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

5,276 results for "health"
1129–1152 of 5,276
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Sep 20, 2019
Merge Cardio
K192276 · LLZ
Merge Healthcare Incorporated
Radiology · 29d
Cleared Sep 16, 2019
Full Automatic (NIBP) Blood Pressure Monitor
K190507 · DXN
Health & Life Co., Ltd.
Cardiovascular · 199d
Cleared Sep 13, 2019
RFID Localization System
K190932 · NEU
Health Beacons, Inc.
General & Plastic Surgery · 156d
Cleared Sep 13, 2019
SCENARIA View
K190841 · JAK
Hitachi Healthcare Americas
Radiology · 165d
Cleared Sep 12, 2019
uDR 592h, uDR 596i
K192293 · KPR
Shanghai United Imaging Healthcare...
Radiology · 20d
Cleared Sep 11, 2019
3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure...
K191355 · FXX
3M Healthcare
General Hospital · 113d
Cleared Sep 11, 2019
PeraMobile and PeraWatch
K183370 · MWI
Perahealth, Inc.
Cardiovascular · 281d
Cleared Sep 07, 2019
Focus TENS Therapy, Model PM710-M/-L
K183215 · NUH
Omron Healthcare, Inc.
Neurology · 292d
Cleared Sep 06, 2019
Lumify Diagnostic Ultrasound System
K192226 · IYN
Philips Health Care
Radiology · 21d
Cleared Sep 06, 2019
SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes
K183574 · DPW
Huntleigh Healthcare , Ltd.
Cardiovascular · 259d
Cleared Sep 04, 2019
Myo Plus
K191179 · GXY
Otto Bock Healthcare Products GmbH
Neurology · 125d
Cleared Aug 29, 2019
Voluson E6, Voluson E8, Voluson E10
K192159 · IYN
Ge Healthcare
Radiology · 20d
Cleared Aug 29, 2019
Clarius Ultrasound Scanner
K192107 · IYN
Clarius Mobile Health Corp.
Radiology · 24d
Cleared Aug 29, 2019
BD MAX Check-Points CPO
K190613 · POC
Check-Points Health B.V.
Microbiology · 171d
Cleared Aug 28, 2019
ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG
K191533 · CDZ
Siemens Healthcare Diagnostics, Inc.
Chemistry · 79d
Cleared Aug 23, 2019
Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheter
K190127 · NLH
Innovative Health, LLC
Cardiovascular · 207d
Cleared Aug 15, 2019
HCT Empty EVA Container Pack
K190328 · KPE
Health Care Technologies
General Hospital · 183d
Cleared Aug 15, 2019
OneDraw A1C Test System
K183230 · LCP
Drawbridge Health, Inc.
Chemistry · 268d
Cleared Aug 09, 2019
ARIETTA 750
K191233 · IYN
Hitachi Healthcare Americas
Radiology · 93d
Cleared Aug 08, 2019
binx health io CT/NG Assay
K191352 · QEP
Binx Health, Inc.
Microbiology · 80d
Cleared Jul 30, 2019
Atellica CH Amylase_2 (AMY_2)
K191454 · JFJ
Siemens Healthcare Diagnostics, Inc.
Chemistry · 60d
Cleared Jul 29, 2019
Access CT
K191136 · JAK
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 91d
Cleared Jul 29, 2019
Non-invasive blood pressure measurement systems
K190886 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 116d
Cleared Jul 29, 2019
Sample Imaging for Senographe Pristina
K190809 · MUE
Ge Healthcare
Radiology · 122d