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
91705–91728 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Nov 21, 1997
TRITEST REAGENT CD3 FITC/CD8 PE/CD45 PERCP
K970326 · GKZ
Becton Dickinson Immunocytometry Systems
Hematology · 297d
Cleared Nov 21, 1997
GREATBATCH SCIENTIFIC MR COMPATIBLE ARTHROSCOPES AND SMALL JOINT ARTHROSCOPES
K971781 · HRX
Wilson Greatbatch Technologies, Inc.
Orthopedic · 191d
Cleared Nov 21, 1997
FLEXTIP GRASPER
K972450 · EOB
Endius, Inc.
Ear, Nose, Throat · 144d
Cleared Nov 21, 1997
URESIL GUIDEWIRE
K972582 · FGE
Uresil Corp.
Gastroenterology & Urology · 134d
Cleared Nov 21, 1997
ACETABULAR SHELLS WITH MESH INGROWTH SURFACE
K973163 · LPH
Howmedica Corp.
Orthopedic · 88d
Cleared Nov 21, 1997
DOW CORNING SILASTIC ELASTOMER Q7-4750
K973166 · MIB
Technical Products, Inc.
General & Plastic Surgery · 88d
Cleared Nov 21, 1997
SMARTVIEW OPTIONS FOR HISPEED CT/I
K973168 · JAK
GE Medical Systems
Radiology · 88d
Cleared Nov 21, 1997
SEIZURE EMERGENCY EQUIPMENT KIT
K973176 · KGA
Lotus Technologies
Anesthesiology · 88d
Cleared Nov 21, 1997
PROSTATE SEEDING NEEDLE
K973184 · IWJ
Promex, Inc.
Radiology · 88d
Cleared Nov 21, 1997
ACCUPROBE 450, ACCUPROBE 550/530 AND THE ACCUPROBE 600 SERIES
K973190 · GEI
Cryomedical Sciences, Inc.
General & Plastic Surgery · 88d
Cleared Nov 21, 1997
LUXSCOPE
K973193 · HQF
Luxtec Corp.
Ophthalmic · 88d
Cleared Nov 21, 1997
OLYMPUS SUBFASCIAL ENDOSCOPIC PERFORATING VEIN SURGERY (SEPS) SYSTEM, ITS...
K973232 · GCJ
Olympus Winter & Ibe GmbH
General & Plastic Surgery · 85d
Cleared Nov 21, 1997
SPIROSAFE FILTER
K973314 · CAH
Micro Direct, Inc.
General Hospital · 79d
Cleared Nov 21, 1997
ELECSYS AFP
K973351 · LOJ
Boehringer Mannheim Corp.
Immunology · 77d
Cleared Nov 21, 1997
K-PISTON WITH BAND HOOK /ANGULAR PISTON
K973356 · ETB
Heinz Kurz
Ear, Nose, Throat · 74d