8 results
·
20ms
·
Sources: EU EUDAMED, US FDA
BALANCEBACK MOBILE INTUITIVE VNG SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
AGILENT ELECTRONIC STETHOSCOPE, MODELS M4532A AND M4533A
FDA 510(k)
FDA Class 2
·Cardiovascular
ARROW ULTRA 8 INTRA-AORTIC BALLOON CATHETERS (IABS) 8FR 30CC AND 40CC UNIVERSAL
FDA 510(k)
FDA Class 2
·Cardiovascular
SM104 MSERIES W5TH WHLOBS3/07
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·April 22, 2013
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·April 14, 2011
THAL-QUICK CHEST TUBE SET
FDA Adverse Event
Malfunction
·COOK, INC.·Product code DQR·July 2, 2008
MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·September 8, 2024
Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·November 9, 2016