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
84097–84120 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 01, 1999
IL TEST VON WILLEBRAND FACTOR
K992704 · GGP
Instrumentation Laboratory CO
Hematology · 81d
Cleared Nov 01, 1999
K-ASSAY MYOGLOBIN ASSAY, K-ASSAY MYOGLOBIN CALIBRATOR
K992976 · DDR
Kamiya Biomedical Co.
Chemistry · 59d
Cleared Nov 01, 1999
MEDICA INDIRECT IMMUNOFLUORESCENCE (IIF) ANTI- ENDOMYSIAL ANTIBODY (AEMA)...
K993034 · MVM
Medica, Inc.
Immunology · 53d
Cleared Nov 01, 1999
RAPICURE 200 (CURING AND WHITENING LIGHT)
K993223 · EBZ
Mediphotonix, LC
Dental · 35d
Cleared Nov 01, 1999
IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107K
K993387 · FRN
Baxter Healthcare Corp
General Hospital · 24d
Cleared Nov 01, 1999
HRW WRIST ARRAY COIL
K993477 · MOS
Mri Devices Corp.
Radiology · 18d
Cleared Oct 29, 1999
DR. JAHANGER'S CUTTER
K990738 · KNA
M.S. Jahanger, MD
Obstetrics & Gynecology · 238d
Cleared Oct 29, 1999
NUTRISAFE EXTENSION TUBE
K991918 · KNT
Vygon Corp.
Gastroenterology & Urology · 144d
Cleared Oct 29, 1999
MAPS 10000
K992560 · KPS
Web Link Medical
Radiology · 88d
Cleared Oct 29, 1999
OMNIPULSE HOLMIUM LASER SYSTEM MODEL 1210, OMNIPULSE-MAX HOLMIUM LASER SYSTEM...
K992574 · GEX
Trimedyne, Inc.
General & Plastic Surgery · 88d
Cleared Oct 29, 1999
MASS (MICRO-ACCESS SPINE SYSTEM)
K992583 · HRX
Omni-Tract Surgical, Div. Minn....
Orthopedic · 88d
Cleared Oct 29, 1999
KONICA LASER IMAGER, DRYPRO MODEL 722
K992586 · LMC
Konica Corp.
Radiology · 88d
Cleared Oct 29, 1999
RESPALERT
K992618 · BZH
Harwill Medical (Pty) , Ltd.
Anesthesiology · 86d
Cleared Oct 29, 1999
ATD AUTOMATIC BRIDGE REMOVER
K992649 · EIS
J. Morita USA, Inc.
Dental · 84d
Cleared Oct 29, 1999
TG MEDICAL POWDERED NITRILE BLUE EXAMINATION GLOVES
K992841 · LZA
Tg Medical Sdn. Bhd.
General Hospital · 66d
Cleared Oct 29, 1999
SURGEONS GLOVE, BROWN LATEX POLYMER COATED, POWDER FREE WITH PROTEIN LABEL CLAIM
K992953 · KGO
Ansell Perry
General Hospital · 58d
Cleared Oct 29, 1999
PALMAZ XL TANSHEPATIC BILIARY STENTS
K993091 · FGE
Cordis Corp.
Gastroenterology & Urology · 43d
Cleared Oct 29, 1999
HEALTH-PLUS, SANITEX, RELIANCE (50 MICROGRAMS)
K993093 · LYY
Pamitex Industries Sdn Bhd
General Hospital · 43d
Cleared Oct 29, 1999
POWDER FREE (SILICON COATED) LATEX EXAMINATION GLOVES WITH PROTEIN LABELING...
K993287 · LYY
Pan-Century Rubber Products Sdn. Bhd.
General Hospital · 28d
Cleared Oct 29, 1999
QUICKSTRIP ONE STEP OPIATES TEST
K993490 · DJG
Syntron Bioresearch, Inc.
Toxicology · 14d
Cleared Oct 29, 1999
QUICKPAC II ONE STEP OPIATES TEST
K993491 · DJG
Syntron Bioresearch, Inc.
Toxicology · 14d
Cleared Oct 28, 1999
SERAQUEST EB VCA IGG
K990410 · LSE
Quest Intl., Inc.
Microbiology · 261d
Cleared Oct 28, 1999
DUAL LUMEN CATHETER, MODEL DL-35-90
K991601 · DQY
Endologix, Inc.
Cardiovascular · 171d
Cleared Oct 28, 1999
SPRING-WOUND EPIDURAL CATHETER
K991879 · BSO
Micor, Inc.
Anesthesiology · 148d