12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic)
FDA 510(k)
FDA Class 1
·Microbiology
BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC)
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·October 18, 2021
Leukomed®
FDA UDI
BSN medical GmbH·04042809595383·LEUKOMED SKIN SENSITIVE STERILE 10X25CM WHITE 20
CONGRUENT BONE PLATE SYSTEM: ACU-LOC 2 PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
WILSON-COOK ENDOSCOPIC CLIPPING DEVICE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MAIN PCB (ASTRAL 150) - 90HPA
FDA Adverse Event
Malfunction
·RESMED LTD·Product code CBK·November 4, 2020
EQUINOXE REVERSE SHOULDER COMPONENTS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·August 31, 2023
PROSTAR XL SUTURE-MEDIATED CLOSURE
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·May 22, 2013
GYNECARE X-TRACT MORCELLATOR
FDA Adverse Event
Malfunction
·ETHICON·Product code HET·June 14, 2011
ACCU-CHEK MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·August 15, 2008
MDA Simplastin L, Product number 252555, 10 vials, 40 ml ea (400 test each), bioMerieux Inc., Box 15969 Durham, North Carolina 27704-0969.
FDA Recall
Terminated
·bioMerieux·Product code GJS·July 31, 2003
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
FDA Enforcement
Class I
·Ongoing·Covidien·November 8, 2023