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
84937–84960 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Aug 10, 1999
RADIFOCUS OPTITORQUE
K992051 · DQO
Terumo Medical Corp.
Cardiovascular · 53d
Cleared Aug 10, 1999
LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965
K992252 · LYF
Chemicon Intl., Inc.
Microbiology · 35d
Cleared Aug 10, 1999
AIA-PACK FOLATE ASSAY
K992365 · CGN
Tosoh Medics, Inc.
Chemistry · 26d
Cleared Aug 10, 1999
ACCUSIGN DOA3,DOA, COC/THC/OPI2000 DOA3
K992422 · DJG
Princeton BioMeditech Corp.
Toxicology · 20d
Cleared Aug 10, 1999
SECHRIST AIR-OXYGEN MIXER, 3500/3500HL SERIES
K992503 · BZR
Sechrist Industries, Inc.
Anesthesiology · 14d
Cleared Aug 09, 1999
CADPLAN HELIOS OPTION 6.0
K984532 · MUJ
Varian Medical Systems, Inc.
Radiology · 231d
Cleared Aug 09, 1999
IMMUNOCARD STAT! E. COLI O157:H7
K990263 · GMZ
Meridian Diagnostics, Inc.
Microbiology · 194d
Cleared Aug 09, 1999
SAS ROTA TEST
K990842 · LIQ
Sa Scientific, Inc.
Microbiology · 147d
Cleared Aug 09, 1999
TOUCH TEAR IGE MICROASSAY KIT
K991316 · DGC
Touch Scientific, Inc.
Immunology · 112d