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"
961–984 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jul 31, 2020
Kendall NPWT Incision Management Dressing Kit
K191101 · OMP
Cardinalhealth
General & Plastic Surgery · 463d
Cleared Jul 30, 2020
KY Grosz Jelly
K201186 · NUC
Rb Health (Us), LLC
Obstetrics & Gynecology · 90d
Cleared Jul 30, 2020
Reprocessed NRG Transseptal Needle
K200060 · QLZ
Innovative Health, LLC
Cardiovascular · 199d
Cleared Jul 29, 2020
Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN...
K200824 · FYA
Cardinal Health200, LLC
General Hospital · 121d
Cleared Jul 24, 2020
Tempus LS - Manual
K200849 · LDD
Remote Diagnostic Technologies, Ltd....
Cardiovascular · 115d
Cleared Jul 22, 2020
Caption Interpretation Automated Ejection Fraction Software
K200621 · QIH
Caption Health
Radiology · 135d
Cleared Jul 22, 2020
Reprocessed BRK Transseptal Needle
K192998 · NMK
Innovative Health, LLC
Cardiovascular · 268d
Cleared Jul 20, 2020
Intravascular Extension Sets and Accessories
K192366 · FPA
Baxter Healthcare Corporation
General Hospital · 325d
Cleared Jul 17, 2020
SCENARIA View
K200498 · JAK
Hitachi Healthcare Americas
Radiology · 140d
Cleared Jul 16, 2020
HealthMammo
K200905 · QFM
Zebra Medical Vision, Ltd.
Radiology · 101d
Cleared Jul 15, 2020
iHealth Infrared No-Touch Forehead Thermometer
K200531 · FLL
Andon Health Co, Ltd.
General Hospital · 135d
Cleared Jul 13, 2020
Allograft MIS Delivery System
K201338 · FMF
Lifenet Health
General & Plastic Surgery · 54d
Cleared Jul 10, 2020
DigitalDiagnost C50
K201725 · KPR
Philips Healthcare (Suzhou) Co., Lit.
Radiology · 17d
Cleared Jul 09, 2020
DuraDiagnost
K201640 · KPR
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 23d
Cleared Jul 08, 2020
Digital Thermometer
K200599 · FLL
Joytech Healthcare Co. , Ltd.
General Hospital · 121d
Cleared Jul 06, 2020
uMR570
K201540 · LNH
Shanghai United Imaging Healthcare...
Radiology · 27d
Cleared Jul 06, 2020
Deep Recon
K193073 · JAK
Shanghai United Imaging Healthcare...
Radiology · 245d
Cleared Jul 01, 2020
syngo.via View&GO
K201477 · LLZ
Siemens Healthcare GmbH
Radiology · 28d
Cleared Jul 01, 2020
StimPlus Patch, StimPlus Patch, StimPlus Patch
K200561 · NUH
Jkh Health Co., Ltd.
Neurology · 119d
Cleared Jun 30, 2020
Altapore MIS
K201464 · MQV
Baxter Healthcare Corporation
Orthopedic · 28d
Cleared Jun 26, 2020
DRX-Compass
K201373 · KPR
Carestream Health, Inc.
Radiology · 31d
Cleared Jun 25, 2020
FiteBac Antimicrobial Cavity Cleanser
K200614 · LBH
Largent Health, LLC
Dental · 108d
Cleared Jun 24, 2020
Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum
K200975 · HGM
Huntleigh Healthcare Limited
Obstetrics & Gynecology · 72d
Cleared Jun 24, 2020
Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve
K200495 · ODC
Ga Health Company Limited
Gastroenterology & Urology · 117d