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
58897–58920 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 15, 2007
BOSTON X02 (HEXAFOCON B) RIGID GAS PERMEABLE CONTACT LENS
K071266 · HQD
Bausch & Lomb, Inc.
Ophthalmic · 100d
Cleared Aug 15, 2007
ARGEN PEARL BRAND ZIRCONIA
K071410 · EIH
The Argen Corporation
Dental · 86d
Cleared Aug 15, 2007
INOLASE SERENITY PSF ( PNEUMATIC SKIN FLATTENING) SYSTEM
K071469 · GEX
Candela Corp.
General & Plastic Surgery · 78d
Cleared Aug 15, 2007
REVERTO 55 AND 37 SHAPE MEMORY STAPLES
K071477 · JDR
Core Essence Orthopaedics, LLC
Orthopedic · 78d
Cleared Aug 15, 2007
ICATH, STERILESURE
K071496 · NWO
Colorado Catheter Company, Inc.
Gastroenterology & Urology · 76d
Cleared Aug 15, 2007
LANX DEFORMITY SYSTEM
K071633 · KWP
Lanx, LLC
Orthopedic · 62d
Cleared Aug 15, 2007
CRYSTALVIEW T-SERIES COMPUTED RADIOGRAPHY SYSTEM, MODELS T110 (WITH ERASER)...
K071682 · MQB
Alara, Inc.
Radiology · 57d
Cleared Aug 15, 2007
AMPLATZER VASCULAR PLUG II, MODELS AVP2-003, AVP2-018, AVP2-020, AVP2-022
K071699 · KRD
Aga Medical Corp.
Cardiovascular · 55d
Cleared Aug 15, 2007
EXACTECH OPTETRAK PROXIMAL TIBIAL SPACER
K071738 · JWH
Exactech, Inc.
Orthopedic · 50d
Cleared Aug 15, 2007
BEAUTIFIL II
K071742 · EBF
Shofu Dental Corp.
Dental · 49d
Cleared Aug 15, 2007
ENDOHUB- 1.0 ENDOSCOPIC VIDEO CAMERA SYSTEM WITH VIDEO CAPTURE
K071756 · GCJ
Pointe Conception Medical, Inc.
General & Plastic Surgery · 48d
Cleared Aug 15, 2007
MINI TIGHTROPE FT REPAIR KIT
K071978 · HTN
Arthrex, Inc.
Orthopedic · 28d
Cleared Aug 15, 2007
MODIFICATION TO SCORPIO NRG KNEE SYSTEM
K071991 · JWH
Howmedica Osteonics Corp.
Orthopedic · 26d
Cleared Aug 15, 2007
HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC)
K071992 · IYE
Varian Medical Systems
Radiology · 26d
Cleared Aug 15, 2007
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K072001 · LYZ
Tangshan Hongyun Plastic Products...
General Hospital · 23d
Cleared Aug 15, 2007
STRAUMANN P.004 CEMENTABLE ABUTMENTS, TEMPORARY COPINGS AND PROTECTIVE CAPS
K072071 · NHA
Institut Straumann AG
Dental · 16d
Cleared Aug 14, 2007
NEOGUIDE ENDOSCOPY SYSTEM
K070622 · FDF
Neoguide Systems, Inc.
Gastroenterology & Urology · 161d
Cleared Aug 14, 2007
T2 XVBR SPINAL SYSTEM
K071033 · MQP
Medtronic Sofamor Danek
Orthopedic · 124d
Cleared Aug 14, 2007
BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS)
K071710 · IMD
Johnson & Johnson Consumer Products,...
Physical Medicine · 53d
Cleared Aug 14, 2007
MASTERSCREEN PNEUMO & MASTERSCOPE
K071753 · BTY
Viasys Healthcare GmbH
Anesthesiology · 47d
Cleared Aug 14, 2007
PTFE FLIXENE GRADUATED WALL GRAFT
K071923 · DSY
Atrium Medical Corp.
Cardiovascular · 33d
Cleared Aug 14, 2007
MAGNETOM ESSENZA
K071925 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 33d
Cleared Aug 14, 2007
GRAFTLOCK SCREW, ST SCREW
K071952 · HWC
Biocomposites, Ltd.
Orthopedic · 29d
Cleared Aug 14, 2007
20.8-INCH (53CM) COLOR LCD MONITOR CDL2119A (CCL352I2)
K072065 · LLZ
Totoku Electric Co., Ltd.
Radiology · 18d