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
93121–93144 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 25, 1997
D'ARC EYE CARE SUNGLASSES
K972490 · HQY
M & R Dist.
Ophthalmic · 23d
Cleared Jul 24, 1997
CORELIFE
K964230 · FMF
Core Healthcare , Ltd.
General Hospital · 274d
Cleared Jul 24, 1997
COLORMATE III
K964590 · MQM
Chromatics Color Sciences Intl., Inc.
Chemistry · 251d
Cleared Jul 24, 1997
CYBERREN
K970989 · KPF
Cybernius Medical , Ltd.
Gastroenterology & Urology · 128d
Cleared Jul 24, 1997
BARD NO-RINSE HEMOCONCENTRATOR AND ACCESSORY KIT
K971180 · KDI
C.R. Bard, Inc.
Gastroenterology & Urology · 115d
Cleared Jul 24, 1997
RADIONICS CONTOUR FLEX VALVE, RADIONICS CONTOUR FLEX PLUS VALVE
K971511 · JXG
Radionics, Inc.
Neurology · 87d
Cleared Jul 24, 1997
AMS COAGULOOP RESECTION ELECTRODE
K971512 · FAS
American Medical Systems, Inc.
Gastroenterology & Urology · 87d
Cleared Jul 24, 1997
KSEA SEMI-RIGID HYSTEROSCOPE AND ACCESSORIES
K971518 · HIH
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 90d
Cleared Jul 24, 1997
REACH ANTIBACTERIAL TOOTHBRUSH
K971589 · EFW
Personal Products Co.
Dental · 84d
Cleared Jul 24, 1997
MEDI-TECH 4 AND 5 FRENCH NIGHTHAWK FLUSH ANGIOGRAPHIC CATHETERS
K971607 · DQO
Boston Scientific Corp
Cardiovascular · 84d
Cleared Jul 24, 1997
PATTISON ESOPHAGEAL DILATOR
K971615 · KNQ
Tri-Med Specialties, Inc.
Gastroenterology & Urology · 83d
Cleared Jul 24, 1997
DENTALIS KEZ ENDODONITC SEALER
K971642 · EMA
Neodental Chemical Products Co., Ltd.
Dental · 83d
Cleared Jul 24, 1997
SIGNA PROFILE WRIST COIL AND MOBILE SITING OPTIONS
K971668 · LNH
GE Medical Systems
Radiology · 79d
Cleared Jul 24, 1997
DEPUY ORTHOTECH HEAVY DUTY VEST RESTRAINT
K971742 · FMQ
Depuy, Inc.
General Hospital · 73d
Cleared Jul 24, 1997
IMPLEX CONTINUUM POROUS PATELLAR
K971789 · JWH
Implex Corp.
Orthopedic · 71d
Cleared Jul 24, 1997
PANCREATIC AMYLASE, ETHYLIDENE BLOCKED-PNPG7 ENZYME COLORIMETRIC TEST
K971825 · JFJ
Randox Laboratories, Ltd.
Chemistry · 69d
Cleared Jul 24, 1997
CYTOLOGY BRUSH
K971849 · HHT
Team Technologies, Inc.
Obstetrics & Gynecology · 66d
Cleared Jul 24, 1997
CHOLESTECH BUN/CREATININE TEST SYSTEM
K972012 · CDN
Cholestech Corp.
Chemistry · 55d
Cleared Jul 24, 1997
ESR CONTROL-HC HEMATOLOGY ERYTHROCYTE SEDIMENTATION
K972170 · JPK
R&D Systems, Inc.
Hematology · 45d
Cleared Jul 24, 1997
ESR CONTROL-M HEMATOLOGY ERYTHROCYTE SEDIMENTATION
K972172 · JPK
R&D Systems, Inc.
Hematology · 45d
Cleared Jul 24, 1997
PROTECTIVE RESTRAINT(MODELS #302,440,750 AND A30 X 30 BELT.
K972338 · FMQ
Geriatric Products, Inc.
General Hospital · 31d
Cleared Jul 24, 1997
HP ENDOVAGINAL/ENDORECTAL PROBE, HP IMAGE POINT ULTRASOUND SYSTEM
K972348 · ITX
Hewlett-Packard Co.
Radiology · 30d
Cleared Jul 24, 1997
CEDIA DIGOXIN CALIBRATORS
K972433 · DLJ
Boehringer Mannheim Corp.
Toxicology · 24d
Cleared Jul 24, 1997
RAMY INTEGRATED NEEDLE SYRINGE
K972452 · FMF
Alshifa Medical Syringes Mfg. Co., Ltd.
General Hospital · 78d