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

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176,076 results
65977–66000 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 12, 2005
ESSENPACS
K051081 · LLZ
Cymed Engineering, Inc.
Radiology · 15d
Cleared May 12, 2005
ACUMED SCAPULA CONGRUENT BONE PLATE SYSTEM
K051083 · HRS
Acumed, LLC
Orthopedic · 15d
Cleared May 11, 2005
ACECIDE HIGH-LEVEL DISINFECTANT AND STERILANT
K041984 · MED
Best Sanitizers, Inc.
General Hospital · 292d
Cleared May 11, 2005
WILSON-COOK ENTERAL FEEDING TUBE, TIGER TUBE ENTERAL FEEDING TUBE
K043203 · KNT
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 174d
Cleared May 11, 2005
RADIOPAQUE BONE CEMENT
K043518 · NDN
Cardinalhealth
Orthopedic · 142d
Cleared May 11, 2005
MEDISPO (POWDERED) AND MEDISPO-PF (POWDER-FREE) SURGEONS GLOVE
K050071 · KGO
H.B.M. USA Co.,Inc.
General Hospital · 119d
Cleared May 11, 2005
AC-1 ADAPTER CABLE, 8 PIN AND 12 PIN PHILIPS
K050252 · DQA
Masimo Corporation
Anesthesiology · 97d
Cleared May 11, 2005
ULTRACARE DISPOSABLE PEN NEEDLES, MODELS 31 GAUGE X3/16, 29 GAUGE X 1/2
K050464 · FMI
Ultimed, Inc.
General Hospital · 77d
Cleared May 11, 2005
ALUMINA HEAD
K050556 · LZO
Fournitures Hospitalieres Industrie
Orthopedic · 69d
Cleared May 11, 2005
NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING...
K050720 · GWM
Integra Neurosciences
Neurology · 51d
Cleared May 11, 2005
HALLMARKTM ANTERIOR CERVICAL PLATE SYSTEM
K050892 · KWQ
Blackstone Medical, Inc.
Orthopedic · 33d
Cleared May 11, 2005
CZR PRESS LF STAINS
K050920 · EIH
Noritake Co., Inc.
Dental · 29d
Cleared May 11, 2005
TRABECULAR METAL ACETABULAR REVISION SHELLS
K050937 · LPH
Zimmer Trabecular
Orthopedic · 27d
Cleared May 11, 2005
DELTON ILLUMINATING PIT AND FISSURE SEALING
K050959 · EBC
Dentsply International
Dental · 23d
Cleared May 11, 2005
MODIFICATION TO: MICROLIFE DIGITAL PACIFIER THERMOMETER, MODEL MT1751Q
K051100 · FLL
Microlife Intellectual Property GmbH
General Hospital · 12d
Cleared May 10, 2005
PIONEER U121 SERIES CPAP
K041823 · BZD
Merits Health Products Co., Ltd.
Anesthesiology · 308d
Cleared May 10, 2005
MARINA MEDICAL FINGER PROTECTORS
K042534 · KGO
Marina Medical Instruments, Inc.
General Hospital · 235d
Cleared May 10, 2005
LASIK EYE DRAPE
K042977 · KKX
Odyssey Medical, Inc.
General Hospital · 194d
Cleared May 10, 2005
FOR SURE ONE STEP BUPRENORPHINE TEST STRIP
K042990 · DJG
Tianjin New Bay Bioresearch Co., Ltd.
Chemistry · 193d
Cleared May 10, 2005
ABL800 FLEX WITH FLEXQ MODULE, MODEL ABL8XX
K043218 · CHL
Radiometer Medical Aps
Chemistry · 169d
Cleared May 10, 2005
PAINPUMP2
K043466 · FRN
Stryker Instruments
General Hospital · 146d
Cleared May 10, 2005
CARDIOMPO TEST
K050029 · NTV
Prognostix, Inc.
Chemistry · 124d
Cleared May 10, 2005
RESSCAN
K050775 · BZD
Resmed, Ltd.
Anesthesiology · 43d
Cleared May 10, 2005
PAINACEA MODEL XR8 INFRARED HEAT LAMP
K051046 · ILY
Atlantis Luminescent Products, LLC
Physical Medicine · 15d