
CURAFOAM ANDD CURAFOAM PLUS HYDROPHILIC POLYURETHANE FOAM DRESSINGS
1
Cleared 510(K)
K
94
5206
ALLDRESS MULTI LAYERED WOUND DRESSING
1
Cleared 510(K)
K
94
4581
CUTINOVA THIN WOUND DRESSING
1
Cleared 510(K)
K
94
4468
KERLIX ZINC SALINE DRESSING
1
Cleared 510(K)
K
94
4491
DERMAGRAN HYDROPHILIC OINTMENT
1
Cleared 510(K)
K
94
5000
MULTIDEX HYDROPHILIC WOUND DRESSING
1
Cleared 510(K)
K
94
3781
ACRYDERM ADVANCED WOUND DRESSING
1
Cleared 510(K)
K
94
3636
CURADERM ALGINATE HYDROCOLLOID
1
Cleared 510(K)
K
94
1688
INNOVATIVE TECHNOLOGIES HYDROCOLLOID WOUND DRESSINGS
1
Cleared 510(K)
K
94
3619
CAVI-CARE CONFORMING FOAM DRESSING
1
Cleared 510(K)
K
94
3258
HYDROCOLLOID WOUND DRESSING
1
Cleared 510(K)
K
94
2270
SAF-GEL HYDRATING DERMAL WOUND DRESSING
1
Cleared 510(K)
K
94
3364
CORASSIST WOUND DRESSING
1
Cleared 510(K)
K
94
2283
COMFEEL PLUS TRANSPARENT DRESSING
1
Cleared 510(K)
K
94
1176
ALGINATE FIBER
1
Cleared 510(K)
K
94
2815
HYDROSKIN WOUND DRESSING
1
Cleared 510(K)
K
94
1999
HYPERTONIC SALINE WET DRESSING - STERILE
1
Cleared 510(K)
K
94
2459
CURASALT HYPERTONIC SALINE DRESSING
1
Cleared 510(K)
K
94
0572
MEROCEL(R) WOUND DRESSING (WITH HEMOSTATIC CLAIM)
1
Cleared 510(K)
K
93
2913
FERRIS POLYMEM HYDROPHILIC WOUND DRESSING
1
Cleared 510(K)
K
94
1216
HYDRODERM EXTRA THIN INTELLIGENT HYDROCOLLIOID DRESSING
1
Cleared 510(K)
K
94
1263
COMFEEL PLUS WOUND DRESSING
1
Cleared 510(K)
K
94
0738
KTI HY-Q(TM) WOUND DRESSING
1
Cleared 510(K)
K
94
0624
3M TEGASORB HYDROCOLLOID DRESSING
1
Cleared 510(K)
K
94
0404
ALGINATE FIBER TOPICAL WOUND DRESSING
1
Cleared 510(K)
K
94
0414
IODOFLEX PASTE
1
Cleared 510(K)
K
94
0407
KALTOGEL WOUND DRESSING
1
Cleared 510(K)
K
93
6193
COMB-18 WOUND DRESSING
1
Cleared 510(K)
K
93
6052
BRADY MEDICAL PRODUCTS HYSORB(TM) WOUND DRESSING
1
Cleared 510(K)
K
93
5783
MITRAFLEX CAVITY WOUND DRESSING
1
Cleared 510(K)
K
92
3516
COMPOUND BENZOIN TINCTURE USP SEPP
1
Cleared 510(K)
K
92
0399
COMPOUND BENZOIN TINCTURE USP FREPP
1
Cleared 510(K)
K
92
3299
APLICARE ONE COMPUND BENZION TINCTURE SWABSTICK
1
Cleared 510(K)
K
92
5004
ALLKARE BARRIER WIPE
1
Cleared 510(K)
K
93
5060
BRENNEN MEDICAL STERILE SALINE SOLUTION
1
Cleared 510(K)
K
92
6230
EPIDRESS & DERMASORB HYDROCOLLOID ALGINATE DRESSIN
1
Cleared 510(K)
K
93
4839
MESALT STERILE DRESSING
1
Cleared 510(K)
K
93
0632
CHEMOSITE IMPLANTABLE DRUG DELIVERY
1
Cleared 510(K)
K
93
3689
MODIFICATION OF KENDALL CURASORB CALCIUM ALGINATE WOUND DRESSING
1
Cleared 510(K)
K
92
5991
DUODERM CGF CONTROL GEL FORMULA DRESSING & BORDER
1
Cleared 510(K)
K
92
5993
DUODERM HYDROACTIVE DRESSING
1
Cleared 510(K)
K
92
5990
DUODERM EXTRA THIN CGF DRESSING
1
Cleared 510(K)
K
92
5937
WELLS LAMONT HANDAGES/MED WRAP DRESSINGS
1
Cleared 510(K)
K
93
1565
MEROCEL WOUND DRESSING
1
Cleared 510(K)
K
93
0468
3M INCONTINENCE BARRIER FILM, PRODUCT SERIES 336X
1
Cleared 510(K)
K
92
6380
ALTA DRESSING FRAME
1
Cleared 510(K)
K
92
4280
3M TEGASORB THIN HYDROCOLLOID DRESSING
1
Cleared 510(K)
K
92
3957
NASAL CAVITY WOUND DRESSING
1
Cleared 510(K)
K
92
6044
MPM WET DRESSING (SALINE)
1
Cleared 510(K)
K
92
5376
COMFEEL(R) WOUND DRESSING SD
1
Cleared 510(K)
K
92
5001
CURITY CALCIUM ALGINATE WOUND DRESSING
1
Cleared 510(K)
K
92
2760
ATRAUM WOUND DRESSING--MODIFICATION
1
Cleared 510(K)
K
92
1502
HYSORB WOUND DRESSING
1
Cleared 510(K)
K
92
2681
CUTINOVA FOAM
1
Cleared 510(K)
K
92
2540
WOUND DRESSING
1
Cleared 510(K)
K
92
2461
COMFEEL WOUND DRESSING ORD
1
Cleared 510(K)
K
92
2466
COMFEEL WOUND DRESSING SD
1
Cleared 510(K)
K
92
0794
BRND SKIN PROTECTION PREP SERIES 33XX
1
Cleared 510(K)
K
92
1009
KALTOSTAT FORTEX WOUND DRESSING
1
Cleared 510(K)
K
92
0925
COMFEEL CONTOUR DRESSING
1
Cleared 510(K)
K
92
0367
ULCUFLEX HYDROCULLOID DRESSING
1
Cleared 510(K)
K
92
0368
ULCUFLEX HYDROCOLLOID PASTE
1
Cleared 510(K)
K
92
0366
ULCUFLEX HYDROCOLOID POWDER
1
Cleared 510(K)
K
91
2506
CRITIC-AID WOUND DRESSING
1
Cleared 510(K)
K
91
4147
ALLEVLYN WOUND DRESSING, MODIFICATION
1
Cleared 510(K)
K
91
4314
FORTEX(TM) WOUND DRESSING
1
Cleared 510(K)
K
91
0927
SPENCIO SKIN GUARD KIT
1
Cleared 510(K)
K
90
5439
HYPERGEL PROTECTIVE WOUND GEL
1
Cleared 510(K)
K
90
4411
INTRASITE GEL (LABELING REVISION)
1
Cleared 510(K)
K
89
5764
MODIFIED LYOFOAM WOUND DRESSINGS
1
Cleared 510(K)
K
90
1877
ALLEVYN DRESSING (LABELING REVISED)
1
Cleared 510(K)
K
90
1878
INTRASITE GEL (LABELING REVISION)
1
Cleared 510(K)
K
90
0127
FERRIS HYDROPHILIC DRESSING (ADD'L INDICATIONS)
1
Cleared 510(K)
K
90
1155
DUODERM* CONTROL GEL FORMULA BORDER DRESSING
1
Cleared 510(K)
K
89
6531
NOVADERM
1
Cleared 510(K)
K
89
5819
MODIFIED LABELING TO THE SPAND-GEL GRANULATED GEL
1
Cleared 510(K)
K
89
5606
EXUSORB(TM) GEL DRESSING
1
Cleared 510(K)
K
86
4124
SPAND-GEL GRANULATED GEL
1
Cleared 510(K)
K
84
3300
SKIN-LITE
1
Cleared 510(K)
K
82
0134
VIGILON PRIMARY WOUND DRESSING, STERILE
1
Cleared 510(K)
K
81
1625
PREP-SITE PROTECTIVE DRESSING WIPE
1
Cleared 510(K)
K
81
1446
HYDRON WOUND DRESSING KIT
1
Cleared 510(K)
K
81
0240
CLINIGUARD STERILE
1
Cleared 510(K)
K
80
0527
CLINIGUARD
1
Cleared 510(K)
K
79
1865
HYDRON BURN DRESSING FIELD KIT
1
Cleared 510(K)
K
78
2008
DRESSING, ENVIRON WOUND
1
Cleared 510(K)
K
79
0384
KIMLON BEDGARD UNDERPAD
1
Cleared 510(K)
K
78
1877
UNDERPADS, HIGH ABSORBANT POLYMER
1
Cleared 510(K)
K
78
1406
HYDRON BURN BANDAGE MANUAL APPLICATION
1
Cleared 510(K)
K
78
1031
AEROPLAST DRESSING
1
Cleared 510(K)
K
78
0616
HYDRON BURN DISPOSABLE DISPENSER SET
1
Cleared 510(K)
K
77
1321
HYDRON BURN BANDAGE
1
Cleared 510(K)
LRS
I.V. Start Kit
2
Product Code
MCY
Wound Dressing Kit
2
Product Code
MHW
Dressing, Compression
1
Product Code
NEC
Bandage, Liquid, Skin Protectant
1
Product Code
OXQ
Dressing Change Tray
1
Product Code
PYO
Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use
1
Product Code
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 30 November 2024 at 11:09 am
SU
/
subpart-f—general-hospital-and-personal-use-therapeutic-devices
/
KMF
/
K914147
View Source
ALLEVLYN WOUND DRESSING, MODIFICATION
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K914147
510(k) Type
Traditional
Applicant
SMITH & NEPHEW UNITED, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/3/1992
Days to Decision
140 days
Submission Type
Statement
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Miscellaneous
Subpart B—Diagnostic Devices
Subpart C—General Hospital and Personal Use Monitoring Devices
Subpart D—Prosthetic Devices
Subpart E—Neurological Surgical Devices
Subpart E—Surgical Devices
Subpart F—General Hospital and Personal Use Therapeutic Devices
FPX
Strip, Adhesive, Closure, Skin
FPY
Sheet, Burn
KGX
Tape And Bandage, Adhesive
KMF
Bandage, Liquid
K
24
1916
TearRepair Liquid Skin Protectant
K
18
2733
Rochal Bioshield Silicone Film
K
17
1148
Aleo BME Liquid Bandage
K
15
3571
Cavilon Advanced High Endurance Skin Protectant
K
16
0684
Atteris No-Sting Skin Protectant
K
13
1384
KERICURE ADVANCED LIQUID BANDAGE, NATURAL SEAL LIQUID BANDAGE, LIQUID BANDAGE
K
13
3443
MARATHON NO STING LIQUID SKIN PROTECTANT
K
12
0059
LIQUID BANDAGE
K
09
2712
SKIN BARRIER FILM
K
08
3087
ECOCEL
K
08
3913
CHESSON LABS LIQUID BANDAGE
K
08
3752
GLUSEAL 90, MODEL GLU9010
K
08
2703
MRDH BANDAGE
K
08
1009
NEUTROPHASE
K
07
3663
GELSPRAY WOUND DRESSING
K
06
3202
PRODERMA LIQUID BANDAGE
K
98
4207
SILVERLON DIRECT PRESSURE WOUND DRESSING
K
06
2602
BAND-AID(R) BRAND LIQUID BANDAGE
K
05
3409
3M LIQUID BANDAGE
K
04
2955
CUTICOVER SKIN BARRIER DEVICE
K
05
0757
FLEX-AID LIQUID GEL BANDAGE AND DERMAFLEX GEL TISSUE ADHESIVE PROFESSIONAL LIQUID BANDAGE
K
05
1082
MEDTRADE PRODUCTS SKIN PROTECTIVE BARRIER WIPE (STERILE AND PRESERVED)
K
03
2948
ELASTIC SKIN LIQUID BANDAGE
K
04
0779
RESTORE WOUND CLEANSER
K
03
1321
LIQUISHIELD LIQUID BANDAGE, MODEL LSB 0001
K
03
1263
3M LIQUID BANDAGE, MODEL 120-LB
K
03
0574
GLUSEAL 5ML DISPENSER, 1 ML DISPENSER, .2 ML DISPENSER
K
02
3163
LIQUISHIELD-S (0.7G), MODEL LS 0010, LIQUISHIELD-S (2.0G), MODEL LS 0020
K
02
2645
CURAD
K
01
3225
INSTACLOT FOR OTC USE, TRAUMASSTAT FOR PRESCRIPTION USE
K
00
2338
LIQUIDERM LIQUID ADHESIVE BANDAGE
K
00
2550
RDH BANDAGE
K
99
1729
FERRIS POLYOSTOMY STERILE WOUND DRESSING
K
99
2032
ACRY ISLAND BORDER DRESSING, MODELS 2031, 2032, 2033
K
99
1920
DERMAPHYLYX HYDROPHILIC FOAM WOUND DRESSING
K
99
1933
DERMAPHYLYX FOAM ISLAND DRESSING
K
99
1609
DERMAPHYLYX SUPER ABSORBENT FIBER DRESSING
K
99
1608
DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING
K
99
1694
DYNAREX DRAIN SPONGE
K
99
1695
DYNAREX NON-WOVEN SPONGE
K
99
0955
MODIFICATION OF:BIODERM FOAM WOUND DRESSING
K
99
0906
FERRIS POLYMEM POLYWIC STERILE CAVITY WOUND FILLER
K
98
4539
FERRIS POLYMEM CALCIUM ALGINATE STERILE WOUND DRESSING
K
97
3227
ASKINA HYDROCOLLOID/THIN
K
98
3519
COMFEEL SEASORB DRESSING
K
98
4177
MODIFICATION TO SKVEKPATCH
K
98
0117
NUVO BARRIER FILM
K
98
3833
ACTICOAT COMPOSITE WOUND DRESSING, ACTICOAT COMPOSITE WOUND DRESSING-ADHESIVE
K
98
3210
ALGISITE M
K
98
3554
ALLDRESS, ABSORBENT FILM DRESSING
K
98
2893
3M TEGASORB HYDROCOLLOID DRESSING
K
98
2892
3M TEGASORB THIN HYDROCOLLOID DRESSING
K
98
2818
HOSPAL TIPSTOP
K
98
2778
BIODERM FOAM WOUND DRESSING
K
98
2234
AL-GEN CALCIUM ALGINATE DRESSING
K
98
2116
AQUACEL HYDROFIBER WOUND DRESSING
K
98
0779
THALAFIX NATURAL SEA SALT DRESSING
K
98
0989
3M TEGAGEN HI ALGINATE DRESSING & 3M TEGAGEN HG ALGINATE DRESSING
K
98
0673
SPYROSORB FOAM ISLAND WOUND DRESSING
K
98
0863
DUMEX PAK-ITS NON-WOVEN DRESSING IMPREGNATED SITH SODIUM CHLORIDE (HYPERTONIC)
K
98
0720
NONWOVEN PAD
K
98
0451
BIODERM CALCIUM ALGINATE DRESSING
K
97
1612
OSMO/PCA PILLOW WOUND DRESSING
K
98
0382
NON-WOVEN COMPRESS
K
97
4823
NONWOVEN DRESSING
K
97
4205
KNITTED WOUND DRESSING-STANDARD, WCL AND RIBBON
K
97
3619
KENDALL CURITY NON-ADHERING DRESSING
K
97
2329
OSMOCYTE RA WOUND DRESSING
K
97
2150
OSMOCYTE ISLAND WOUND DRESSING
K
97
3509
KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSING
K
97
3429
BIODERM FOAM WOUND DRESSING
K
97
3228
STING SKIN PREP WIPE(59420600)/STING SKIN PREP SWAB (59420700)
K
97
3283
ALGINATE/ZINC WOUND DRESSING
K
97
2530
CONVATEC ODOR CONTROL WOUND DRESSING
K
97
1091
OPPURTUNITY TRACHEOSTOMY CARE KIT
K
97
1090
OPPORTUNITY DRESSING CHANGE TRAY
K
97
2062
CONVATEC NON-ADHESIVE DRESSING
K
97
0660
DERMAGRAN WOUND MANAGEMENT SYSTEM
K
97
2336
DERMAMEND HYDROGEL GAUZE DRESSING
K
97
1337
EPITECH ISLAND DRESSINGS
K
97
0600
DERMAMEND FOAM ISLAND DRESSING
K
96
5120
ALLCLENZ WOUND CLEANSER
K
96
4231
NASP HYDROCOLLOID DRESSING (REGULAR OR THIN)
K
96
4614
ULTRAFERA WOUND DRESSING
K
96
4016
TIELLE HYDROPOLYMER FOAM DRESSING
K
96
3598
INNOVATIVE TECHNOLOGIES ALIGINATE/PECTIN WOUND DRESSINGS
K
96
3603
DERMAGRAN HYDROPHILIC OINTMENT
K
96
2623
OSMOCYTE ULTRA/PE PILLOW WOUND DRESSING
K
96
3656
FOAM CALCIUM ALIGINATE TOPICAL WOUND DRESSING
K
96
3602
BIODERM PVP FOAM WOUND DRESSING
K
96
3096
ALLEVYN HYDRO POLY DRESSING ND ALL TRAC DRESSING
K
95
4728
PROD NO. 01-1694 - 4X4 FOAM DRESSING
K
96
2740
DERMISTICK SEPP APPLICATOR(200 CT)/(40 CT) 260640/260641
K
96
2421
SORBCEL ALGINATE/CMC WOUND DRESSING
K
96
1323
LYOFOAM EXTRA C ODOR ABSORBING WOUND DRESSING
K
96
1662
ADVANCED CARE HYDROPHILIC WOUND DRESSINGS
K
96
1452
LYOFOAM EXTRA 'A' STERILE ADHESIVE WOUND DRESSING
K
95
5453
ACTICOAT SILVER COATED DRESSING
K
95
5399
MULTIDEX PLUS HYDROPHILIC WOUND DRESSING
K
95
5103
3M NO STING BARRIER FILM
K
95
3500
HEMO-BARRIER
K
95
4275
MEPORE PLUS (9X15CM)
K
95
4918
COMBIDERM ACD
K
95
0621
BIOFILL BIOCELLULOSE DRESSING STERILE
K
95
4274
MEPORE (6X7)
K
95
4919
MEROCEL SOFT WOUND DRESSING
K
95
4857
COMFEEL:ALGINATE FILLER
K
95
2565
LYOFOAM EXTRA
K
95
4230
SORBSAN PLUS TOPICAL WOUND DRESSING
K
95
3403
DEROYAL INDUSTRIES, INC. POLYDERM & POLYDERM BORDER FOAM WOUND DRESSINGS
K
95
3497
COMFEEL:ALGINATE DRESSING
K
95
3019
HYDROPHILIC FOAM DRESSING
K
95
3131
EXUSORB STERILE ABSORBENT
K
95
3070
WOUNDFOAM 4 X 4
K
95
3781
INNOVATIVE TECHNOLOGIES CALCIUM ALGINATE WOUND DRESSINGS
K
95
1561
DYNASORB
K
95
2547
COVERSAN, ISLESAN
K
95
2526
CUTINOVA CAVITY
K
95
2420
STERIGAUZE WET DRESSING
K
95
1909
RYNEL MEDICAL FOAM
K
95
1730
SPYROFOAM WOUND DRESSING
K
95
0685
BIODERM MEDICAL HYDROCOLLOID WOUND DRESSING
K
95
1914
HYDRACARE ABSORBENT WOUND DRESSING
K
95
1327
COMFEEL PLUS CONTOUR DRESSING
K
95
0619
BIODERM MEDICAL FOAM WOUND DRESSING
K
95
1499
DERMAGRAN HYDROPHILIC OINTMENT
K
94
6245
TIELLE* HYDROPOLYMER DRESSING
K
95
0775
CURASORB ZN ALGINATE WOUND DRESSING
K
94
5224
GRX FOAM DRESSING
K
94
5802
DERMAGRAN WOUND CLEANSER WITH ZINC
K
94
5330
ALLEVYN ADHESIVE
K
94
6269
CURAFOAM ANDD CURAFOAM PLUS HYDROPHILIC POLYURETHANE FOAM DRESSINGS
K
94
5206
ALLDRESS MULTI LAYERED WOUND DRESSING
K
94
4581
CUTINOVA THIN WOUND DRESSING
K
94
4468
KERLIX ZINC SALINE DRESSING
K
94
4491
DERMAGRAN HYDROPHILIC OINTMENT
K
94
5000
MULTIDEX HYDROPHILIC WOUND DRESSING
K
94
3781
ACRYDERM ADVANCED WOUND DRESSING
K
94
3636
CURADERM ALGINATE HYDROCOLLOID
K
94
1688
INNOVATIVE TECHNOLOGIES HYDROCOLLOID WOUND DRESSINGS
K
94
3619
CAVI-CARE CONFORMING FOAM DRESSING
K
94
3258
HYDROCOLLOID WOUND DRESSING
K
94
2270
SAF-GEL HYDRATING DERMAL WOUND DRESSING
K
94
3364
CORASSIST WOUND DRESSING
K
94
2283
COMFEEL PLUS TRANSPARENT DRESSING
K
94
1176
ALGINATE FIBER
K
94
2815
HYDROSKIN WOUND DRESSING
K
94
1999
HYPERTONIC SALINE WET DRESSING - STERILE
K
94
2459
CURASALT HYPERTONIC SALINE DRESSING
K
94
0572
MEROCEL(R) WOUND DRESSING (WITH HEMOSTATIC CLAIM)
K
93
2913
FERRIS POLYMEM HYDROPHILIC WOUND DRESSING
K
94
1216
HYDRODERM EXTRA THIN INTELLIGENT HYDROCOLLIOID DRESSING
K
94
1263
COMFEEL PLUS WOUND DRESSING
K
94
0738
KTI HY-Q(TM) WOUND DRESSING
K
94
0624
3M TEGASORB HYDROCOLLOID DRESSING
K
94
0404
ALGINATE FIBER TOPICAL WOUND DRESSING
K
94
0414
IODOFLEX PASTE
K
94
0407
KALTOGEL WOUND DRESSING
K
93
6193
COMB-18 WOUND DRESSING
K
93
6052
BRADY MEDICAL PRODUCTS HYSORB(TM) WOUND DRESSING
K
93
5783
MITRAFLEX CAVITY WOUND DRESSING
K
92
3516
COMPOUND BENZOIN TINCTURE USP SEPP
K
92
0399
COMPOUND BENZOIN TINCTURE USP FREPP
K
92
3299
APLICARE ONE COMPUND BENZION TINCTURE SWABSTICK
K
92
5004
ALLKARE BARRIER WIPE
K
93
5060
BRENNEN MEDICAL STERILE SALINE SOLUTION
K
92
6230
EPIDRESS & DERMASORB HYDROCOLLOID ALGINATE DRESSIN
K
93
4839
MESALT STERILE DRESSING
K
93
0632
CHEMOSITE IMPLANTABLE DRUG DELIVERY
K
93
3689
MODIFICATION OF KENDALL CURASORB CALCIUM ALGINATE WOUND DRESSING
K
92
5991
DUODERM CGF CONTROL GEL FORMULA DRESSING & BORDER
K
92
5993
DUODERM HYDROACTIVE DRESSING
K
92
5990
DUODERM EXTRA THIN CGF DRESSING
K
92
5937
WELLS LAMONT HANDAGES/MED WRAP DRESSINGS
K
93
1565
MEROCEL WOUND DRESSING
K
93
0468
3M INCONTINENCE BARRIER FILM, PRODUCT SERIES 336X
K
92
6380
ALTA DRESSING FRAME
K
92
4280
3M TEGASORB THIN HYDROCOLLOID DRESSING
K
92
3957
NASAL CAVITY WOUND DRESSING
K
92
6044
MPM WET DRESSING (SALINE)
K
92
5376
COMFEEL(R) WOUND DRESSING SD
K
92
5001
CURITY CALCIUM ALGINATE WOUND DRESSING
K
92
2760
ATRAUM WOUND DRESSING--MODIFICATION
K
92
1502
HYSORB WOUND DRESSING
K
92
2681
CUTINOVA FOAM
K
92
2540
WOUND DRESSING
K
92
2461
COMFEEL WOUND DRESSING ORD
K
92
2466
COMFEEL WOUND DRESSING SD
K
92
0794
BRND SKIN PROTECTION PREP SERIES 33XX
K
92
1009
KALTOSTAT FORTEX WOUND DRESSING
K
92
0925
COMFEEL CONTOUR DRESSING
K
92
0367
ULCUFLEX HYDROCULLOID DRESSING
K
92
0368
ULCUFLEX HYDROCOLLOID PASTE
K
92
0366
ULCUFLEX HYDROCOLOID POWDER
K
91
2506
CRITIC-AID WOUND DRESSING
K
91
4147
ALLEVLYN WOUND DRESSING, MODIFICATION
K
91
4314
FORTEX(TM) WOUND DRESSING
K
91
0927
SPENCIO SKIN GUARD KIT
K
90
5439
HYPERGEL PROTECTIVE WOUND GEL
K
90
4411
INTRASITE GEL (LABELING REVISION)
K
89
5764
MODIFIED LYOFOAM WOUND DRESSINGS
K
90
1877
ALLEVYN DRESSING (LABELING REVISED)
K
90
1878
INTRASITE GEL (LABELING REVISION)
K
90
0127
FERRIS HYDROPHILIC DRESSING (ADD'L INDICATIONS)
K
90
1155
DUODERM* CONTROL GEL FORMULA BORDER DRESSING
K
89
6531
NOVADERM
K
89
5819
MODIFIED LABELING TO THE SPAND-GEL GRANULATED GEL
K
89
5606
EXUSORB(TM) GEL DRESSING
K
86
4124
SPAND-GEL GRANULATED GEL
K
84
3300
SKIN-LITE
K
82
0134
VIGILON PRIMARY WOUND DRESSING, STERILE
K
81
1625
PREP-SITE PROTECTIVE DRESSING WIPE
K
81
1446
HYDRON WOUND DRESSING KIT
K
81
0240
CLINIGUARD STERILE
K
80
0527
CLINIGUARD
K
79
1865
HYDRON BURN DRESSING FIELD KIT
K
78
2008
DRESSING, ENVIRON WOUND
K
79
0384
KIMLON BEDGARD UNDERPAD
K
78
1877
UNDERPADS, HIGH ABSORBANT POLYMER
K
78
1406
HYDRON BURN BANDAGE MANUAL APPLICATION
K
78
1031
AEROPLAST DRESSING
K
78
0616
HYDRON BURN DISPOSABLE DISPENSER SET
K
77
1321
HYDRON BURN BANDAGE
LRS
I.V. Start Kit
MCY
Wound Dressing Kit
MHW
Dressing, Compression
NEC
Bandage, Liquid, Skin Protectant
OXQ
Dressing Change Tray
PYO
Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Toxicology
Medical Genetics
Unknown
SU
/
subpart-f—general-hospital-and-personal-use-therapeutic-devices
/
KMF
/
K914147
View Source
ALLEVLYN WOUND DRESSING, MODIFICATION
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K914147
510(k) Type
Traditional
Applicant
SMITH & NEPHEW UNITED, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/3/1992
Days to Decision
140 days
Submission Type
Statement