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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
161089–161112 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 22, 1982
CLOTTING TIME REAGENT
K820084 · GJB
American Dade
Hematology · 41d
Cleared Feb 22, 1982
INTELECT MODEL 700
K827033
Chattanooga Group, Inc.
Radiology · 48d
Cleared Feb 22, 1982
INTELECT MODEL 200
K827034
Chattanooga Group, Inc.
Radiology · 48d
Cleared Feb 19, 1982
MODEL 500 VERI/500
K813108 · IPF
Verite
Physical Medicine · 108d
Cleared Feb 19, 1982
ELECTROC-GYM
K813181 · IPF
Electrola
Physical Medicine · 99d
Cleared Feb 19, 1982
ERIKA CAPD PREP KIT #30-9501-5
K820179 · FKX
Erika, Inc.
Gastroenterology & Urology · 28d
Cleared Feb 18, 1982
TNS MK I STIMULATOR
K812612 · GZJ
Edu Kit , Ltd.
Neurology · 156d
Cleared Feb 18, 1982
MODEL 2650 HIGH CAPACITY DUAL SYRINGE
K813644 · FRN
Harvard Apparatus, Inc.
General Hospital · 49d
Cleared Feb 18, 1982
WELLCOGEN GROUP B
K820069 · GTZ
Burroughs Wellcome Co.
Microbiology · 37d
Cleared Feb 18, 1982
SIEMENS SIRESKOP 4
K820111 · KXJ
Siemens Corp.
Radiology · 34d
Cleared Feb 18, 1982
AUTOMATIC TRAY (ACT I & ACT II
K820117 · KPX
Burbury & Cutter Ind., Inc.
Radiology · 31d
Cleared Feb 18, 1982
PODIOSCOPE BY ARROW
K820119 · KPW
Arrow X-Ray Corp.
Radiology · 31d
Cleared Feb 18, 1982
THEIR ELECTRO SURGICAL COUTERY PENCIL
K820156 · GEI
Shannon Group
General & Plastic Surgery · 30d
Cleared Feb 18, 1982
LAMINATED KARAYA GUM WASHERS
K820167 · EXB
Atlantic Surgical
Gastroenterology & Urology · 28d
Cleared Feb 18, 1982
VENTILATOR MODELS
K820220 · CBK
Pneupac , Ltd.
Anesthesiology · 22d
Cleared Feb 18, 1982
PREFILLED SPECIMEN CONTAINER
K820246 · KDT
Sage Products, Inc.
Pathology · 20d
Cleared Feb 18, 1982
EXTERNAL VENTRICULAR DRAINAGE SYS.
K820247 · JXG
American Heyer Schulte
Neurology · 20d
Cleared Feb 18, 1982
BI-LEVEL ASSAYED URINE METAL CONTROL
K820255 · JJY
Ortho Diagnostic Systems, Inc.
Chemistry · 17d
Cleared Feb 18, 1982
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES
K820263 · CHH
Eastman Kodak Company
Chemistry · 16d
Cleared Feb 18, 1982
RAICHEM GOT (AST) REAGENT
K820270 · CIT
Reagents Applications, Inc.
Chemistry · 16d
Cleared Feb 18, 1982
4050/4051 ULTRASPEC
K820273 · JJQ
Lkb Instruments, Inc.
Chemistry · 16d
Cleared Feb 18, 1982
INTRAVASCULAR ADMINISTRATION SET
K820278 · FPA
Y
General Hospital · 16d
Cleared Feb 18, 1982
SYVA ADVANCE SYST. EMIT-AMD GENT. ASSAY
K820285 · LCQ
Syva Co.
Toxicology · 16d
Cleared Feb 18, 1982
SIEMENS SIRESKOP 4
K827065
Siemens Medical Solutions USA, Inc.
Radiology · 34d