FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
90673–90696 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jan 09, 1998
BI-O.K. EO GAS BIOLOGICAL TEST-PAK (269305,269310,269320)
K972747 · FRC
Propper Mfg. Co., Inc.
General Hospital · 170d
Cleared Jan 09, 1998
GALLINI ABS DEVICE
K973152 · KNW
Gallini U.S., LLC
Gastroenterology & Urology · 140d
Cleared Jan 09, 1998
ARTHROCARE SINUS ELECTROSURGERY SYSTEM
K973478 · GEI
Arthrocare Corp.
General & Plastic Surgery · 116d
Cleared Jan 09, 1998
LIFE PAK 12
K973486 · MKJ
Physio-Control Corp.
Cardiovascular · 116d
Cleared Jan 09, 1998
MEDTRONIC INSTENT ESOPHACOIL ESOPHAGEAL STENT SYSTEM AND ESOPHACOIL EXTENSION...
K973584 · ESW
Medtech Instruments
Gastroenterology & Urology · 109d
Cleared Jan 09, 1998
ELASTIC MANDIBULAR ADVANCEMENT - TITRATION (EMA-T) APPILANCE
K973884 · LRK
Frantz Design, Inc.
Dental · 87d
Cleared Jan 09, 1998
CADD-DIPLOMAT PC COMMUNICATIONS SYSTEM AND THE CADD- AMBASSADOR PUMP...
K973917 · FRN
Sims Deltec, Inc.
General Hospital · 86d
Cleared Jan 09, 1998
CODMAN INTRACRANIAL BOLT
K974088 · GWM
Johnson & Johnson Professionals, Inc.
Neurology · 71d
Cleared Jan 09, 1998
KERR COMPOMER
K974105 · EBF
Sybron Dental Specialties, Inc.
Dental · 70d