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
43321–43344 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 11, 2012
ABUTMENT FOR COMPETITIVE IMPLANT NOBEL ACTIVE CONNECTION
K120776 · NHA
Biomet 3i
Dental · 181d
Cleared Sep 11, 2012
UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN ALC-(HBA1C-) REAGENT
K121492 · LCP
Beckman Coulter, Inc.
Chemistry · 113d
Cleared Sep 11, 2012
POWER-FREE NITRILE EXAMINATION GLOVES, PEPPERMINT SCENTED, BLUE COLOR
K121528 · LZA
Shen Wei (Usa), Inc.
General Hospital · 111d
Cleared Sep 11, 2012
RANGE SPINAL SYSTEM
K121630 · OSH
K2m, Inc.
Orthopedic · 99d
Cleared Sep 11, 2012
QUINTEX CERVICAL PLATING SYSTEM
K121801 · KWQ
Aesculap Implant Systems, LLC
Orthopedic · 84d
Cleared Sep 11, 2012
NUVASIVE PRECEPT SPINAL SYSTEM
K122352 · NKB
Nuvasive, Inc.
Orthopedic · 39d
Cleared Sep 11, 2012
VOLUSON P6, VOLUSON P8
K122387 · IYN
Ge Healthcare
Radiology · 36d
Cleared Sep 11, 2012
ROTH NET RETRIEVER
K122462 · FDI
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 29d
Cleared Sep 11, 2012
SOMATOM DEFINITION
K122471 · JAK
Siemens Medical Systems, Inc.
Radiology · 28d
Cleared Sep 11, 2012
C2-9-D ULTRASOUND TRANSDUCER
K122515 · ITX
Ge Healthcare
Radiology · 25d
Cleared Sep 10, 2012
ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4...
K112624 · OIU
Roche Diagnostics
Immunology · 368d
Cleared Sep 10, 2012
UNITY TOATAL KNEE SYSTEM
K113060 · JWH
Corin USA
Orthopedic · 332d
Cleared Sep 10, 2012
ESENSOR RESPIRATORY VIRAL PANEL
K113731 · JJH
Clinical Micro Sensors, Inc.
Microbiology · 266d
Cleared Sep 10, 2012
BAROSENSE ENDOGASTRIC TUBE AND INTRODUCER BOUGIE
K120126 · FED
Barosense, Inc.
Gastroenterology & Urology · 237d
Cleared Sep 10, 2012
BENCOX MIRABO CUP BENCOX MIRABO INSERT (STANDARD& ELEVATED TYES) BENCOX...
K120924 · LPH
Corentec Co., Ltd.
Orthopedic · 167d
Cleared Sep 10, 2012
VISIONS PV .035 DITITAL IVUS CATHETER
K121273 · OBJ
Volcano Corporation
Cardiovascular · 136d
Cleared Sep 10, 2012
LANX SPINAL FIZATION SYSTEM
K121316 · NKB
Lanx, Inc.
Orthopedic · 131d
Cleared Sep 10, 2012
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K121372 · DXN
Andon Health Co, Ltd.
Cardiovascular · 126d
Cleared Sep 10, 2012
INTEGRA CAMINO ICP MONITOR
K121573 · GWM
Intrgra Lifesciences Corporation
Neurology · 104d
Cleared Sep 10, 2012
DELICOT
K121822 · HBA
American Surgical Company, LLC
Neurology · 81d
Cleared Sep 10, 2012
EARLYSENSE CENTRAL DISPLAY SYSTEM
K121885 · MSX
Earlysense, Ltd.
Cardiovascular · 74d
Cleared Sep 10, 2012
TAPERSET HIP SMALL STEMS
K121935 · LPH
Consensus Orthopedics, Inc.
Orthopedic · 70d
Cleared Sep 10, 2012
ETS BLUE POWDER-FREE PATIENT NITRILE EXAMINATION GLOVES
K121947 · LZA
Northstar Healthcare Holdings
General Hospital · 69d
Cleared Sep 10, 2012
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
K122363 · LZA
Siam Sempermed Corp., Ltd.
General Hospital · 35d