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
104809–104832 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 18, 1995
VICRYL RAPIDE SUTURE
K944110 · GAM
Ethicon, Inc.
General & Plastic Surgery · 148d
Cleared Jan 18, 1995
MEDI-PUMP
K944399 · BTA
Thomas Industries
General & Plastic Surgery · 132d
Cleared Jan 18, 1995
SHOULDER RETRACTOR
K944613 · KPR
Northwest Medical Physics Center
Radiology · 120d
Cleared Jan 18, 1995
SOUND SELECTOR ITE (SSI), BTE (SSB), MINI BTE( SSM)
K944980 · ESD
Hearing Solutions, Inc.
Ear, Nose, Throat · 99d
Cleared Jan 18, 1995
HOWMEDICA ALUMINA FEMORAL HEAD
K945091 · LZO
Howmedica Corp.
Orthopedic · 93d
Cleared Jan 18, 1995
ECLIPSE 3200
K945126 · GEX
Cardiogenes
General & Plastic Surgery · 91d
Cleared Jan 18, 1995
QUIK-STITCH
K945170 · GCJ
Coral Medical, Inc.
General & Plastic Surgery · 89d
Cleared Jan 18, 1995
NASOPHARYNGOSCOPES, BRONCHOSCOPES, TRACHEOSCP[ES AND ESOPHAGOSCOPES,...
K945381 · EOB
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 77d
Cleared Jan 18, 1995
PREMIER MIRROR WARMER
K945395 · ETF
Premier Dental Products Co.
Ear, Nose, Throat · 76d
Cleared Jan 18, 1995
ANTERIOR/POSTERIOR EPISTAXIS CATHETER
K945556 · EMX
Ultracell Medical Technologies, Inc.
Ear, Nose, Throat · 65d
Cleared Jan 18, 1995
UROTEK LASER CATHETER
K945560 · GEX
Energy Life Systems Corp.
General & Plastic Surgery · 79d
Cleared Jan 18, 1995
MOBILIX MOBILE X-RAY TABLE
K945842 · IXR
GE Medical Systems
Radiology · 49d
Cleared Jan 18, 1995
VACUTAINER(R) BRAND PLUS PST(TM) PLASMA SEPARATION TUBE
K945952 · JKA
Bd Becton Dickinson Vacutainer...
Chemistry · 43d
Cleared Jan 18, 1995
KS SEMI-RIGID MICRO-ENDOSCOPES AND ACCESSORIES FOR ADULT AND PEDIATRIC...
K946164 · GCJ
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 30d
Cleared Jan 18, 1995
TROCAR CANNULA STABILIZER
K950005 · GCJ
Advanced Surgical, Inc.
General & Plastic Surgery · 15d
Cleared Jan 17, 1995
EXACTECH CEMENTED TOTAL KNEE SYSTEM, TIBIAL COMPONENTS
K933610 · JWH
Exactech, Inc.
Orthopedic · 539d
Cleared Jan 17, 1995
BIOMERIEUX HEMOLAB COFAC VII
K935850 · GJT
Biomerieux Vitek, Inc.
Hematology · 405d
Cleared Jan 17, 1995
BIOMERIEUX HEMOLAB COFAC X
K935851 · GJT
Biomerieux Vitek, Inc.
Hematology · 405d
Cleared Jan 17, 1995
GLUCOCHEK
K940215 · CGA
Clinical Diagnostics, Inc.
Chemistry · 368d
Cleared Jan 17, 1995
QUEST CORONARY SINUS PERFUSION CANNULA
K941166 · DWF
Quest Medical, Inc.
Cardiovascular · 312d
Cleared Jan 17, 1995
ORTHOLOC ADVANTIM LSI POSTERIOR STABLIZED ALL POLYTHYLENE TIBIAL COMPONENT
K941755 · JWH
Wrightmedicaltechnologyinc
Orthopedic · 284d
Cleared Jan 17, 1995
MODEL 2721 CLINICAL REFRACTOMETER
K941901 · JRE
Vee Gee Scientific, Inc.
Chemistry · 273d
Cleared Jan 17, 1995
MODEL 2740 CLINICAL REFRACTOMETER
K941903 · JRE
Vee Gee Scientific, Inc.
Chemistry · 273d
Cleared Jan 17, 1995
MODEL 2730 CLINICAL REFRACTOMETER
K941906 · JRE
Vee Gee Scientific, Inc.
Chemistry · 273d