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
80857–80880 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 22, 2000
CODA INCUBATOR CELLMATE
K001600 · MQG
Intl., Inc.
Obstetrics & Gynecology · 182d
Cleared Nov 22, 2000
COMFIT CHEMO PLUS PLUS POWDER FREE NITRILE EXAMINATION GLOVES (TESTED FOR USE...
K001613 · LZA
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 181d
Cleared Nov 22, 2000
BIO-RAD %CDT TIA
K001651 · JJX
Axis-Shield Biochemicals, Asa
Chemistry · 176d
Cleared Nov 22, 2000
T.I.M.S., VERSION 2.00
K001947 · LLZ
Total Medical Information Management...
Radiology · 149d
Cleared Nov 22, 2000
PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM...
K002024 · GRY
Panbio, Inc.
Microbiology · 142d
Cleared Nov 22, 2000
DRG PURETONE STETHOSCOPE WITH DRG ANTIMICROBIAL, STETHOSCOPE DIAPHRAGM, MODEL...
K002047 · DQD
Doctor'S Research Group, Inc.
Cardiovascular · 139d
Cleared Nov 22, 2000
BRANAN MEDICAL CORPORATION MONITECT AMPHETAMINE DRUG SCREEN TEST
K002266 · DKZ
Branan Medical Corporation
Toxicology · 120d
Cleared Nov 22, 2000
BRANAN MEDICAL CORPORATION MONITECT PCP DRUG SCREEN TEST, MODEL 160C AND 160D
K002272 · LCM
Branan Medical Corp.
Toxicology · 119d
Cleared Nov 22, 2000
BRANAN MEDICAL CORPORATION MONITECT BARBITURATES DRUG SCREEN TEST
K002337 · DIS
Branan Medical Corporation
Toxicology · 113d
Cleared Nov 22, 2000
BRANAN MEDICAL CORPORATION MONITECT METHADONE DRUG SCREEN TEST, MODEL 190C...
K002417 · DJR
Branan Medical Corporation
Toxicology · 106d
Cleared Nov 22, 2000
BRANAN MEDICAL CORPORATION MONITECT MORPHINE 300 DRUG SCREEN TEST, MODEL 133C...
K002418 · DOE
Branan Medical Corporation
Toxicology · 106d
Cleared Nov 22, 2000
BRANAN MEDICAL CORPORATION MONITECT METHAMPHETAMINE 500 DRUG SCREEN TEST
K002587 · DJC
Branan Medical Corporation
Toxicology · 93d
Cleared Nov 22, 2000
EMERSON COUGH ASSIST MODEL CA-3000 W/AUTOMATIC TIMING AND MODEL CM-3000...
K002598 · NHJ
J. H. Emerson Co.
Anesthesiology · 93d
Cleared Nov 22, 2000
VYPRO MESH, VICRYL PROLENE PARTIALLY ABSORBABLE SYNTHETIC SURGICAL MESH
K002672 · FTL
Ethicon, Inc.
General & Plastic Surgery · 86d
Cleared Nov 22, 2000
WMT ULTRA-FIT MODULAR SHOULDER SYSTEM
K002683 · KWS
Wrightmedicaltechnologyinc
Orthopedic · 86d
Cleared Nov 22, 2000
ENTERIC INJECTION CATHETER WITH IRRIGATION
K002778 · FBK
Enteric Medical Technologies, Inc.
Gastroenterology & Urology · 77d
Cleared Nov 22, 2000
TRANSONIC HEMODIALYSIS FLOW REVERSER, MODEL B FLOWREV
K002816 · KOC
Transonic Systems, Inc.
Gastroenterology & Urology · 72d
Cleared Nov 22, 2000
MODEL 6900GE-64: C-SPINE ARRAY
K002860 · MOS
Midwest Rf, LLC
Radiology · 70d
Cleared Nov 22, 2000
GIMBEL PUNCTURE RESISTANT LATEX SURGICAL GLOVE WITH PUNCTURE RESISTANCE...
K003063 · KGO
Gimbel Glove Co., LLC
General Hospital · 51d
Cleared Nov 22, 2000
MICROMANIPULATOR
K003142 · MQJ
Research Instruments , Ltd.
Obstetrics & Gynecology · 43d
Cleared Nov 22, 2000
VINYL, POWDER-FREE, PATIENT EXAMINATION GLOVES, YELLOW
K003197 · LYZ
Kaohsiung Brothers Products Corp.
General Hospital · 41d
Cleared Nov 22, 2000
MO-202D THREE-AXIS HANGING JOYSTICK OIL HYDRAULIC MICROMANIPATOR
K003300 · MQJ
Narishige Co., Ltd.
Obstetrics & Gynecology · 33d
Cleared Nov 22, 2000
IM-5A INJECTOR
K003302 · MQJ
Narishige Co., Ltd.
Obstetrics & Gynecology · 33d
Cleared Nov 22, 2000
IM-5B MICROINJECTOR
K003303 · MQJ
Narishige Co., Ltd.
Obstetrics & Gynecology · 33d