FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
22657–22680 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 03, 2019
Arm-type Electronic Blood Pressure Monitor
K183058 · DXN
Shenzhen Bsx Technology Electronics...
Cardiovascular · 243d
Cleared Jul 03, 2019
Bluephase PowerCure
K190272 · EBZ
Ivoclar Vivadent, AG
Dental · 145d
Cleared Jul 03, 2019
Koios DS for Breast
K190442 · POK
Koios Medical, Inc.
Radiology · 128d
Cleared CT Jul 03, 2019
Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia...
K190589 · PFO
Cochlear Americas
Ear, Nose, Throat · 118d
Cleared Jul 03, 2019
MD-Temp Plus
K190724 · EBG
Meta Biomed Co., Ltd.
Dental · 105d
Cleared Jul 03, 2019
OsteoFab Suture Anchors
K190915 · MBI
Oxford Performance Materials, Inc.
Orthopedic · 85d
Cleared Jul 03, 2019
ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal...
K190959 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 82d
Cleared Jul 03, 2019
Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2...
K191018 · NLF
Surgical Instrument Service and...
Anesthesiology · 77d
Cleared Jul 03, 2019
NuVasive® Camber Laminoplasty System
K191169 · NQW
Nu Vasive, Incorporated
Orthopedic · 63d
Cleared Jul 03, 2019
Infinity Fixation System
K191204 · MBI
Conmed Corporation
Orthopedic · 58d
Cleared Jul 03, 2019
CMDR 2CW (Multiple models)
K191451 · IZL
Minxray, Inc.
Radiology · 33d
Cleared Jul 03, 2019
syngo.CT Dual Energy
K191468 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 30d
Cleared Jul 03, 2019
Biopsy Positioner
K191495 · IZH
Fujifilm Corporation
Radiology · 28d
Cleared Jul 02, 2019
Uro-N Cystoscope
K182876 · FAJ
Uroviu Corporation
Gastroenterology & Urology · 263d
Cleared Jul 02, 2019
Certain BellaTek Express and BellaTek Flex Abutments
K183138 · NHA
Biomet 3i
Dental · 231d
Cleared Jul 02, 2019
Site Seal SV
K190351 · DXC
Ensite Vascular
Cardiovascular · 138d
Cleared Jul 02, 2019
Wrap accessory electrodes
K190617 · GXY
Hi-Dow International, Inc.
Neurology · 113d
Cleared Jul 02, 2019
Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral...
K190634 · MCW
Cardiovascular Systems, Inc.
Cardiovascular · 112d
Cleared Jul 02, 2019
Twilite Appliance
K190687 · LRK
Stephen J Harkins, Dds, PC
Dental · 106d
Cleared Jul 02, 2019
iLab Polaris Multi-Modality Guidance System
K191008 · DQK
Boston Scientific Corporation
Cardiovascular · 77d
Cleared Jul 02, 2019
5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500
K191137 · PGY
Jvckenwood Corporation
Radiology · 64d
Cleared Jul 02, 2019
PWD Platform Wound Dressing 3” x 5” Oblong
K191460 · OMP
Applied Tissue Technologies, LLC
General & Plastic Surgery · 29d
Cleared Jul 01, 2019
Hudson RCI Voldyne Volumetric Exerciser
K182847 · BWF
Teleflexmedical, Inc.
Anesthesiology · 265d
Cleared Jul 01, 2019
ASAHI Silverway
K183062 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 238d