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
64513–64536 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 26, 2005
SURGICAL FACE MASK
K050689 · FXX
China Surgical Dressings Center Co.,...
General Hospital · 223d
Cleared Oct 26, 2005
GII SPINAL FIXATION SYSTEM
K051089 · MNH
Co-Ligne AG
Orthopedic · 181d
Cleared Oct 26, 2005
GLOBAL RESURFACING UNICOMPARTMENTAL KNEE SYSTEM
K051721 · HRY
Global Orthopaedic Technology, USA, Inc.
Orthopedic · 121d
Cleared Oct 26, 2005
AIMSTICK URINE REAGENT STRIPS
K051727 · CEN
Germaine Laboratories, Inc.
Chemistry · 120d
Cleared Oct 26, 2005
FUTURAPRESS LT, N AND HP, FUTURAJET, FUTURASELF, FUTURAGEN AND FUTURACRYL 2000
K052073 · EBI
Schutz-Dental GmbH
Dental · 86d
Cleared Oct 26, 2005
SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS
K052346 · LON
Dade Behring, Inc.
Microbiology · 58d
Cleared Oct 26, 2005
RAVE COMPOSITE BRACKET
K052714 · DYW
FDA Agents
Dental · 27d
Cleared Oct 26, 2005
INFRARED THERMOMETER, FDIR-V1
K052849 · FLL
Famidoc Technology Co., Ltd.
General Hospital · 15d
Cleared Oct 26, 2005
MODEL DFP-8000D/FPD DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTOR
K052884 · OWB
Toshiba America Medical Systems, In.C
Radiology · 13d
Cleared Oct 25, 2005
SURE-SCREEN AMPHETAMINE, BENZODIAZEPINE, COCAINE, METHAMPHETAMINE/MDMA,...
K050394 · DKZ
Medtox Diagnostics, Inc.
Chemistry · 251d
Cleared Oct 25, 2005
GYRUS PLASMACISION AND PLASMABLEND ELECTRODES
K050460 · GEI
Gyrus Medical, Inc.
General & Plastic Surgery · 244d
Cleared Oct 25, 2005
SENTINEL CLIN CHEM CAL
K051452 · JIX
Sentinel Ch. Srl
Chemistry · 145d
Cleared Oct 25, 2005
TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460,...
K051587 · BTO
Tracoe Medical GmbH
Anesthesiology · 132d
Cleared Oct 25, 2005
OCT (OSTEOCHONDRAL TRANSPLANT) COMPREHENSIVE SYSTEM
K051656 · HRX
Osteobiologics, Inc.
Orthopedic · 126d
Cleared Oct 25, 2005
ARCHITECT CA 19-9XR ASSAY
K052000 · NIG
Fujirebio Diagnostics,Inc.
Immunology · 92d
Cleared Oct 25, 2005
COLLAGEN BONE HEALING PROTECTIVE SHEET
K052041 · HRS
Collagen Matrix, Inc.
Orthopedic · 89d
Cleared Oct 25, 2005
PERIPRO PATCH
K052416 · DXZ
Hancock/Jaffe Laboratories
Cardiovascular · 53d
Cleared Oct 25, 2005
HERACERAM ZIRKONIA
K052543 · EIH
Heraeus Kulzer, Inc.
Dental · 40d
Cleared Oct 25, 2005
AQUAMANTYS PUMP GENERATOR SYSTEM
K052859 · GEI
Tissuelink Medical, Inc.
General & Plastic Surgery · 14d
Cleared Oct 25, 2005
ATRICURE TRANSPOLAR SYSTEM
K052893 · GEI
AtriCure, Inc.
General & Plastic Surgery · 11d
Cleared Oct 24, 2005
ALUMA SKIN RENEWAL SYSTEM
K051214 · GEI
Lumenis, Inc.
General & Plastic Surgery · 165d
Cleared Oct 24, 2005
IRRADIA MID - LASER (S3)
K051548 · ILY
Irradia AB
Physical Medicine · 133d
Cleared Oct 24, 2005
SIMULIX-EVOLUTION WITH ONCENTRA CONEBEAM
K052361 · KPQ
Nucletron Corporation
Radiology · 56d
Cleared Oct 24, 2005
INOGEN SATELLITE CONSERVER, MODEL SC-100
K052563 · NFB
Medical Electronic Devices, Inc.
Anesthesiology · 35d