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"
1009–1032 of 5,276
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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
Cleared Jun 19, 2020
Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue...
K200671 · LZA
Ansell Healthcare Products, LLC
General Hospital · 98d
Cleared Jun 18, 2020
Andorate Biopsy Valve, Andorate Biopsy Irrigator
K200481 · ODC
Ga Health Company Limited
Gastroenterology & Urology · 112d
Cleared Jun 12, 2020
Full Automatic(NIBP) Blood Pressure Monitor
K200521 · DXN
Health & Life Co., Ltd.
Cardiovascular · 102d
Cleared Jun 11, 2020
uWS-MI
K192630 · LLZ
Shanghai United Imaging Healthcare...
Radiology · 262d
Cleared Jun 05, 2020
Spire Health Remote Patient Monitoring System
K192952 · MSX
Spire, Inc. D/B/A Spire Health
Cardiovascular · 228d
Cleared Jun 04, 2020
Livongo Blood Glucose Monitoring System (BG1000)
K200277 · NBW
Livongo Health, Inc.
Chemistry · 121d
Cleared Jun 03, 2020
QLAB Advanced Quantification Software
K200974 · QIH
Philips Health Care
Radiology · 51d
Cleared Jun 02, 2020
F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora...
K200089 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 139d
Cleared Jun 01, 2020
uWS-MR
K192601 · QIH
Shanghai United Imaging Healthcare...
Radiology · 255d