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
27337–27360 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 30, 2017
Fortis and Hana Anterior Cervical Plate System
K173099 · KWQ
Huvexel Co. , Ltd.
Orthopedic · 62d
Cleared Nov 30, 2017
ReliefBand 1.5
K173233 · GZJ
Reliefband Technologies
Neurology · 56d
Cleared Nov 30, 2017
Graft Delivery, DePuy Synthes
K173385 · FMF
Micromedics, Inc. (D/B/A Nordson...
General Hospital · 31d
Cleared Nov 30, 2017
Endophys Pressure Sensing Sheath Kit- 8F
K173399 · DYB
Endophys Holdings, LLC
Cardiovascular · 30d
Cleared Nov 30, 2017
Solanas® Posterior Stabilization System
K173522 · NKB
Alphatec Spine, Inc.
Orthopedic · 16d
Cleared Nov 29, 2017
Lucent®
K170235 · MAX
Spinal Elements, Inc.
Orthopedic · 308d
Cleared Nov 29, 2017
Quingo Classic Power Scooter S1301, Quingo Flyte Power Scooter S551, Quingo...
K170634 · INI
Advanced Vehicle Concepts , Ltd.
Physical Medicine · 272d
Cleared Nov 29, 2017
M-Vizion Femoral Revision System
K170690 · LZO
Medacta International S.A.
Orthopedic · 267d
Cleared Nov 29, 2017
Collision Check
K171350 · IYE
Radformation, Inc.
Radiology · 204d
Cleared Nov 29, 2017
NobelDesign, DTX Studio Design
K171466 · NHA
Nobel Biocare AB
Dental · 195d
Cleared Nov 29, 2017
s-Clean TiN Coating Abutments
K171694 · NHA
Dentis Co., Ltd.
Dental · 175d
Cleared Nov 29, 2017
HIVOX OTC Electrical Stimulator
K171803 · NUH
Hivox Biotek, Inc.
Neurology · 163d
Cleared Nov 29, 2017
Brisbane ALIF Device, Gladstone ALIF Device
K172019 · OVD
Signature Orthopaedics Pty, Ltd.
Orthopedic · 147d
Cleared Nov 29, 2017
Arlington PLIF/TLIF Cage
K172020 · MAX
Signature Orthopaedics Pty, Ltd.
Orthopedic · 147d
Cleared Nov 29, 2017
One Mum Pumpset
K172067 · HGX
Ardo Medical AG
Obstetrics & Gynecology · 145d
Cleared Nov 29, 2017
ICONN Square 2.5MM Suture Anchor
K172491 · MBI
Iconn Orthopedics, LLC
Orthopedic · 104d
Cleared Nov 29, 2017
DESCRIBE PFD Patch
K172689 · PKO
Merz North America, Inc.
General & Plastic Surgery · 84d
Cleared Nov 29, 2017
Epic Pro 940
K172771 · GEX
Biolase, Inc.
General & Plastic Surgery · 76d
Cleared Nov 29, 2017
Suction Irrigation Set
K172794 · GCJ
Wickimed (Huizhou) Medical Equipment...
General & Plastic Surgery · 75d
Cleared Nov 28, 2017
DIAZIR
K161652 · EIH
Zxtgy (Beijing) Technology Co., Ltd.
Dental · 531d
Cleared Nov 28, 2017
Meridian PM
K170053 · LRK
The Center For Craniofacial & Dental...
Dental · 327d
Cleared Nov 28, 2017
PIT’Stop® implant
K170688 · HWC
In2bones Sas
Orthopedic · 266d
Cleared Nov 28, 2017
Portable Nebulizer
K170916 · CAF
Microbase Technology Corporation
Anesthesiology · 244d
Cleared Nov 28, 2017
TOKUYAMA UNIVERSAL BOND
K171226 · KLE
Tokuyama Dental Corporation
Dental · 216d