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

Filters: Cleared only ×
175,820 results
29497–29520 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 04, 2017
System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight
K170731 · MUH
VATECH Co., Ltd.
Radiology · 25d
Cleared Apr 04, 2017
MX50N(MX50YQS)
K170781 · PGY
Wide Corporation
Radiology · 20d
Cleared Apr 03, 2017
ESTELITE BULK FILL Flow
K161353 · EBF
Tokuyama Dental Corporation
Dental · 322d
Cleared Apr 03, 2017
TITAN 3-D™ Wedge System
K162241 · PLF
Paragon 28
Orthopedic · 236d
Cleared Apr 03, 2017
ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire...
K163426 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 118d
Cleared Apr 03, 2017
AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5)
K170075 · PQN
Airxpanders, Inc.
General & Plastic Surgery · 84d
Cleared Mar 31, 2017
MultiPulse HoPLUS
K161257 · GEX
Asclepion Laser Technologies GmbH
General & Plastic Surgery · 331d
Cleared Mar 31, 2017
Bluetooth blood pressure monitor
K161530 · DXN
Shenzhen Kingyield Technology Co., Ltd.
Cardiovascular · 302d
Cleared Mar 31, 2017
AMIStem-H Proximal Coating
K161635 · LZO
Medacta International S.A.
Orthopedic · 290d
Cleared Mar 31, 2017
Caphosol Artifical Saliva Tablets
K162167 · LFD
Eusa Pharma (Uk) Limited
Dental · 240d
Cleared Mar 31, 2017
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY]...
K162186 · LZC
Brightway Holdings Sdn. Bhd.
General Hospital · 239d
Cleared Mar 31, 2017
StealthStation S8 System Platforms and StealthStation Cranial Software
K162309 · HAW
Medtronic Navigation, Inc.
Neurology · 226d
Cleared Mar 31, 2017
AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low...
K162413 · MLR
STERIS Corporation
General Hospital · 214d
Cleared Mar 31, 2017
Multichem IA Plus
K162530 · JJY
Techno-Path Manufacturing
Chemistry · 203d
Cleared Mar 31, 2017
Move Forward 3D Motion Simulation Service
K162559 · LLZ
Biomet, Inc.
Radiology · 198d
Cleared Mar 31, 2017
THERMOPLASTIC POLYETHYLENE EXAMINATION (TPE) GLOVE
K162626 · LZA
Top Quality Glove Sdn. Bhd
General Hospital · 192d
Cleared Mar 31, 2017
EnsoSleep
K162627 · OLZ
Ensodata, Inc.
Neurology · 192d
Cleared Mar 31, 2017
AC3 Series IABP System
K162820 · DSP
Arrow International, Inc.
Cardiovascular · 175d
Cleared Mar 31, 2017
MEP Monitor
K162873 · GWF
Tonica Elektronik A/S
Neurology · 169d
Cleared Mar 31, 2017
GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System
K163096 · NKB
Gpc Medical Limited
Orthopedic · 147d
Cleared Mar 31, 2017
Multibase Abutments EV and ATLANTIS Suprastructures
K163350 · NHA
Dentsply Sirona
Dental · 121d
Cleared Mar 31, 2017
SureSigns VS3
K163649 · DSJ
Philips Medical Systems
Cardiovascular · 98d
Cleared Mar 31, 2017
ICONIX TT All Suture Anchor
K170098 · MBI
Stryker
Orthopedic · 79d
Cleared Mar 31, 2017
LOSPA IS TLIF & DLIF Cages
K170243 · MAX
Corentec Co., Ltd.
Orthopedic · 64d