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Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—General Hospital and Personal Use Monitoring Devices
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LWH
Counter, Sponge, Surgical
1
Product Code
K
12
1274
PIXEL APP
1
Cleared 510(K)
K
12
0473
PIXEL APP
1
Cleared 510(K)
K
10
0551
ORLOCATE SYSTEM MODEL ORL 100
1
Cleared 510(K)
K
09
3557
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1
Cleared 510(K)
K
07
3180
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1
Cleared 510(K)
K
07
1355
SMARTSPONGE SYSTEM
1
Cleared 510(K)
K
06
2642
RF SURGICAL SYSTEMS INC. DETECTION SYSTEM, MODEL 100A
1
Cleared 510(K)
K
06
1316
MEDLINE SURGICAL SPONGE SCANNER
1
Cleared 510(K)
K
06
0076
SURGICOUNT SAFETY-SPONGE SYSTEM
1
Cleared 510(K)
K
98
2260
MARKWELL GAUZE SPONGE
1
Cleared 510(K)
Show All 15 Submissions
PBZ
Image Processing Device For Estimation Of External Blood Loss
2
Product Code
Subpart D—Prosthetic Devices
CFR Sub-Part
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Subpart E—Surgical Devices
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Last synced on 16 August 2024 at 11:05 pm
SU
/
subpart-c—general-hospital-and-personal-use-monitoring-devices
/
LWH
/
K100551
View Source
ORLOCATE SYSTEM MODEL ORL 100
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K100551
510(k) Type
Traditional
Applicant
HALDOR ADVANCED TECHNOLOGIES LTD
Country
Israel
FDA Decision
Substantially Equivalent
Decision Date
8/12/2010
Days to Decision
167 days
Submission Type
Summary
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
LWH
Counter, Sponge, Surgical
K
12
1274
PIXEL APP
K
12
0473
PIXEL APP
K
10
0551
ORLOCATE SYSTEM MODEL ORL 100
K
09
3557
SMARTWAND-DTX
K
07
3180
SMARTSPONGE PLUS SYSTEM
K
07
1355
SMARTSPONGE SYSTEM
K
06
2642
RF SURGICAL SYSTEMS INC. DETECTION SYSTEM, MODEL 100A
K
06
1316
MEDLINE SURGICAL SPONGE SCANNER
K
06
0076
SURGICOUNT SAFETY-SPONGE SYSTEM
K
98
2260
MARKWELL GAUZE SPONGE
Show All 15 Submissions
PBZ
Image Processing Device For Estimation Of External Blood Loss
Subpart D—Prosthetic Devices
Subpart E—Neurological Surgical Devices
Subpart E—Surgical Devices
Subpart F—General Hospital and Personal Use Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Toxicology
Medical Genetics
Unknown
SU
/
subpart-c—general-hospital-and-personal-use-monitoring-devices
/
LWH
/
K100551
View Source
ORLOCATE SYSTEM MODEL ORL 100
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K100551
510(k) Type
Traditional
Applicant
HALDOR ADVANCED TECHNOLOGIES LTD
Country
Israel
FDA Decision
Substantially Equivalent
Decision Date
8/12/2010
Days to Decision
167 days
Submission Type
Summary