FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
89233–89256 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 21, 1998
ORCA CARDIOPULMONARY EXERCISE TESTING SYSTEM
K974200 · BZM
Orca Diagnostics Corp.
Anesthesiology · 253d
Cleared Jul 21, 1998
ITI STENT
K980290 · FGE
Intratherapeutics, Inc.
Gastroenterology & Urology · 176d
Cleared Jul 21, 1998
EPILASER NORMAL MODE RUBY LASER
K980517 · GEX
Palomar Medical Products, Inc.
General & Plastic Surgery · 161d
Cleared Jul 21, 1998
MPS HUBER NEEDLE EXTENSION SET
K982047 · FPA
Medical Product Specialists
General Hospital · 41d
Cleared Jul 21, 1998
CONTRAST CONTROL DEVICE
K982123 · FPA
Medex, Inc.
General Hospital · 35d
Cleared Jul 21, 1998
WALLSTENT ENDOPROSTHESIS
K982184 · JCT
Boston Scientific Scimed, Inc.
General & Plastic Surgery · 29d
Cleared Jul 20, 1998
WORKING ELEMENTS, RESECTOSCOPE SHEATHS, ELECTRODES, OBTURATORS, ENDOSCOPES
K980302 · HIH
Richard Wolf Medical Instruments Corp.
Obstetrics & Gynecology · 174d
Cleared Jul 20, 1998
PRO VISION
K980648 · LLZ
Algotec Systems, Ltd.
Radiology · 151d
Cleared Jul 20, 1998
BINDAZYME ANTI-PR3 ENZYME IMMUNOASSAY KIT
K981029 · MOB
The Binding Site, Ltd.
Immunology · 123d
Cleared Jul 20, 1998
BINDAZYME ANTI-MPO ENZYME IMMUNOASSAY KIT
K981030 · MOB
The Binding Site, Ltd.
Immunology · 123d
Cleared Jul 20, 1998
DORNIER MEDILAS E
K981438 · GEX
Dornier Surgical Products, Inc.
General & Plastic Surgery · 90d
Cleared Jul 20, 1998
INTEGRATED DRIVE/PUMP SYSTEM FOR OTOLARYNGOLOGY
K981637 · ERL
Linvatec Corp.
Ear, Nose, Throat · 73d
Cleared Jul 20, 1998
STATUSFLOW
K982231 · GKZ
R&D Systems, Inc.
Hematology · 25d
Cleared Jul 17, 1998
DUAL HOOK FIBEROPTIC DELIVERY SYSTEM
K970069 · GEX
Ihd, Inc.
General & Plastic Surgery · 555d
Cleared Jul 17, 1998
800 SERIES SURGICAL LASER SYSTEM ORION SERIES SURGICAL LASER SYSTEM ANGLED...
K972575 · GEX
Laserscope
General & Plastic Surgery · 372d
Cleared Jul 17, 1998
BMC RF CANNULA
K972846 · GXI
Baylis Medical Co., Inc.
Neurology · 350d
Cleared Jul 17, 1998
KODAK PRO-MEDICAL DIGITAL CAMERA SYSTEM
K973430 · GCJ
Eastman Kodak Company
General & Plastic Surgery · 310d
Cleared Jul 17, 1998
COLORPAC TOXIN A
K980185 · LLH
Bd Becton Dickinson Vacutainer...
Microbiology · 178d
Cleared Jul 17, 1998
CMS BLIZZARD 700 SERIES MODELS 730, 740,750,760,770,780 & 790
K980668 · GEH
Cryomedical Sciences, Inc.
General & Plastic Surgery · 147d
Cleared Jul 17, 1998
CMS BLIZZARD 700 SERIES MODELS 710, 711, 712, 720, 721 AND 722
K980670 · GEH
Cryomedical Sciences, Inc.
General & Plastic Surgery · 147d
Cleared Jul 17, 1998
HAKIM MICRO PROGRAMMABLE VALVE SYSTEM
K980778 · JXG
Johnson & Johnson Professionals, Inc.
Neurology · 137d
Cleared Jul 17, 1998
Squirt Fluid Delivery System
K981417 · QEY
Merit Medical Systems, Inc.
Cardiovascular · 88d
Cleared Jul 17, 1998
NOMOS BAT ULTRASOUND LOCALIZATION AND POSITIONING SYSTEM
K981424 · IYE
Nomos Corp.
Radiology · 88d
Cleared Jul 17, 1998
OMNITECH RESECTOSCOPE ROLLER ELECTRODE
K981463 · KNF
Omnitech Systems, Inc.
Obstetrics & Gynecology · 85d