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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
31873–31896 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 14, 2016
Megapulse III Shortwave Diathermy
K153456 · IMJ
Accelerated Care Plus
Physical Medicine · 196d
Cleared Jun 14, 2016
Airborne Phototherapy Light
K160238 · LBI
International Biomedical
General Hospital · 134d
Cleared Jun 14, 2016
Disposable Hot Biopsy Forceps
K160625 · KGE
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 102d
Cleared Jun 14, 2016
Symphony Patient Transport System, Symphony Patient Trolley, Symphony...
K160627 · IYE
Qfix
Radiology · 99d
Cleared Jun 14, 2016
ally Warming Liquid Personal Lubricant
K160717 · NUC
Private Label Production, LLC
Obstetrics & Gynecology · 91d
Cleared Jun 14, 2016
Symphion Endoscope and Symphion Cervical Sheath
K160751 · HIH
Boston Scientific
Obstetrics & Gynecology · 88d
Cleared Jun 14, 2016
Full Automatic (NIBP) Blood Pressure Monitor
K161156 · DXN
Health & Life Co., Ltd.
Cardiovascular · 50d
Cleared Jun 14, 2016
ASAHI Corsair Armet
K161362 · DQY
Asahi Intecc Co., Ltd.
Cardiovascular · 29d
Cleared Jun 14, 2016
ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)
K161366 · JWH
Conformis, Inc.
Orthopedic · 28d
Cleared Jun 13, 2016
M3290B Philips IntelliVue Information Center iX
K153702 · MHX
Philips Medical Systems
Cardiovascular · 173d
Cleared Jun 13, 2016
Arrow Quickflash Arterial Catheterization Device
K160018 · DQX
Arrow International, Inc. (Subsidiary...
Cardiovascular · 160d
Cleared Jun 13, 2016
Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5
K160729 · PMT
Roche Diagnostics
Microbiology · 89d
Cleared CT Jun 13, 2016
illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma...
K160829 · OZX
Meridian Bioscience, Inc.
Microbiology · 80d
Cleared Jun 13, 2016
Medline Singe Patient Use Blood Pressure Cuff
K161035 · DXQ
Medline Industries, Inc.
Cardiovascular · 61d
Cleared Jun 13, 2016
NR Recorder
K161062 · MWJ
Norav Medical GmbH
Cardiovascular · 59d
Cleared Jun 12, 2016
Cranial COVER
K160739 · GXR
Neos Surgery S.L
Neurology · 87d
Cleared Jun 12, 2016
Penumbra System ACE 68 Reperfusion Catheter
K161064 · NRY
Penumbra, Inc.
Neurology · 58d
Cleared Jun 10, 2016
Endobronchial Tube
K152251 · CBI
Henan Tuoren Medical Device Co., Ltd.
Anesthesiology · 305d
Cleared Jun 10, 2016
DIEGO ELITE DRILL
K152744 · ERL
Gyrus Acmi, Inc.
Ear, Nose, Throat · 261d
Cleared Jun 10, 2016
DSG Threaded Drill System
K152747 · PDQ
Spineguard S.A.
Neurology · 261d
Cleared Jun 10, 2016
Pall-Aquasafe Water Filter
K153434 · NHV
Pall International Sarl
Gastroenterology & Urology · 196d
Cleared Jun 10, 2016
MaxO2ME
K153659 · CCL
Maxtec, LLC
Anesthesiology · 172d
Cleared Jun 10, 2016
Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science...
K160095 · FRO
Simple Science, LLC
General & Plastic Surgery · 143d
Cleared Jun 10, 2016
VersaWrap Tendon Protector
K160364 · OWW
Alafair Biosciences, Inc.
Orthopedic · 122d