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
91177–91200 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 12, 1998
KRONNER LOW PROFILE SCOPE HOLDER
K973543 · GCJ
Kronner Prototypes, Inc.
General & Plastic Surgery · 116d
Cleared Jan 12, 1998
SONIX HEARING AID FITTING AND PROGRAMMING SYSTEM
K973880 · ESD
Sonix Technologies, Inc.
Ear, Nose, Throat · 90d
Cleared Jan 12, 1998
LAPAROSCOPIC GASTROSTOMY KIT
K973891 · KNT
Applied Medical Resources
Gastroenterology & Urology · 90d
Cleared Jan 12, 1998
BAUSCH & LOMB2 SENSITIVE EYES MULTI-PURPOSE SOLUTION
K973921 · LPN
Bausch & Lomb, Inc.
Ophthalmic · 89d
Cleared Jan 12, 1998
LUGE GUIDE WIRE
K973945 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 88d
Cleared Jan 12, 1998
ORBITAL RECONSTRUCTION PLATES
K973982 · HRS
Howmedica, Inc.
Orthopedic · 84d
Cleared Jan 12, 1998
VAPR
K974022 · GEI
Mitek Products
General & Plastic Surgery · 90d
Cleared Jan 12, 1998
SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940 ERBIUM CRYSTALASE
K974039 · GEX
Schwartz Electro-Optics, Inc.
General & Plastic Surgery · 88d
Cleared Jan 12, 1998
FS IV MINI C-ARM SYSTEM
K974058 · JAA
Hologic, Inc.
Radiology · 77d
Cleared Jan 12, 1998
ESSENTIAL SHAVER SYSTEM
K974232 · EQJ
Gyrus Ent LLC
Ear, Nose, Throat · 61d
Cleared Jan 12, 1998
ENCORE LINEAR POROUS COATED HIP
K974294 · LPH
Encore Orthopedics, Inc.
Orthopedic · 59d
Cleared Jan 12, 1998
OSTEONICS SERIES 7000 TOTAL KNEE ANTERIOR FEMORAL BLOCKS
K974434 · HRY
Osteonics Corp.
Orthopedic · 49d
Cleared Jan 12, 1998
SUNGLASSES
K974511 · HQY
Sun World Intl., Inc.
Ophthalmic · 42d
Cleared Jan 12, 1998
INTERCEPTRE LAPAROSCOPIC INSTRUMENTS
K974592 · GCJ
Smith & Nephew, Inc.
General & Plastic Surgery · 34d
Cleared Jan 11, 1998
CT CELLULOSER TRIACETATE HOLLOW FIBER DIALYZER (CT-110G/CT-190G)
K970663 · MSF
Baxter Healthcare Corp
Gastroenterology & Urology · 324d
Cleared Jan 09, 1998
SNORING CONTROL DEVICE
K963591 · LRK
Kenneth Hilsen
Dental · 487d
Cleared Jan 09, 1998
THE HARVARD LIBRARY
K970678 · MRZ
Harvard Apparatus, Inc.
General Hospital · 319d
Cleared Jan 09, 1998
SOMNUS MODEL 6000 DISPOSABLE TISSUE COAGULATING ELECTRODE
K970837 · GEI
Somnus Medical Technologies, Inc.
General & Plastic Surgery · 308d
Cleared Jan 09, 1998
SOMNUS MODEL 30XX DISPOSABLE TRI-NEEDLE COAGULATING ELECTRODE
K970838 · GEI
Somnus Medical Technologies, Inc.
General & Plastic Surgery · 308d
Cleared Jan 09, 1998
IOTEC TROCAR AND FLEXIBLE CANNULA
K970888 · GCJ
Iotec Industries
General & Plastic Surgery · 304d
Cleared Jan 09, 1998
GLUTATECT
K971888 · JOJ
Alden Scientific, Inc.
General Hospital · 233d
Cleared Jan 09, 1998
TINA-QUANT PREALBUMIN
K972638 · JZJ
Boehringer Mannheim Corp.
Immunology · 178d
Cleared Jan 09, 1998
TINA-QUANT HAPTOGLOBIN
K972639 · DAD
Boehringer Mannheim Corp.
Immunology · 178d
Cleared Jan 09, 1998
TINA-QUANT ALPHA PARTICLE-1-ANTITRYPSIN ASSAY
K972640 · DEM
Boehringer Mannheim Corp.
Immunology · 178d