17 results
·
21ms
·
Sources: EU EUDAMED, US FDA
LG Pra. L Derma LD Scalp Care
FDA 510(k)
FDA Class 2
·Physical Medicine
Blade Scalpel
FDA UDI
KATENA PRODUCTS, INC.·00841668113479·MINIATURE BLADE #64 (BX/5)
JACOBSON HEMOSTATIC FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896060937·JACOBSON HEMOSTATIC FORCEPS DELICATE STRAIGHT TIP
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450155363·
Sonoma™
FDA UDI
Seaspine Orthopedics Corporation·10889981050979·Sonoma Anterior Cervical Plate 4 Level Plate, 64mm
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319706053·Hohmann Retractor 9-1/4" (23.1cm), blade 25mm wide
ACUMED
FDA UDI
Acumed LLC·10806378014345·3.5mm x 50.0mm Locking Cortical Screw
Portex
FDA UDI
ICU MEDICAL, INC.·15019517070606·
ACUMED
FDA UDI
Acumed LLC·10806378014352·3.5mm x 50.0mm Locking Cortical Screw
SANIDAD FAR-INFRARED MINI LAMP, MODEL FI-3646
FDA 510(k)
FDA Class 2
·Physical Medicine
URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 90A
FDA 510(k)
FDA Class 2
·Clinical Toxicology
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
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 1, 2013
OT ULTRAMINI METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 17, 2012
OT ULTRAMINI METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 17, 2012
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