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
66145–66168 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 21, 2005
MODIFICATION TO ARM BLOOD PRESSURE MONITOR, MODELS KP-6821, KP-6822
K043531 · DXN
K-Jump Health Co., Ltd.
Cardiovascular · 121d
Cleared Apr 21, 2005
ACTICOAT MOISTURE CONTROL DRESSING
K050030 · FRO
Smith & Nephew, Inc.
General & Plastic Surgery · 104d
Cleared Apr 21, 2005
CAMCERAM TCP
K050357 · MQV
Cam Implants B.V.
Orthopedic · 66d
Cleared Apr 21, 2005
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS
K050404 · HET
Intuitive Surgical, Inc.
Obstetrics & Gynecology · 63d
Cleared Apr 21, 2005
EUROCHAIR
K050560 · IOR
Meyra, Inc.
Physical Medicine · 49d
Cleared Apr 21, 2005
MICROALBUMIN TIA REAGENT
K050576 · DDZ
Good Biotech Corp.
Chemistry · 45d
Cleared Apr 21, 2005
VERTEVIEW ANTERIOR CERVICAL PLATE SYSTEM
K050588 · KWQ
Innovative Spinal Design, LLC
Orthopedic · 44d
Cleared Apr 21, 2005
STRYKER NAVIGATION SYSTEM - CT-BASED HIP MODULE, MODEL 6007-621-000
K050615 · HAW
Stryker Instruments
Neurology · 43d
Cleared Apr 21, 2005
21.3-INCH (54CM) COLOR LCD MONITOR, MODELS CDL2113A, CCL250I & DV2MC-HB
K050616 · LLZ
Totoku Electric Co., Ltd.
Radiology · 42d
Cleared Apr 21, 2005
TRIAL CABLE RETENTION CLIP
K050633 · GZB
Advanced Neuromodulation Systems
Neurology · 41d
Cleared Apr 21, 2005
SYNTHES 3.0MM HEADLESS COMPRESSION SCREWS
K050636 · HWC
Synthes (Usa)
Orthopedic · 41d
Cleared Apr 21, 2005
R. POON MEDICAL PRODUCTS WHEELCHAIRS
K050691 · IOR
R. Poon Medical Products Co., Ltd.
Physical Medicine · 35d
Cleared Apr 21, 2005
QBRAIN
K050703 · LLZ
Medis Medical Imaging Systems BV
Radiology · 34d
Cleared Apr 21, 2005
ISCIENCE SURGICAL VISCOINJECTOR
K050716 · MRH
Iscience Surgical Corporation
Ophthalmic · 31d
Cleared Apr 21, 2005
KAVO ERGOCOM/ERGOCAM
K050744 · LLZ
Kavo America Corporation
Radiology · 30d
Cleared Apr 21, 2005
IMPAX ORTHOPAEDIC WORKSTATION, MODEL IMPAX ES 5.X
K050751 · LLZ
Agfa Corp.
Radiology · 29d
Cleared Apr 21, 2005
NAVIGUS REUSABLE PASSIVE PROBE, MODEL SP-2000
K050772 · HAW
Image-Guided Neurologics, Inc.
Neurology · 27d
Cleared Apr 21, 2005
LANDLEX, MODEL S300X
K050792 · INI
Cycling and Health Tech. Industry R&D...
Physical Medicine · 24d
Cleared Apr 21, 2005
AGFA CR50.0
K050810 · MQB
Agfa Corp.
Radiology · 21d
Cleared Apr 20, 2005
SMITH & NEPHEW INTELIJET FLUID MANAGEMENT SYSTEMS
K050580 · HRX
Smith & Nephew Endoscopy, Inc.
Orthopedic · 44d
Cleared Apr 20, 2005
ALL-IN-ONE
K050647 · KLE
Bisco, Inc.
Dental · 37d
Cleared Apr 20, 2005
MG II TOTAL KNEE SYSTEM STEMMED TIBIAL BASEPLATE COMPONENTS
K050723 · JWH
Zimmer, Inc.
Orthopedic · 30d
Cleared Apr 20, 2005
PROTEGE GPS SELF-EXPANDING NITINOL STENT
K050725 · FGE
Ev3 Corporation
Gastroenterology & Urology · 30d
Cleared Apr 20, 2005
URISCAN OPTIMA II URINE ANALYZER
K050801 · JIL
Yd Diagnostics
Chemistry · 21d