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EWD
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3
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P
02
0008
KARL STORZ AUTOFLUORESCENCE SYSTEM
APWD
PMA Approval
P
95
0042
PINPOINT ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA
APPR
PMA Approval
QNU
Transcutaneous Electrical Nerve Stimulator For The Relief Of Congestion
2
Product Code
OAA
Aid, Visual, For Nausea
N
Product Code
QLV
Field Generator Positioning Device
1
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Stimulator, Transdermal
3
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Implant, Hearing, Active, Middle Ear, Totally Implanted
3
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N
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OWO
Drug-Eluting Sinus Stent
3
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Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification
3
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N
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QOV
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N
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QOX
Multi-Patient Circuit Connector
N
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QQG
Oropharyngeal Electrical Stimulator
2
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QVN
Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus
2
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QXG
Cooperative Powered Surgical Assist Device For Ent Surgery
2
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QZC
External Mechanical Stimulator For The Relief Of Congestion
2
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SCR
Air-Conduction Hearing Aid Software
2
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Last synced on 6 December 2024 at 11:05 pm
EN
/
EN-misc
/
MRK
/
P020008
View Source
KARL STORZ AUTOFLUORESCENCE SYSTEM
Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
KARL STORZ ENDOSCOPY-AMERICA, INC.
Trade Name
KARL STORZ AUTOFLUORESCENCE SYSTEM
Generic Name
SYSTEM, IMAGING, FLUORESCENCE
Decision Date
12/12/2002
Days to Decision
280 days
Decision Code
APWD
FDA Decision
Withdrawal after approval
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Miscellaneous
ESI
Polymer, Natural-Absorbable Gelatin Material
EWD
Protector, Hearing (Insert)
EWE
Protector, Hearing (Circumaural)
LEZ
Aids, Speech Training For The Hearing Impaired (Ac-Powered And Patient-Contact)
LFA
Aids, Speech Training For The Hearing Impaired (Battery-Operated Or Non-Patient)
LFB
Button, Nasal Septal
LRA
Hearing Aid, Tactile
LXV
Apparatus, Vestibular Analysis
MCM
Implant, Cochlear
MHE
Implant, Auditory Brainstem
MJV
Device, Inflation, Middle Ear
MPV
Implant, Hearing, Active, Middle Ear, Partially Implanted
MRK
System, Imaging, Fluorescence
P
02
0008
KARL STORZ AUTOFLUORESCENCE SYSTEM
P
95
0042
PINPOINT ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA
QNU
Transcutaneous Electrical Nerve Stimulator For The Relief Of Congestion
OAA
Aid, Visual, For Nausea
QLV
Field Generator Positioning Device
EPG
Stimulator, Transdermal
OAF
Implant, Hearing, Active, Middle Ear, Totally Implanted
OAQ
Electronic Media, Hyperacusis
OWO
Drug-Eluting Sinus Stent
PGQ
Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification
QJA
Tympanostomy Tube Delivery Product With Drug
QOO
Ventilator Tubing And Accessories
QOP
Respiratory Humidifier For Emergency Use
QOS
Continuous Ventilator
QOT
Emergency Ventilator
QOV
Critical Care Ventilator
QOX
Multi-Patient Circuit Connector
QQG
Oropharyngeal Electrical Stimulator
QVN
Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus
QXG
Cooperative Powered Surgical Assist Device For Ent Surgery
QZC
External Mechanical Stimulator For The Relief Of Congestion
SCR
Air-Conduction Hearing Aid Software
Submissions with No Product Code
Subpart B—Diagnostic Devices
Subpart D—Prosthetic Devices
Subpart E—Neurological Surgical Devices
Subpart E—Surgical Devices
Subpart F—General Hospital and Personal Use Therapeutic Devices
Subpart F—Therapeutic Devices
Subpart G—General Hospital and Personal Use Miscellaneous Devices
Subpart G—Miscellaneous Devices
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
EN
/
EN-misc
/
MRK
/
P020008
View Source
KARL STORZ AUTOFLUORESCENCE SYSTEM
Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
KARL STORZ ENDOSCOPY-AMERICA, INC.
Trade Name
KARL STORZ AUTOFLUORESCENCE SYSTEM
Generic Name
SYSTEM, IMAGING, FLUORESCENCE
Decision Date
12/12/2002
Days to Decision
280 days
Decision Code
APWD
FDA Decision
Withdrawal after approval