14 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SeaSpine Meridian System, SeaSpine Meridian Anterior Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
Zavation
FDA UDI
Zavation LLC·00842166132955·Ti3Z CIF 14mmx16mmx11mm -7 deg
ZAVATION
FDA UDI
Zavation LLC·00842166105041·CIF 14x16, 7 deg, -11
ACCU-CHEK ® INSIGHT FLEX
FDA Adverse Event
Malfunction
·ROCHE DIABETES CARE, INC.·Product code FPA·August 16, 2018
WALLACH LOOP ELECTRODE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NON-CONTACT THERMOMETER
FDA 510(k)
FDA Class 2
·General Hospital
BD LUER-LOK TIP SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·September 9, 2019
SYRINGE 60ML LL TIP 1ML 2 OZ IN 1/4 OZ
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·September 5, 2019
K 520711-2, Hercep Test, 35Test, HER2, Protein
FDA Recall
Terminated
·Dakocytomation California Inc·Product code MVC·September 29, 2005
OT ULTRAMINI METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·August 23, 2011
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·November 3, 2014
IMPAX CV REPORTING
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP.·Product code LLZ·July 8, 2013
MARA PROBE
FDA Adverse Event
Malfunction
·COOPERSURGICAL, INC.·Product code MNB·February 10, 2023
Remel Haemophilus Test Medium(100mm) 10/PK, REF: R01503 Remel Haemophilus Test Medium (HTM) is a solid medium recommended for use in qualitative procedures by the Clinical and Laboratory Standards Institute (CLSI) as the growth medium for antimicrobial disk diffusion tests with Haemophilus species.
FDA Enforcement
Class II
·Ongoing·Remel Inc·April 21, 2021