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"
1609–1632 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Aug 31, 2015
Biogel PI Micro Indicator Underglove
K150146 · KGO
Molnlycke Health Care Us, LLC
General Hospital · 221d
Cleared Aug 20, 2015
HealthMyne PACS
K152186 · LLZ
Healthmyne, Inc.
Radiology · 15d
Cleared Aug 18, 2015
Full Automatic (NIBP)Blood Pressure Monitor
K150311 · DXN
Health & Life Co., Ltd.
Cardiovascular · 190d
Cleared Aug 14, 2015
Transcutaneous Electrical Nerve Stimulators (TENS)
K150043 · NUH
Andon Health Co, Ltd.
Neurology · 217d
Cleared Jul 31, 2015
B40i Patient Monitor
K143676 · MHX
GE Healthcare Finland Oy
Cardiovascular · 219d
Cleared Jul 17, 2015
CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV,...
K150245 · CCK
GE Healthcare Finland Oy
Anesthesiology · 165d
Cleared Jul 17, 2015
ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA...
K143687 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 205d
Cleared Jul 17, 2015
UltraLinq
K143176 · LLZ
Ultralinq Healthcare Solutions, Inc.
Radiology · 255d
Cleared Jul 10, 2015
SIGNA Pioneer
K143345 · LNH
Ge Healthcare Japan Corporation
Radiology · 231d
Cleared Jul 02, 2015
MicroScan Dried Gram Positive MIC/Combo Panels with vancomycin (0.25-64 mcg/mL)
K150039 · LTT
Siemens Healthcare Diagnostics, Inc.
Microbiology · 174d
Cleared Jun 30, 2015
AGE Automatic Wrist Blood Pressure Monitor
K151281 · DXN
Dongguan Ageless Health Industrial...
Cardiovascular · 47d
Cleared Jun 30, 2015
Besmed Reusable Jet Nebulizer
K150591 · CAF
Besmed Health Business Corp
Anesthesiology · 113d
Cleared Jun 27, 2015
Proteus Digital Health Feedback Device
K150494 · OZW
Proteus Digital Health, Inc.
Gastroenterology & Urology · 122d
Cleared Jun 25, 2015
CRYOCARE CS SURGICAL SYSTEM
K141110 · GEH
Healthtronics
General & Plastic Surgery · 422d
Cleared Jun 24, 2015
Carestream DRX-1 System
K150766 · MQB
Carestream Health, Inc.
Radiology · 92d
Cleared Jun 23, 2015
Merits Yoga Power Scooter, S542
K142912 · INI
Merits Health Products Co., Ltd.
Physical Medicine · 260d
Cleared Jun 18, 2015
Fusion Black Powder-Free Nitrile Exam Glove
K150113 · LZA
Halyard Health
General Hospital · 149d
Cleared Jun 15, 2015
Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista...
K140790 · JIX
Siemens Healthcare Diagnostics
Chemistry · 441d
Cleared Jun 08, 2015
smARTrack Feeding Tube System
K142327 · KNT
Art Healthcare , Ltd.
Gastroenterology & Urology · 292d
Cleared Jun 01, 2015
PROBEAT-V
K151132 · LHN
Hitachi, Ltd., Health Care Company
Radiology · 34d
Cleared Jun 01, 2015
ICIS View
K143397 · LLZ
Agfa Healthcare N.V.
Radiology · 187d
Cleared May 27, 2015
SpiroThor
K150137 · BZG
Cohero Health, LLC
Anesthesiology · 125d
Cleared May 26, 2015
Centricity Universal Viewer
K150420 · LLZ
Ge Healthcare
Radiology · 97d
Cleared May 26, 2015
Oral7 Moisturizing Gel, Oral7 Moisturizing Mouthwash, Oral7 Moisturizing...
K142549 · LFD
J.C.E.C. Company, Inc. (Doing...
Dental · 258d