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
41089–41112 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 06, 2013
AQUILION PRIME, V5.00
K130645 · JAK
Toshibamedical Systems Corporation
Radiology · 87d
Cleared Jun 06, 2013
ACUSON S2000 AND S3000 DIAGNOSTIC ULTRASOUND SYSTEMS
K130739 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 80d
Cleared Jun 06, 2013
XRES BLOOD COLLECTION RESERVOIR XRES 120MICROMETER BLOOD COLLECTION RESERVOIR
K131103 · DTN
Sorin Group Italia S.R.L.
Cardiovascular · 48d
Cleared Jun 06, 2013
VECTOR PTA BALLOON DILATATION CATHETER
K131329 · LIT
R4 Vascular, Inc.
Cardiovascular · 29d
Cleared Jun 06, 2013
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
K131346 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 28d
Cleared Jun 05, 2013
NOBELPROCERA PEEK ABUTMENTS
K120954 · NHA
Nobel Biocare AB
Dental · 432d
Cleared Jun 05, 2013
PHOTON PHOTON PLUS
K122020 · GEX
Zolar Technology & Mfg Co., Inc.
General & Plastic Surgery · 330d
Cleared Jun 05, 2013
TRC-50DX RETINAL CAMERA
K123101 · HKI
Topcon Medical Systems, Inc.
Ophthalmic · 244d
Cleared Jun 05, 2013
ILLUMIGENE MYCOPLASAMA DNA AMPLIFICATION ASSAY, AND ILLUMIGENE MYCOPLASMA...
K123423 · OZX
Meridian Bioscience, Inc.
Microbiology · 211d
Cleared Jun 05, 2013
ABBOTT CARBAMAZEPINE ASSAY
K123518 · KLT
Microgenics Corporation
Toxicology · 203d
Cleared Jun 05, 2013
NEUROEPG SYSTEM
K123843 · GWF
Strohl Medical Technologies
Neurology · 174d
Cleared Jun 05, 2013
F&P SIMPLUS FULL FACE MASK
K130328 · BZD
Fisher & Paykel Healthcare Limited
Anesthesiology · 114d
Cleared Jun 05, 2013
HEARTSTRING III PROXIMAL SEAL SYSTEM
K130382 · DXC
Boston Scientific Corporation
Cardiovascular · 111d
Cleared Jun 05, 2013
PIONEER ASPECT ANTERIOR CERVICAL PLATE SYSTEM
K130427 · KWQ
Pioneer Surgical Technology, Inc.
Orthopedic · 105d
Cleared Jun 05, 2013
INSPIRACHAMBER ANTI-STATIC VALVED HOLDING CHAMBER
K130598 · NVP
Inspirx, Inc.
Anesthesiology · 90d
Cleared Jun 05, 2013
WART FREEZE
K130599 · GEH
Koninklijke Utermohlen NV
General & Plastic Surgery · 90d
Cleared Jun 05, 2013
TEMPUS PRO PATIENT MONITOR
K130773 · MWI
Remote Diagnostic Technologies , Ltd.
Cardiovascular · 77d
Cleared Jun 05, 2013
CD HORIZON SPINAL SYSTEM
K131321 · OSH
Medtronic Sofamor Danek USA
Orthopedic · 28d
Cleared Jun 04, 2013
ULTRACHECK CURVE BLOOD PRESSURE CUFFS
K122365 · OED
Statcorp Medical
Cardiovascular · 302d
Cleared Jun 04, 2013
LYOPLANT ONLAY
K122791 · GXQ
Aesculap, Inc.
Neurology · 265d
Cleared Jun 04, 2013
VIDAS LYME IGM
K122979 · LSR
Biomerieux S.A.
Microbiology · 251d
Cleared Jun 04, 2013
INFILL OBLIQUE TLIF DEVICE
K124012 · MAX
Pinnacle Spine Group, LLC
Orthopedic · 159d
Cleared Jun 04, 2013
MODIFICATION TO INTEL-GE CARE IINOVATIONS GUIDE
K130290 · DRG
Intel-Ge Care Innovations, LLC
Cardiovascular · 118d
Cleared Jun 04, 2013
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
K130640 · KWQ
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 85d