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"
1081–1104 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Oct 19, 2019
Altapore Shape
K191513 · MQV
Baxter Healthcare Corporation
Orthopedic · 134d
Cleared Oct 18, 2019
BIAFINE Topical Cream
K190342 · FRO
Bausch Health Americas Incorporated
General & Plastic Surgery · 246d
Cleared Oct 17, 2019
Merge PACS
K192455 · LLZ
Merge Healthcare Incorporated
Radiology · 38d
Cleared Oct 11, 2019
F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask...
K190713 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 206d
Cleared Oct 11, 2019
Protego Antimicrobial Wound Dressing
K183681 · FRO
Global Health Solutions (Dba Turn...
General & Plastic Surgery · 287d
Cleared Oct 10, 2019
VERA
K192474 · LXJ
Reflexion Health, Inc.
Physical Medicine · 30d
Cleared Oct 03, 2019
Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe
K190208 · FFX
Diversatek Healthcare
Gastroenterology & Urology · 241d
Cleared Oct 01, 2019
Signa Voyager, Signa Voyager Quantum
K192426 · LNH
Ge Healthcare (Tianjin) Company Limited
Radiology · 26d
Cleared Sep 25, 2019
NuStat
K183190 · POD
Beeken Biomedical, LLC
General & Plastic Surgery · 310d
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