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
47953–47976 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 18, 2011
AXSOS (TM) LOCKING PLATE SYSTEM
K110476 · HRS
Stryker Corp.
Orthopedic · 28d
Cleared Mar 18, 2011
PROSOUND C3 / C3 CV ULTRASOUND SYSTEMS
K110482 · IYN
Teratech Corp.
Radiology · 28d
Cleared Mar 18, 2011
ASAHI TREASURE FLOPPY PERIPHERAL GUIDE WIRE
K110553 · DQX
Asahi Intecc USA, Inc.
Cardiovascular · 18d
Cleared Mar 18, 2011
SENTINELLA 102
K110601 · IYX
General Equipment For Medical...
Radiology · 16d
Cleared Mar 17, 2011
HEMOSIL PROTEIN S ACTIVITY ASSAY
K102164 · GGP
Instrumentation Laboratory CO
Hematology · 227d
Cleared Mar 17, 2011
WINSTIM
K102190 · IMG
Johari Digital Healthcare , Ltd.
Physical Medicine · 226d
Cleared Mar 17, 2011
PATIENT EXAMINATION GLOVES
K102846 · LZA
Thai Hua Holding Co., Ltd.
General Hospital · 169d
Cleared Mar 17, 2011
REVERE SACRAL PLATES
K103072 · NKB
Globus Medical, Inc.
Orthopedic · 150d
Cleared Mar 17, 2011
NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM
K103416 · OWB
Infimed, Inc.
Radiology · 115d
Cleared Mar 17, 2011
EVEREST SPINAL SYSTEM
K103440 · MNI
K2m, Inc.
Orthopedic · 114d
Cleared Mar 17, 2011
AYCAN WORKSTATION OSIRIX PRO
K103546 · LLZ
Aycan Digitalsysteme GmbH
Radiology · 105d
Cleared Mar 17, 2011
PRIMUS AESTHETIC PLATFORM
K103664 · ONG
Palomar Medical Technologies, Inc.
General & Plastic Surgery · 91d
Cleared Mar 17, 2011
PLANMECA PROMAX 3D MID
K103689 · MUH
Planmeca Oy
Radiology · 90d
Cleared Mar 17, 2011
ACCELL EVO3 (FORMERLY ACCELL A2I)
K103742 · MBP
Integra Life Sciences
Orthopedic · 84d
Cleared Mar 17, 2011
CONCORDE CURVE SYSTEM
K103743 · MAX
Johnson & Johnson
Orthopedic · 84d
Cleared Mar 17, 2011
PEZO INTERBODY CAGES SYSTEM
K103814 · MAX
Ulrich GmbH & Co. KG
Orthopedic · 78d
Cleared Mar 17, 2011
MASIMO RADICAL Y PULSE CO-OXIMETER
K110028 · DQA
Masimo Corporation
Anesthesiology · 71d
Cleared Mar 17, 2011
ENCOMPASS HF100- EAGLE PANORAMIC/CEPHALOMETRIC X-RAY
K110371 · MUH
Panoramic Corp.
Radiology · 37d
Cleared Mar 17, 2011
FLEXFUSION (TM) FIXATION IMPLANT
K110445 · HWC
Nextremity Solutions, LLC
Orthopedic · 29d
Cleared Mar 16, 2011
AAXTER A3 POSTERIOR SPINAL SYSTEM
K101374 · MNH
Aaxter Co., Ltd.
Orthopedic · 303d
Cleared Mar 16, 2011
IVD-GE02
K101947 · CGA
Sphere Medical , Ltd.
Chemistry · 247d
Cleared Mar 16, 2011
LENSAR LASER SYSTEM FOR ANTERIOR CAPSULOTOMY
K102727 · OOE
Lensar, Inc.
Ophthalmic · 175d
Cleared Mar 16, 2011
IPLAN RT
K103246 · MUJ
Brainlab AG
Radiology · 133d
Cleared Mar 16, 2011
NHANES WHOLE BODY DXA REFERENCE DATABASE
K103265 · KGI
Hologic, Inc.
Radiology · 132d