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
74905–74928 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 30, 2002
WU'S 4-WHEELED NEO SCOOTER, WT-L4
K013763 · INI
Wu'S Tech Co., Ltd.
Physical Medicine · 259d
Cleared Jul 30, 2002
EPOCH HIP PROSTHESIS, MODEL 4075 SERIES
K014070 · LPH
Zimmer, Inc.
Orthopedic · 232d
Cleared Jul 30, 2002
HYCARE LATEX EXAMINATION GLOVE, POWDER FREE
K020042 · LYY
Hycare Intl. Co., Ltd.
General Hospital · 204d
Cleared Jul 30, 2002
SELICOR, MODELS A100 & D100
K020227 · IMJ
Selicor, Inc.
Physical Medicine · 189d
Cleared Jul 30, 2002
HI-OX
K020665 · CBP
Sensor Medics Corp.
Anesthesiology · 151d
Cleared Jul 30, 2002
WA RUBBERMATE LATEX POWDER-FREE EXAM GLOVES
K021041 · LYY
W.A. Rubbermate Co., Ltd.
General Hospital · 120d
Cleared Jul 30, 2002
NMP22 BLADDERCHEK KIT, NMP22 CONTROL KIT
K021231 · MMW
Matritech, Inc.
Immunology · 103d
Cleared Jul 30, 2002
TRZ-CG POWER POSITIONING SYSTEM WITH CENTER-OF-GRAVITY SHIFTING POWER TILT,...
K021264 · ITI
Motion Concepts
Physical Medicine · 99d
Cleared Jul 30, 2002
TTECH MODEL 200E + TENS DEVICE
K021436 · GZJ
Theratech, Inc.
Neurology · 85d
Cleared Jul 30, 2002
OEMEDIC INTERNATIONAL INC. BESMED SINGLE USE ADULT, CHILD, INFANT MANUAL...
K021442 · BTM
Oemedic International, Inc.
Anesthesiology · 85d
Cleared Jul 30, 2002
QUANTA LITE SLA (SOLUBLE LIVER ANTIGEN) ELISA
K021482 · NIY
Inova Diagnostics, Inc.
Immunology · 83d
Cleared Jul 30, 2002
CHROLOY
K021969 · EJH
Neirynck & Vogt NV
Dental · 43d
Cleared Jul 30, 2002
QUINCKE SPINAL NEEDLE
K022029 · BSP
Epimed International, Inc.
Anesthesiology · 39d
Cleared Jul 30, 2002
PROVOX FREEHANDS HME, MODEL 7710
K022125 · EWL
Atos Medical AB
Ear, Nose, Throat · 29d
Cleared Jul 30, 2002
VERDICT-II
K022141 · DJC
Medtox Diagnostics, Inc.
Toxicology · 28d
Cleared Jul 30, 2002
MODIFICATION TO EN-BLOC BIOPSY SYSTEM
K022296 · GEI
Neothermia Corp.
General & Plastic Surgery · 14d
Cleared Jul 30, 2002
PHILIPS M2424 DIAGNOSTIC ULTRASOUND SYSTEM &PHILIPS 21315 DIAGNOSTIC...
K022303 · IYN
Philips Ultrasound, Inc.
Radiology · 14d
Cleared Jul 30, 2002
QUICKTOX MULTIPLE DRUG DIPCARD COC/MET/THC/AMP/PCP/BZO/BAR/MTD/TCA, MODEL QT61
K022355 · DIO
Branan Medical Corp.
Toxicology · 11d
Cleared Jul 29, 2002
REPROCESSED TROCARS AND CANNULAS
K012644 · NLM
Surgical Instruments Service and...
Gastroenterology & Urology · 350d
Cleared Jul 29, 2002
FRED HUTCHINSON CANCER RESEARCH CENTER ENZYME ANTI-SR PROTEIN ANTIBODY TEST
K013263 · LKP
Fred Hutchinson Cancer Research Center
Immunology · 301d
Cleared Jul 29, 2002
WISORB MALLEOLAR SCREW
K020222 · HWC
Cambridge Scientific, Inc.
Orthopedic · 188d
Cleared Jul 29, 2002
READI-STRAND
K020337 · KXK
Worldwide Medical Technologies, LLC
Radiology · 178d
Cleared Jul 29, 2002
MICROPLEX COIL SYSTEM (MCS)
K020434 · HCG
MicroVention, Inc.
Neurology · 171d
Cleared Jul 29, 2002
ACCULASER PRO LOW LEVEL LASER THERAPY DEVICE
K020657 · NHN
Acculaser, Inc.
Physical Medicine · 151d