20 results
·
41ms
·
Sources: EU EUDAMED, US FDA
RAICHEM RHEUMATOID FACTOR SPIA
FDA 510(k)
FDA Class 2
·Immunology
artegral
FDA UDI
Merz Dental GmbH·D7091970373·anteriors; shade C4; mould UBS
APOZA LED CURING LIGHT, MODEL E-MORLIT, D-2000, TOP 3W, TOP 5W
FDA 510(k)
FDA Class 2
·Dental
Flextra Steerable Introducer
FDA 510(k)
FDA Class 2
·Cardiovascular
ILAB ULTRASOUND IMAGING SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - FREMONT (CE)·Product code OBJ·February 20, 2013
MICRO DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code HBE·January 18, 2011
PFC SIGMARP STB TB IN 4 10.0
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code NJL·July 31, 2014
Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 5, 15.0 mm; Ref 97-0373.
FDA Recall
Terminated
·Depuy Orthopaedics, Inc.·Product code JWH·May 26, 2005
BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS
FDA Adverse Event
Injury
·BECTON DICKINSON CARIBE LTD.·Product code MDB·August 16, 2023
BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·August 16, 2023
BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·March 20, 2023
BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·December 1, 2021
BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·January 11, 2023
BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·April 4, 2023
BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·March 20, 2024
BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·September 9, 2022
BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·July 8, 2022
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·April 28, 2016
BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·February 1, 2022
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022