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
73369–73392 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 07, 2002
BLOOD/SOLUTION ADMINISTRATION SET, MODEL 33.015
K023039 · BRZ
Tuta Healthcare Pty Limited
General Hospital · 56d
Cleared Nov 07, 2002
MODIFICATION TO SYNCHRON SYSTEMS BENZODIAZEPINE REAGENT
K023048 · JXM
Beckman Coulter, Inc.
Toxicology · 55d
Cleared Nov 07, 2002
SURETAC III, MODELS 7209900, 7209901
K023417 · JDR
Smith & Nephew, Inc.
Orthopedic · 27d
Cleared Nov 07, 2002
TMD SAFETY SYRINGE (FA14 SERIES 10ML/FA15 SERIES 20ML)
K023458 · MEG
Taiject Medical Device Co., Ltd.
General Hospital · 23d
Cleared Nov 07, 2002
CENTRICITY PACS PLUS
K023557 · LLZ
GE Medical Systems
Radiology · 15d
Cleared Nov 07, 2002
ASTRA TECH DENTAL IMPLANTS-CERAMIC ABUTMENTS
K023631 · NHA
Astra Tech, Inc.
Dental · 9d
Cleared Nov 06, 2002
CO-AXIAL INTRODUCER NEEDLE
K022634 · DYB
Promex, Inc.
Cardiovascular · 90d
Cleared Nov 06, 2002
RETRO REPAIR KIT, MODEL PRRK5
K022644 · NFK
Spire Biomedical, Inc.
Gastroenterology & Urology · 90d
Cleared Nov 06, 2002
BIRD AVEA VENTILATOR
K022674 · CBK
Bird Products Corp.
Anesthesiology · 86d
Cleared Nov 06, 2002
AMEDICA DRUG SCREEN COCAINE TEST
K022954 · DIO
Amedica Biotech, Inc.
Toxicology · 62d
Cleared Nov 06, 2002
AMEDICA DRUG SCREEN THC TEST
K022955 · LDJ
Amedica Biotech, Inc.
Toxicology · 62d
Cleared Nov 06, 2002
AMEDICA DRUG SCREEN OPIATES TEST
K023047 · DJG
Amedica Biotech, Inc.
Toxicology · 55d
Cleared Nov 06, 2002
INDWELLING FECAL MANAGEMENT SYSTEM-NON-STERILE
K023344 · KNT
Bowel Management Systems, LLC
Gastroenterology & Urology · 30d
Cleared Nov 06, 2002
ESPRIT VENTILATOR WITH RESPIRATORY MECHANICS
K023350 · CBK
Respironics California, Inc.
Anesthesiology · 30d
Cleared Nov 06, 2002
ARCPM 1050 RESIN-HIPS
K023357 · LPH
Biomet Orthopedics, Inc.
Orthopedic · 30d
Cleared Nov 06, 2002
8F LAUNCHER GUIDE CATHETER
K023402 · DQY
Medtronic Vascular
Cardiovascular · 27d
Cleared Nov 06, 2002
HEARTONE EVENT RECORDER AND TRANSMITTER
K023418 · DXH
Aerotel Medical Systems (1998) , Ltd.
Cardiovascular · 26d
Cleared Nov 06, 2002
DRAPES WITH ABSORBENT REINFORCEMENT
K023425 · KKX
Allegiance Healthcare Corp.
General Hospital · 26d
Cleared Nov 06, 2002
STERI-MATE STERILIZABLE HANDPIECE
K023697 · ELC
Dentsply International
Dental · 2d
Cleared Nov 05, 2002
COZART RAPISCAN ORAL FLUID DRUG TEST - OPIATE/METHADONE
K020920 · DJG
Cozart Bioscience , Ltd.
Toxicology · 229d
Cleared Nov 05, 2002
THERMAGE THERMACOOL TC SYSTEM
K021402 · GEI
Thermage, Inc.
General & Plastic Surgery · 187d
Cleared Nov 05, 2002
SIEMENS VIRTUAL SIMULATION (VSIM)
K022036 · MUJ
Siemens Medical Solutions USA, Inc.
Radiology · 134d
Cleared Nov 05, 2002
CLARUS STRAIGHT FIRING LASER FIBER, MODEL 1150, CLARUS SIDE FIRING LASER...
K022610 · GEX
Clarus Medical, LLC
General & Plastic Surgery · 91d
Cleared Nov 05, 2002
WMT-TCP BONE GRAFT SUBSTITUTE
K022629 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 90d