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

5,277 results for "health"
1321–1344 of 5,277
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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
Cleared Mar 23, 2018
Drive DeVilbiss iGo 2 Portable Oxygen Concentrator
K172648 · CAW
Devilbiss Healthcare, LLC
Anesthesiology · 203d
Cleared Mar 20, 2018
Philips Incisive CT
K180015 · JAK
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 77d
Cleared Mar 16, 2018
3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System
K180404 · NJM
3M Healthcare
Dental · 30d
Cleared Mar 13, 2018
Voluson S8/ Voluson S10/ Voluson S10 Expert
K180374 · IYN
Ge Healthcare
Radiology · 29d
Cleared Mar 08, 2018
ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws,...
K171320 · HRS
Meril Healthcare Pvt. , Ltd.
Orthopedic · 308d
Cleared Mar 07, 2018
ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)
K171802 · NUH
Bayer Healthcare, LLC
Neurology · 261d
Cleared Mar 06, 2018
Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter
K173262 · OWQ
Innovative Health, LLC
Cardiovascular · 146d
Not Cleared Mar 06, 2018
23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)
DEN170046 · QAZ
23AndMe, Inc.
Pathology · 182d
Cleared Mar 02, 2018
uCT Computed Tomography X-ray System
K172135 · JAK
Shanghai United Imaging Healthcare...
Radiology · 231d