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
143377–143400 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 27, 1986
RICH-MAR SPINA-MOBILIZOR
K861832 · ITH
Rich-Mar Corp.
Physical Medicine · 45d
Cleared Jun 27, 1986
WORTHINGTON HDL PRECIPITATING REAGENT SET
K861926 · LBR
Cooper Biomedical, Inc.
Chemistry · 39d
Cleared Jun 27, 1986
DERMISTRIP
K861972 · NAD
Kells Medical, Inc.
General & Plastic Surgery · 37d
Cleared Jun 27, 1986
TOTAL BILIRUBIN TEST KIT
K861998 · CIG
Ciba Corning Diagnostics Corp.
Chemistry · 35d
Cleared Jun 27, 1986
MEDISYSTEMS PHERESIS NEEDLE
K862002 · FIE
Medisystems Corp.
Gastroenterology & Urology · 35d
Cleared Jun 27, 1986
STAND & HIGH FLOW FEMORAL-VENTRICULAR PIGTAIL CATH
K862006 · DQO
Cordis Corp.
Cardiovascular · 31d
Cleared Jun 27, 1986
POLYPECTOMY SNARE
K862060 · KNS
Endovations
Gastroenterology & Urology · 28d
Cleared Jun 27, 1986
ARIZONA CONDYLAR TIBIAL PLATEAU
K862125 · HRY
Depuy, Inc.
Orthopedic · 24d
Cleared Jun 27, 1986
RAICHEM CHOLINESTERASE REAGENT
K862168 · DIH
Reagents Applications, Inc.
Toxicology · 18d
Cleared Jun 27, 1986
EMIT QUINIDINE ASSAY
K862214 · LBZ
Syva Co.
Toxicology · 17d
Cleared Jun 27, 1986
DOUBLE ANTIBODY COCAINE METABOLITE RIA KIT
K862218 · KLN
Diagnostic Products Corp.
Chemistry · 16d
Cleared Jun 27, 1986
TSH IRMA KIT
K862249 · JLW
Pacific Biotech, Inc.
Chemistry · 15d
Cleared Jun 26, 1986
FAST FORMALERT
K853555 · KOC
Organon Teknika Corp.
Gastroenterology & Urology · 304d
Cleared Jun 26, 1986
ORG-7201 MULTIPARAMETER TELEMETRY MONITOR
K860239 · DRG
Nihon Kohden America, Inc.
Cardiovascular · 154d
Cleared Jun 26, 1986
SCHERER PORTABLE TOOTH POLISHER
K860264 · JEQ
Scherer Laboratories, Inc.
Dental · 150d
Cleared Jun 26, 1986
OXYGENATOR MODEL NOS. BENTLEY-10A & BENTLEY-10B
K860673 · DTZ
American Bentley
Cardiovascular · 122d
Cleared Jun 26, 1986
CORDIS HI-FLEX PERVENOUS BIPOLAR LEAD
K860846 · DTB
Cordis Corp.
Cardiovascular · 112d
Cleared Jun 26, 1986
PACESETTER/SIEMENS PULSE GENERA W/VS-1 HEAD CAVITY
K861422 · DXY
Pacesetter Systems
Cardiovascular · 71d
Cleared Jun 26, 1986
SUCTION CONTROL VALVE (NONADJUSTABLE) CAT.RLV-2100
K861428 · DWD
American Omni Medical, Inc.
Cardiovascular · 71d
Cleared Jun 26, 1986
EOH 8501 OSSEOINTEGRATED IMPLANT SYSTEM
K861502 · DZE
Dr. Harold Bergman
Dental · 64d
Cleared Jun 26, 1986
HYDRON ROOT CANAL FILLING & MARK IV STARTER KIT
K861846 · EIC
Solar Dental Co., Inc.
Dental · 44d
Cleared Jun 26, 1986
JELTRODE
K861956 · GXY
Henley Intl.
Neurology · 37d
Cleared Jun 26, 1986
MODEL CA, HEARING AID
K862095 · ESD
Fine-Tune
Ear, Nose, Throat · 24d
Cleared Jun 26, 1986
PAP SMEAR KIT
K862242 · HHT
Quali-Med, Inc.
Obstetrics & Gynecology · 14d