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"
1297–1320 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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
Cleared Feb 28, 2018
ALOKA ARIETTA 850
K173739 · IYN
Hitachi Healthcare Americas Corporation
Radiology · 83d
Cleared Feb 23, 2018
Prismaflex System 8.10
K171671 · KDI
Baxter Healthcare Corporation
Gastroenterology & Urology · 262d
Cleared Feb 13, 2018
Infra-red ear thermometer model: ET-100A, ET-100B, ET-100D, ET-100E, ET-100G,...
K172870 · FLL
Hangzhou Hua'An Medical&Health...
General Hospital · 146d
Cleared Feb 06, 2018
Gammex PI Breach Detect Powder Free Surgical Glove
K171375 · KGO
Ansell Healthcare Products, LLC
General Hospital · 272d
Cleared Feb 05, 2018
DRX-Revolution Nano Mobile X-ray System
K173924 · IZL
Carestream Health, Inc.
Radiology · 41d
Cleared Jan 26, 2018
Mic-Key* SF Over-the-Wire Stoma Measuring Device
K173955 · KNT
Halyard Health, Inc.
Gastroenterology & Urology · 29d
Cleared Jan 26, 2018
uDR 780i
K173953 · KPR
Shanghai United Imaging Healthcare...
Radiology · 30d
Cleared Jan 26, 2018
SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE...
K171367 · LYY
Sanrea Healthcare Products Pvt, Ltd.
General Hospital · 262d
Cleared Jan 25, 2018
F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version
K173060 · CBK
Fisher and Paykel Healthcare Limited
Anesthesiology · 119d
Cleared Jan 19, 2018
OnSight 3D Extremity System
K173478 · JAK
Carestream Health, Inc.
Radiology · 67d
Cleared Jan 12, 2018
ImagenUniversal
K173547 · KPS
Cardiovascular Imaging Technologies
Radiology · 57d
Cleared Jan 11, 2018
Besmed Peak Flow Meter
K172804 · BZH
Besmed Health Business Corp
Anesthesiology · 115d
Cleared Jan 11, 2018
ECHELON OVAL V6.0A MRI System
K172110 · LNH
Hitachi Healthcare Americas Corporation
Radiology · 182d
Cleared Jan 08, 2018
Pristeen (Latex Surgeon’s Gloves Powder Free, Polymer coated with protein...
K172942 · KGO
Beta Healthcare Products Pvt., Ltd.
General Hospital · 104d
Cleared Jan 02, 2018
Snorer's Friend
K171529 · LRK
Scope Healthcare Technologies Pty, Ltd.
Dental · 222d