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
93361–93384 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 22, 1997
FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHSIS OF UNSTABLE...
K970258 · HRS
Ferguson Medical
Orthopedic · 119d
Cleared May 22, 1997
FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF...
K970280 · HSB
Ferguson Medical
Orthopedic · 119d
Cleared May 22, 1997
3-CCD DIGITAL CAMERA
K970605 · GCJ
Envision Medical Corp.
General & Plastic Surgery · 93d
Cleared May 22, 1997
CRYSTAL-EEG MODEL 10 (MODEL 10)
K970672 · OMC
Cleveland Medical Devices, Inc.
Neurology · 87d
Cleared May 22, 1997
INTER-OP POROUS REVISION SHELL WITH SEALABLE SCREWHOLES
K970705 · LPH
Sulzer Orthopedics, Inc.
Orthopedic · 85d
Cleared May 22, 1997
INTER-OP POROUS PROTRUSIO SHELL WITH SEALABLE SCREWHOLES
K970706 · LPH
Sulzer Orthopedics, Inc.
Orthopedic · 85d
Cleared May 22, 1997
DURACON EXTRA-SMALL STABILIZER TIBIAL INSERT & BASEPLATE
K970758 · JWH
Howmedica Corp.
Orthopedic · 80d
Cleared May 22, 1997
INSTRUMENT HOLDER
K970900 · GCJ
Contour Fabricators, Inc.
General & Plastic Surgery · 72d
Cleared May 22, 1997
DEROYAL INDUSTRIES, INC. DISPOSABLE BIPOLAR ELECTROSURGICAL CABLE
K970993 · GEI
Deroyal Industries, Inc.
General & Plastic Surgery · 64d
Cleared May 22, 1997
NEO-CARE LUMBER PUNCTURE KIT
K970997 · MIA
Klein-Baker Medical, Inc.
Anesthesiology · 64d
Cleared May 22, 1997
AYURVEDIC TONGUE CLEANER
K971025 · LCN
Calello Martinez P.C.
Dental · 63d
Cleared May 22, 1997
MEMOREG
K971155 · ELW
Heraeus Kulzer, Inc.
Dental · 55d
Cleared May 22, 1997
ML DISPOSABLE ALK TUBING
K971173 · KYG
Med-Logics, Inc.
Ophthalmic · 52d
Cleared May 22, 1997
DSL ACTIVE T4 EIA
K971269 · KLI
Diagnostic Systems Laboratories, Inc.
Chemistry · 48d
Cleared May 22, 1997
DSL ACTIVE T3 EIA
K971270 · CDP
Diagnostic Systems Laboratories, Inc.
Chemistry · 48d
Cleared May 22, 1997
NT SERIES ENDODONTIC FILES, MAC SERIES ENDODONTIC FILES
K971319 · EKS
Tycom Dental
Dental · 42d
Cleared May 22, 1997
KIRWAN MODEL 28 1000 BIPOLAR COAGULATOR
K971341 · GEI
Kirwan Surgical Products, Inc.
General & Plastic Surgery · 42d
Cleared May 22, 1997
OSTEONICS ACETABULAR WEDGE SYSTEM
K971422 · MEH
Osteonics Corp.
Orthopedic · 35d
Cleared May 22, 1997
PROSPORE II
K971430 · FRC
Raven Biological Laboratories, Inc.
General Hospital · 35d
Cleared May 22, 1997
AMBUVAC
K971548 · OMP
Kinetic Concepts, Inc.
General & Plastic Surgery · 24d
Cleared May 22, 1997
SIL-TEC SMALL/LARGE BORE TUBING/SIL-TEC HIGH DUROMETER TUBING/SIL-TEC...
K971613 · MIB
Technical Products, Inc.
General & Plastic Surgery · 20d
Cleared May 21, 1997
SYMPHONY NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K963254 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 275d
Cleared May 21, 1997
UNIPOLAR HOOK ELECTRODE (5MM .340MM)/UNIPOLAR HOOK ELECTRODE (5MM. 420MM)
K964329 · GEI
Richard Wolf Medical Instruments Corp.
General & Plastic Surgery · 203d
Cleared May 21, 1997
ROCHE COBAS AMPLICOR ANALYZER
K964506 · JJF
Roche Molecular Systems, Inc.
Chemistry · 194d