16 results
·
21ms
·
Sources: EU EUDAMED, US FDA
GEMENI CK-MB ISOENZYME ABNORMAL SERUM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
APLIO DIAGNOSTIC ULTRASOUND SYSTEM; APLIO DIAGNOSTIC ULTRASOUND SYSTEM; APLIO DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
LAP DISC 120 X 120, MODEL LD111, LAP DISC 120 X 100, MODEL LD112, LAP DISC 70 X 70, MODEL LD113
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·October 2, 2007
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 9, 2014
MAXIMO VR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·October 31, 2012
BONE SCR 6.5X35 SELF-TAP
FDA Adverse Event
Injury
·ZIMMER MANUFACTURING B.V.·Product code LPH·November 27, 2019
ACT ARTIC E1 HIP BRG 28X42MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·November 27, 2019
G7 PPS LTD ACET SHELL 52E
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PBI·November 27, 2019
G7 DUAL MOBILITY LINER 42MM E
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·November 27, 2019
CABLE CERCLAGE CABLE WITH CRIMP 1.8 MM DIA. 635 MM LENGTH
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KTT·November 27, 2019
ARCOS 15X150MM SPL TPR DIST
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·November 27, 2019
ACT ARTIC E1 HIP BRG 28X42MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·November 26, 2019
ARCOS CON SZ B STD 70MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·November 27, 2019
CER BIOLOXD MOD HD 28MM STD NK
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·November 25, 2019
Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·September 30, 2015