FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

5,198 results for "health"
1273–1296 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jun 06, 2018
uMR 560
K180926 · LNH
Shanghai United Imaging Healthcare...
Radiology · 58d
Cleared Jun 06, 2018
uMR 570
K180925 · LNH
Shanghai United Imaging Healthcare...
Radiology · 58d
Cleared May 25, 2018
ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)
K181082 · NDY
Siemens Healthcare Diagnostics, Inc.
Chemistry · 31d
Cleared May 24, 2018
McKesson Cardiology
K181080 · LLZ
Change Healthcare Israel , Ltd.
Radiology · 30d
Cleared May 18, 2018
The IQoolTM Warm System
K180375 · DWJ
Braincool AB
Cardiovascular · 95d
Cleared May 16, 2018
Low Dose CT Lung Cancer Screening Option
K180901 · JAK
Hitachi Healthcare Americas
Radiology · 40d
Cleared May 14, 2018
Clarius Ultrasound Scanner
K180799 · IYN
Clarius Mobile Health Corp.
Radiology · 48d
Cleared May 14, 2018
Pristina Serena
K173576 · MUE
Ge Healthcare
Radiology · 175d
Cleared May 11, 2018
Spectrum IQ Infusion System, Dose IQ Safety Software
K173084 · FRN
Baxter Healthcare Corporation
General Hospital · 224d
Cleared May 11, 2018
HealthBeacon HB2 Sharps Bin
K172719 · MMK
Healthbeacon, Ltd.
General Hospital · 245d
Cleared May 04, 2018
Invenia ABUS Viewer
K180641 · LLZ
Ge Healthcare
Radiology · 53d
Cleared May 01, 2018
PeraServer and PeraTrend
K172959 · MWI
Perahealth, Inc.
Cardiovascular · 217d
Not Cleared Apr 26, 2018
Cala ONE
DEN170028 · QBC
Cala Health, Inc.
Neurology · 344d
Cleared Apr 25, 2018
syngo.plaza
K180563 · LLZ
Siemens Healthcare GmbH
Radiology · 51d
Cleared Apr 17, 2018
NM/CT 850, NM/CT 860
K173816 · KPS
Ge Healthcare
Radiology · 123d
Cleared Apr 13, 2018
SmartGrid
K180667 · MQB
Carestream Health, Inc.
Radiology · 30d
Cleared Apr 13, 2018
uMI 780 PET/CT System
K172143 · KPS
Shanghai United Imaging Healthcare...
Radiology · 270d
Cleared Apr 12, 2018
48CH Head Coil
K180666 · MOS
Ge Healthcare Coils (Usa Instruments,...
Radiology · 29d
Cleared Apr 12, 2018
Atellica IM Folate Assay
K172201 · CGN
Siemens Healthcare Diagnostics, Inc.
Chemistry · 265d
Cleared Apr 05, 2018
DR 800 with MUSICA Dynamic
K180589 · JAA
Agfa Healthcare N.V.
Radiology · 30d
Cleared Apr 05, 2018
uWS-MI
K172998 · LLZ
Shanghai United Imaging Healthcare...
Radiology · 190d
Cleared Mar 29, 2018
Voluson P6 and Voluson P8
K180535 · IYN
Ge Healthcare
Radiology · 29d
Cleared Mar 29, 2018
Atellica IM Total hCG (ThCG)
K172322 · JHI
Siemens Healthcare Diagnostics, Inc.
Chemistry · 240d
Cleared Mar 23, 2018
SRT-100+
K173425 · JAD
Sensus Healthcare, Inc.
Radiology · 141d