FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
105049–105072 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 23, 1995
COAT-A-COUNT(R) ESTRADIOL-6
K943193 · CHP
Diagnostic Products Corp.
Chemistry · 233d
Cleared Feb 23, 1995
IMMULITE(R) ALLERGY FOOD PANEL FP5E
K943194 · DGO
Diagnostic Products Corp.
Immunology · 233d
Cleared Feb 23, 1995
FUKUDA SANGYO MODEL SPIROANALYZER ST-180
K943546 · BZG
Spirosoft Northamerica, Inc.
Anesthesiology · 217d
Cleared Feb 23, 1995
LAPRASCOPIC GRASPER
K944062 · GCS
Instrument Makar, Inc.
Gastroenterology & Urology · 188d
Cleared Feb 23, 1995
VISITEC SCLERAL PLUG
K945114 · LXP
Visitec Co.
Ophthalmic · 128d
Cleared Feb 23, 1995
OPTUS LAPAROSCOPES AND OPERATING LAPAROSCOPES
K945266 · GCJ
Optus, Inc.
General & Plastic Surgery · 118d
Cleared Feb 23, 1995
ENDCUP
K945862 · GCJ
Lewtek
General & Plastic Surgery · 84d
Cleared Feb 23, 1995
HICHEM LDH/L REAGENT KIT
K946022 · CFJ
Hichem Diagnostics
Chemistry · 73d
Cleared Feb 23, 1995
LEVEEN NEEDLE ELECTRODE(TM)
K950347 · GEI
Radiotherapeutics Corp.
General & Plastic Surgery · 27d
Cleared Feb 23, 1995
BASIC REUSABLE TROCAR SYSTEM
K950500 · GCJ
Endoscopic Concepts, Inc.
General & Plastic Surgery · 17d
Cleared Feb 22, 1995
EMIT IIC BARBITURATE ASSAY
K935116 · DIS
Syva Co.
Toxicology · 483d
Cleared Feb 22, 1995
EMIT IIC PHENCYCLIDINE ASSAY
K935191 · LCM
Syva Co.
Toxicology · 484d
Cleared Feb 22, 1995
EMIT IIC COCAINE METABOLITE ASSAY
K935323 · DIO
Syva Co.
Toxicology · 475d
Cleared Feb 22, 1995
EMIT(R) IIC AMPHETAMINE ASSAY
K935352 · DKZ
Syva Co.
Toxicology · 474d
Cleared Feb 22, 1995
EMIT IIC CANNABINOID ASSAY
K940158 · LDJ
Syva Co.
Toxicology · 406d
Cleared Feb 22, 1995
MIC PERCUTANEOUS ENDOSCOPIC JEJUNAL FEEDING TUBE
K940548 · KNT
Medical Innovations Corp.
Gastroenterology & Urology · 380d
Cleared Feb 22, 1995
INTERGRATED MONITORING ARCHIVING AND COMMUNICATIONS SYSTEMS (IMACS)
K941762 · DQK
Hogan & Hartson
Cardiovascular · 317d
Cleared Feb 22, 1995
NON-UNIFORM ATTENUATION CORRECTION SYSTEM
K942145 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 295d
Cleared Feb 22, 1995
ABUSIGN DOA4
K943439 · DKZ
Princeton BioMeditech Corp.
Toxicology · 219d
Cleared Feb 22, 1995
CVPRO CARDIOVASCULAR PATCH
K943736 · DXZ
W.L. Gore & Associates, Inc.
Cardiovascular · 204d
Cleared Feb 22, 1995
LIFESIGN, CARE POINT, VITALSIGN, ACCUSIGN
K944325 · JHW
Princeton BioMeditech Corp.
Chemistry · 173d
Cleared Feb 22, 1995
HANDYPACK 911SC
K944541 · CCK
Pace Tech, Inc.
Anesthesiology · 160d
Cleared Feb 22, 1995
AURA FLEX FT4 200 TEST PACK, FT4 CALIBRATOR PACK
K944697 · CEC
Organon Teknika Corp.
Chemistry · 152d
Cleared Feb 22, 1995
MICRO MINI PRIMO AGC, MICRO-MINI PRIMO S-AGC
K944851 · ESD
Rexton, Inc.
Ear, Nose, Throat · 145d