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
38737–38760 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 13, 2014
OMNI ARC MONOBLOCK HIP STEM
K133381 · LZO
Omnilife Science
Orthopedic · 129d
Cleared Mar 13, 2014
MALLEABLE SUCTION INSTRUMENTS
K133665 · PGW
Medtronic Navigation, Inc.
Ear, Nose, Throat · 104d
Cleared Mar 13, 2014
CHLORASHIELD IV DRESSING WITH CHG ANTIMICROBIAL
K133764 · FRO
Avery Dennison Belgie Bvba
General & Plastic Surgery · 92d
Cleared Mar 13, 2014
KLASSIC HD HIP SYSTEM, OFFSET FEMORAL STEM, NON-POROUS / POROUS
K133832 · LPH
Total Joint Orthopedics, Inc.
Orthopedic · 86d
Cleared Mar 13, 2014
EMERGE MEDICAL DISTAL RADIUS SET
K140107 · HRS
Emerge Medical
Orthopedic · 57d
Cleared Mar 13, 2014
CD HORIZON SPINAL SYSTEM
K140276 · OSH
Medtronic Sofamor Danek
Orthopedic · 38d
Cleared Mar 12, 2014
FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM
K130981 · FGE
Cordis Corp.
Gastroenterology & Urology · 337d
Cleared Mar 12, 2014
BODIHEALTH SYSTEM
K131675 · GZJ
Eprt Technologies, Inc.
Neurology · 278d
Cleared Mar 12, 2014
SNAP WOUND CARE SYSTEM
K132080 · OKO
Spiracur, Inc.
General & Plastic Surgery · 250d
Cleared Mar 12, 2014
STELLARIS PC VISION ENHANCEMENT SYSTEM
K133486 · HQC
Bausch & Lomb
Ophthalmic · 119d
Cleared Mar 12, 2014
POLARIS SPINAL SYSTEM
K133746 · NKB
Biomet Spine (Aka Ebi, LLC)
Orthopedic · 93d
Cleared Mar 12, 2014
SURGISLEEVE WOUND PROTECTOR
K140064 · KKX
Covidien
General Hospital · 61d
Cleared Mar 12, 2014
EMERGE MEDICAL SMALL FRAGMENT LOCKED PLATING SYSTEM
K140098 · HRS
Emerge Medical
Orthopedic · 57d
Cleared Mar 12, 2014
EMERGE MEDICAL PERIARTICULAR AND LOCKING LARGE FRAGMENT SYSTEM
K140119 · HRS
Emerge Medical
Orthopedic · 55d
Cleared Mar 12, 2014
SOUNDSTAR ECO 8F GULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER
K140318 · OBJ
Biosense Webster
Cardiovascular · 30d
Cleared Mar 12, 2014
TORRENT IRRIGATION SYSTEM
K140405 · OCX
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 22d
Cleared Mar 11, 2014
NOVEON
K122358 · GEX
Hogan Lovells US LLP
General & Plastic Surgery · 585d
Cleared Mar 11, 2014
ISYS 1 (U.S),ACCESSORY, NON-STERILE
K131433 · JAK
Isys Medizintechnik GmbH
Radiology · 298d
Cleared Mar 11, 2014
BPROSOFT CASP PC SOFTWARE
K131916 · DXN
Healthstats International Pte. , Ltd.
Cardiovascular · 258d
Cleared Mar 11, 2014
CIOS ALPHA
K132094 · OWB
Siemens Medi Cal Solutions, Inc.
Radiology · 246d
Cleared Mar 11, 2014
NEWTRON P5 XS B.LED
K132322 · ELC
Satelec - Acteon Group
Dental · 229d
Cleared Mar 11, 2014
ACCURO 3000 ULTRASOUND SCANNER
K132736 · IYO
Rivanna Medical, LLC
Radiology · 189d
Cleared Mar 11, 2014
REVERE STABILIZATION SYSTEM
K133350 · NKB
Globus Medical, Inc.
Orthopedic · 132d
Cleared Mar 11, 2014
OVATION TRIBUTE HIP STEM
K133386 · LPH
Ortho Development Corp.
Orthopedic · 126d