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
91177–91200 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 24, 1997
PERIPHERALLY INSERTED CENTRAL
K971999 · LJS
B.Braun Medical, Inc.
General Hospital · 178d
Cleared Nov 24, 1997
NEXGEN COMPLETE KNEE SOLUTION CONVEX INSET PATELLA COMPONENT
K972270 · JWH
Zimmer, Inc.
Orthopedic · 166d
Cleared Nov 24, 1997
SENDAX MDI (MINI DENTAL IMPLANT)
K972351 · DZE
Sendax Mdic Management, Inc.
Dental · 153d
Cleared Nov 24, 1997
CHARTERMED TPN-EVA BAGS
K973103 · KPE
Chartermed, Inc.
General Hospital · 97d
Cleared Nov 24, 1997
FLUORO-TEX SURGICAL MEMBRANE
K973178 · DXZ
Bridger Biomed, Inc.
Cardiovascular · 91d
Cleared Nov 24, 1997
WILSON-COOK STRICTURE MEASURING CATHETER
K973205 · ODD
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 90d
Cleared Nov 24, 1997
BOSTON LIQUID ENZYMATIC CLEANER
K973217 · LPN
Polymer Technology Corp.
Ophthalmic · 89d
Cleared Nov 24, 1997
KARL STORZ DIRECT COUPLED CAMERA HEAD
K973252 · FET
Karl Storz Imaging, Inc.
Gastroenterology & Urology · 87d
Cleared Nov 24, 1997
J-TIP INJECTOR
K973254 · KZE
National Medical Products, Inc.
General Hospital · 87d
Cleared Nov 24, 1997
WHITESIDE BIOMECHANICS, INC. CERAMIC UNIPOLAR FEMORAL HEAD
K973261 · LZO
Whiteside Biomechanics, Inc.
Orthopedic · 87d
Cleared Nov 24, 1997
EXTEND HIP STEM
K973296 · JDI
Wrightmedicaltechnologyinc
Orthopedic · 83d
Cleared Nov 24, 1997
PANOVIEW PLUS TELESCOPE, 3.5MM, O,WL 300MM/25,WL 300MM/0,WL 180MM
K973359 · GCJ
Richard Wolf Medical Instruments Corp.
General & Plastic Surgery · 77d
Cleared Nov 24, 1997
CERTODYN RAECG UNIVERSAL ADAPTER
K973371 · DQY
B.Braun Medical, Inc.
Cardiovascular · 77d
Cleared Nov 24, 1997
SOFTFORM FACIAL IMPLANT
K973462 · FTL
Tissue Technologies, Inc.
General & Plastic Surgery · 73d
Cleared Nov 24, 1997
VISUAL ENDOSCOPIC NON-ALCOHOL ULTRACELL SPONGE (VENUS)
K973558 · FEB
Ultracell Medical Technologies, Inc.
General Hospital · 66d
Cleared Nov 24, 1997
PROVIL NOVO
K973694 · ELW
Heraeus Kulzer, Inc.
Dental · 59d
Cleared Nov 24, 1997
SYNCHRON SYSTEM HEMOGLOBIN ALC REAGENT
K973696 · LCP
Beckman Instruments, Inc.
Hematology · 59d
Cleared Nov 24, 1997
PRE-FILLED SYRINGE FOR KOALA IUP
K973746 · HFN
Clinical Innovations, Inc.
Obstetrics & Gynecology · 54d
Cleared Nov 24, 1997
PROSPECTOR PLUS (CODE NAME : RD-0508)
K973881 · EJT
J.F. Jelenko & Co., Inc.
Dental · 41d
Cleared Nov 24, 1997
17 B-ESTRADIOL (ELISA)
K973901 · CHP
Kmi Diagnostics, Inc.
Chemistry · 41d
Cleared Nov 24, 1997
UREA-SL ASSAY CATALOGUE NUMBER 239-10, 239-30
K973931 · CDQ
Diagnostic Chemicals , Ltd.
Chemistry · 40d
Cleared Nov 24, 1997
SYNCHRON SYSTEMS C-REACTIVE PROTEIN (CRP) REAGENT
K974050 · DCK
Beckman Instruments, Inc.
Immunology · 31d
Cleared Nov 21, 1997
TRITEST REAGENT CD3 FITC/CD4 PE/CD45 PERCP
K965053 · GKZ
Becton Dickinson Immunocytometry Systems
Hematology · 338d
Cleared Nov 21, 1997
DIGITAL ADD-ON BUCKY
K970136 · KPR
Swissray Teleray AG
Radiology · 310d