9 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Streamline 6495 Bipolar Temporary Myocardial Pacing Lead
FDA 510(k)
FDA Class 2
·Cardiovascular
AXSYM DIGOXIN III
FDA 510(k)
FDA Class 2
·Clinical Toxicology
STERIGAGE MODEL 1243RA, 1243RB, 1243RE
FDA 510(k)
FDA Class 2
·General Hospital
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013
FLEXTEND II
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVN·July 13, 2011
PROGENIX DBM PUTTY
FDA Adverse Event
Injury
·APPTEC LABORATORY SERVICES·Product code MBP·September 11, 2008
ONE TOUCH ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·May 29, 2009
Jackson-Pratt Silicone Flat Drain, 10mm, Full Ducts. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·May 31, 2017
dS Breast 7ch 3.0T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 4, 2024