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
85441–85464 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 12, 1999
EXPRESSEYE
K992473 · GWN
Optomotor Laboratories
Neurology · 17d
Cleared Aug 12, 1999
GALLINI BIOSYSTEM BONE MARROW ASPIRATION/BIOPSY NEEDLE
K992499 · KNW
Gallini U.S., LLC
Gastroenterology & Urology · 17d
Cleared Aug 12, 1999
CONVERTORS BREATHABLE SURGICAL GOWNS
K992514 · FYA
Allegiance Healthcare Corp.
General Hospital · 15d
Cleared Aug 11, 1999
BUFFALO FILTER VIROSAFE HRF- #VSHRFO1
K983333 · FYD
Buffalo Filter Co., Inc.
General Hospital · 322d
Cleared Aug 11, 1999
BUFFALO FILTER VIROSAFE 18 FILTER-CATALOG #VSO1801
K983364 · FYD
Buffalo Filter Co., Inc.
General Hospital · 321d
Cleared Aug 11, 1999
JETSONIC 2000
K990545 · KOJ
Sds Dental, Inc.
Dental · 170d
Cleared Aug 11, 1999
GONOSTAT GONOCOCCAL DETECTION KIT
K991268 · LSL
Sierra Diagnostics
Microbiology · 120d
Cleared Aug 11, 1999
PARAGON
K991481 · EJJ
Lancer Orthodontics, Inc.
Dental · 105d
Cleared Aug 11, 1999
NITRILE EXAMINATION GLOVES POWDER FREE (WHITE)
K991776 · LZA
Seltom Pacific Sdn. Bhd.
General Hospital · 78d
Cleared Aug 11, 1999
NITRILE EXAMINATION GLOVES POWDER FREE (BLUE)
K991779 · LZA
Seltom Pacific Sdn. Bhd.
General Hospital · 78d
Cleared Aug 11, 1999
ABX PENTRA 120 RETIC AUTOMATED HEMATOLOGY ANALYZER
K991839 · GKZ
Abx Diagnostics
Hematology · 75d
Cleared Aug 11, 1999
LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, 3
K992550 · JJY
Bio-Rad
Chemistry · 12d
Cleared Aug 10, 1999
CORDIS ENDOVASCULAR TEMPORARY OCCLUSION BALLOON CATHETER
K984214 · DXC
Cordis Neurovascular, Inc.
Cardiovascular · 259d
Cleared Aug 10, 1999
DRX NTX OR, OSTEOMARK NTX DIRECT RESPONSE
K984530 · JFY
Metrika, Inc.
Chemistry · 232d
Cleared Aug 10, 1999
KELLER VITAL SIGNS MONITOR, KMS 890+
K990648 · DXN
Keller Medical Specialties Products,...
Cardiovascular · 162d
Cleared Aug 10, 1999
LAGLOVE BRAND BLUE COLOLRED NITRILE EXAMINATION GLOVE (POWDERED)
K990883 · LZA
La Glove (M) Sdn. Bhd.
General Hospital · 147d
Cleared Aug 10, 1999
FOTONA NOVALIS ER: YAG LASER SYSTEM
K991632 · GEX
Fotona D.D.
General & Plastic Surgery · 90d
Cleared Aug 10, 1999
FOTONA NOVALIS R RUBY LASER SYSTEM
K991634 · GEX
Fotona D.D.
General & Plastic Surgery · 90d
Cleared Aug 10, 1999
HDL CHOLESTEROL, PRODUCT NO'S 124-01, CH102-01
K991665 · LBS
A.P. Total Care, Inc.
Chemistry · 88d
Cleared Aug 10, 1999
MACH-SIGMA HANDPIECE, ULTRAPUSH, MODELS MACH-SIGMA MU (MINI HEAD), MACH-SIGMA...
K991701 · EFB
Nsk Nakanishi, Inc.
Dental · 83d
Cleared Aug 10, 1999
CARESIDE MG
K991717 · JGJ
Careside, Inc.
Chemistry · 82d
Cleared Aug 10, 1999
ECG-GATING SYSTEM FOR AQUILION CT SCANNER, TSX-101A
K991766 · JAK
Toshiba America Medical Systems, In.C
Radiology · 78d
Cleared Aug 10, 1999
PLANMED SOPHIE AND SOPHIE CLASSIC
K991826 · IZH
Planmed OY
Radiology · 74d
Cleared Aug 10, 1999
CAPHOSOL ARTIFICIAL SALIVA
K991938 · LFD
Inpharma A.S.
Dental · 62d