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
30025–30048 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 31, 2017
Philips CombiDiagnost R90
K163210 · JAA
Philips Medical Systems Dmc GmbH
Radiology · 77d
Cleared Jan 31, 2017
CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion...
K163542 · DSP
Datascope Corp.
Cardiovascular · 46d
Cleared Jan 30, 2017
OBS Electrosurgical Generator (Model: OBS-350A)
K162034 · GEI
Baisheng Medical Co., Ltd.
General & Plastic Surgery · 192d
Cleared Jan 30, 2017
LED Phototherapy Device
K162098 · OLP
Li-Tek Electronic Technology Corporation
General & Plastic Surgery · 185d
Cleared Jan 30, 2017
ET Hybrid Abutment
K162390 · NHA
Hiossen, Inc.
Dental · 157d
Cleared Jan 30, 2017
Elite Expandable Interbody Fusion Device
K162879 · MAX
Spineology, Inc.
Orthopedic · 108d
Cleared Jan 30, 2017
Radifocus Glidewire Advantage Track
K163004 · DQX
Ashitaka Factory of Terumo Coporation
Cardiovascular · 94d
Cleared Jan 30, 2017
Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle
K163058 · ODG
Boston Scientific
Gastroenterology & Urology · 90d
Cleared Jan 27, 2017
Universa Firm Ureteral Stents and Stent Sets
K161236 · FAD
Cook Incorporated
Gastroenterology & Urology · 270d
Cleared Jan 27, 2017
Advanced Gynecological Applicator
K161688 · JAQ
Nucletron B.V.
Radiology · 221d
Cleared Jan 27, 2017
Philips IntelliVue GuardianSoftware
K161767 · DXJ
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 214d
Cleared Jan 27, 2017
FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm
K161967 · KRA
Callisyn Biomedical, Inc.
Cardiovascular · 193d
Cleared Jan 27, 2017
Ecomed Disposable Angiographic Syringes
K162088 · DXT
Ecomed Solutions, LLC
Cardiovascular · 183d
Cleared Jan 27, 2017
EBM iDO Viewer 1.2.1
K162285 · LLZ
Ebm Technologies Incorporated
Radiology · 165d
Cleared Jan 27, 2017
L300 Go System
K162407 · GZI
Bioness, Inc.
Neurology · 151d
Cleared Jan 27, 2017
Vado Bi-Directional Steerable Sheath
K162427 · DYB
Kalila Medical, Inc.
Cardiovascular · 150d
Cleared Jan 27, 2017
VERIFY STEAM Integrating Indicator - Short
K162631 · JOJ
STERIS Corporation
General Hospital · 128d
Cleared Jan 27, 2017
ASAHI PTCA Guide Wire ASAHI SUOH 03
K162842 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 108d
Cleared Jan 27, 2017
CSX-30 Flat Panel Detector
K162909 · MQB
Canon Inc. -Medical Equipment Group
Radiology · 102d
Cleared Jan 27, 2017
chromID Strepto B agar
K163042 · PQZ
bioMerieux, Inc.
Microbiology · 88d
Cleared Jan 27, 2017
MAGNETOM Sempra with syngo MR E11S
K163211 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 72d
Cleared Jan 27, 2017
RP Lite 760R
K163280 · IRP
Mego Afek AC , Ltd.
Physical Medicine · 67d
Cleared Jan 27, 2017
MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 Software
K163312 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 65d
Cleared Jan 27, 2017
nordicBrainEx
K163324 · LLZ
Nordicneurolab AS
Radiology · 63d