16 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617)
FDA 510(k)
FDA Class 2
·Physical Medicine
Nano Silver Care Toothbrush
FDA UDI
SAFCO DENTAL SUPPLY CO.·10810063756625·Nano Silver Care Toothbrush, silver-infused ult...
Vivid ZirDisc Amman Girrbach System
FDA UDI
PEARSON DENTAL SUPPLIES, INC.·D724Q2500461·89x71x16mm 03HT (Translucent)
COE®
FDA UDI
Gc America Inc.·10386040012782·SHELF SPACER TRAY #4D PERF
COE®
FDA UDI
Gc America Inc.·20386040012789·SHELF SPACER TRAY #4D PERF
Darby Dental Supply, LLC
FDA UDI
DARBY DENTAL SUPPLY, LLC·00889813010587·NITI LEGACY MT CM F4 31MM
Stainless Steel Rectangular Wire
FDA UDI
Ortho Arch Company Inc·D90925004614·.016 X .016 STAINLESS STEEL RECTANGULAR 14' LEN...
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011250046400·ceraMotion® Zr Dentin B1, 40 g / dental ceramic...
Evolve
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215002510·
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011250046200·ceraMotion® Zr Dentin B1, 20 g / dental ceramic...
Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
REHABILICARE IF 3 WAVE INTERFERENTIAL STIMULATOR SYSTEM, MODEL 7110S
FDA 510(k)
FDA Class 2
·Physical Medicine
BATTERY FOR POWER DRIVE
FDA Adverse Event
Malfunction
·SYNTHES OBERDORF·Product code MOQ·November 14, 2014
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·September 9, 2011
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·July 26, 2013
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013