14 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Huber Needle Infusion Set, Safety Huber Needle Infusion Set
FDA 510(k)
FDA Class 2
·General Hospital
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613154131754·CHEEK RETRACTOR, ADJUSTABLE
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450021972·
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319742716·Hohmann Retractor 9-1/4" (23.1cm), blade 18mm wide
JMY - 3 MEMBRANE REPAIR INSTR.
FDA UDI
W.H. Holden, Inc.·D9282004630·
ACUMED
FDA UDI
Acumed LLC·10806378014321·3.5mm x 45.0mm Locking Cortical Screw
ACUMED
FDA UDI
Acumed LLC·10806378014338·3.5mm x 45.0mm Locking Cortical Screw
IMMULITE H. PYLORI IGG AND IMMULITE 2000 H. PYLORI IGG
FDA 510(k)
FDA Class 1
·Microbiology
DEPILASE YAG LASE PLUS LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
UNK DEEP BRAIN STIMULATOR
FDA Adverse Event
Death
·MEDTRONIC NEUROMODULATION·Product code MHY·March 22, 2009
ICENTRAL
FDA Adverse Event
GE HEALTHCARE FINLAND OY·Product code MSX·October 6, 2008
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 1, 2013
Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.
FDA Enforcement
Class II
·Terminated·Bayer Corp·June 11, 2014