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
45817–45840 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 01, 2011
HYDROCOIL(R) EMBOLIC SYSTEM (HES)
K112181 · HCG
MicroVention, Inc.
Neurology · 126d
Cleared Dec 01, 2011
LATERAL BUTTON
K112296 · MBI
T.A.G. Medical Products Corporation,...
Orthopedic · 114d
Cleared Dec 01, 2011
RANDOX LIQUID IMMUNOASSAY PREMIUM CONTROLS, LEVEL 1, LEVEL2, LEVEL 3 AND TRI...
K112337 · JJY
Randox Laboratories, Ltd.
Chemistry · 108d
Cleared Dec 01, 2011
MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIES
K112782 · NRB
Misonix, Inc.
General & Plastic Surgery · 66d
Cleared Dec 01, 2011
JENSEN ZIRCONIA
K112806 · EIH
Jensen Industries, Inc.
Dental · 65d
Cleared Dec 01, 2011
AMSCO V-PRO
K112813 · MLR
Steris Corp
General Hospital · 65d
Cleared Dec 01, 2011
ASAHI CHIKAI 10 NEUROVASCULAR GUIDE WIRE
K112979 · MOF
Asahi Intecc Co., Ltd.
Neurology · 56d
Cleared Dec 01, 2011
SNAP WOUND CARE SYSTEM
K113032 · OKO
Spiracur, Inc.
General & Plastic Surgery · 50d
Cleared Dec 01, 2011
NARVAL CC
K113201 · LQZ
Resmed Sas
Dental · 31d
Cleared Dec 01, 2011
RENAISSANCE SYSTEM
K113228 · HAW
Mazor Robotics , Ltd.
Radiology · 30d
Cleared Nov 30, 2011
DESARA MINI
K103418 · PAH
Caldera Medical, Inc.
Gastroenterology & Urology · 373d
Cleared Nov 30, 2011
VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOAZOLE
K110106 · LON
bioMerieux, Inc.
Microbiology · 321d
Cleared Nov 30, 2011
DIGNITY MINI PORT- ATTACHABLE
K110424 · LJT
Medcomp ( Medical Components)
General Hospital · 289d
Cleared Nov 30, 2011
FLAATZ 760
K111655 · KPR
Drtech Corp.
Radiology · 170d
Cleared Nov 30, 2011
NON-CONTACT TEAR FILM THERMOGRAGH
K111771 · HKI
United Integrated Services Co., Ltd.
Ophthalmic · 160d
Cleared Nov 30, 2011
5MP MONOCHROME LCD MONITOR, RADIFORCE GX530
K112354 · LLZ
Eizo Nanao Corporation
Radiology · 106d
Cleared Nov 30, 2011
ALAMO C
K112361 · ODP
Alliance Partners, LLC
Orthopedic · 105d
Cleared Nov 30, 2011
CENTRICITY CARDIO IMAGING
K112570 · LLZ
Ge Healthcare Integrated IT Solutions
Radiology · 85d
Cleared Nov 30, 2011
CHARGER PTA BALLON DILATATION CATHETER
K112697 · LIT
Boston Scientific
Cardiovascular · 75d
Cleared Nov 29, 2011
SURECORE BIOPSY DEVICE
K102756 · KNW
Chest Innovations, Inc.
Gastroenterology & Urology · 432d
Cleared Nov 29, 2011
FOUNDATION
K111087 · LYC
Olympus Terumo Biomaterials Corporation
Dental · 224d
Cleared Nov 29, 2011
RHAUSLER PLAGE ANTERIOR CERVICAL FUSION SYSTEM
K111272 · OVE
Rhausler, Inc.
Orthopedic · 209d
Cleared Nov 29, 2011
BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM
K111908 · HWC
Biomet Microfixation, Inc.
Orthopedic · 147d
Cleared Nov 28, 2011
RAPTOR FACET FIXATION SYSTEM
K110170 · MRW
Alphatec Spine, Inc.
Orthopedic · 312d