Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
81457–81480 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 24, 2000
CYTOPLAST SUTURE
K003028 · NBY
Osteogenics Biomedical, Inc.
General & Plastic Surgery · 57d
Cleared Nov 24, 2000
IMAGE VASCULAR LASER
K003046 · GEX
Sciton, Inc
General & Plastic Surgery · 56d
Cleared Nov 24, 2000
VERSALINK TITANIUM ROD-TO-ROD COUPLERS
K003384 · MNH
Osteotech, Inc.
Orthopedic · 24d
Cleared Nov 24, 2000
ALUMINA V40 HEAD
K003413 · LZO
Howmedica Osteonics Corp.
Orthopedic · 22d
Cleared Nov 24, 2000
ISS OFFSET HEADS
K003428 · HSD
Biomet, Inc.
Orthopedic · 21d
Cleared Nov 22, 2000
PC ECG 1200
K000404 · MWI
Norav Medical , Ltd.
Cardiovascular · 289d
Cleared Nov 22, 2000
ALPHA OMEGA DUAL COOLER-HEATER
K001520 · DWC
Alpha Omega, Inc.
Cardiovascular · 190d
Cleared Nov 22, 2000
SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET
K001563 · FGO
Scion Cardiovascular, Inc.
Gastroenterology & Urology · 187d
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