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"
1345–1368 of 5,277
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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
Cleared Dec 29, 2017
Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves
K171737 · LZA
Ansell Healthcare Products, LLC
General Hospital · 200d
Cleared Dec 26, 2017
Real Time Image Gating System for Proton Beam Therapy Systems
K171049 · LHN
Hitachi, Ltd. Healthcare
Radiology · 263d
Cleared Dec 20, 2017
LOGIQ E10
K173555 · IYN
Ge Healthcare
Radiology · 33d
Cleared Dec 20, 2017
Electric Breast Pump
K172989 · HGX
Joytech Healthcare Co. , Ltd.
Obstetrics & Gynecology · 84d
Cleared Dec 19, 2017
Digital thermometer(with disposable thermometer cover)
K172861 · FLL
Hangzhou Hua'An Medical&Health...
General Hospital · 90d
Cleared Dec 18, 2017
Automated Blood Coagulation Analyzer CS-2500
K172286 · JPA
Siemens Healthcare Diagnostic...
Hematology · 143d
Cleared Dec 08, 2017
Merge PACS
K173475 · LLZ
Merge Healthcare Incorporated
Radiology · 29d
Cleared Dec 04, 2017
ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay
K171771 · PDJ
Siemens Healthcare Diagnostics, Inc.
Chemistry · 173d
Cleared Nov 30, 2017
Destiknee™ Total Knee System
K172936 · JWH
Meril Healthcare Pvt. , Ltd.
Orthopedic · 65d