10 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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UNITRAX V40 MODULAR ADAPTOR
FDA 510(k)
FDA Class 2
·Orthopedic
MIX EVAC II
FDA 510(k)
FDA Class 1
·Orthopedic
OSSIOfiber® Threaded Trimmable Fixation Nail
FDA 510(k)
FDA Class 2
·Orthopedic
OPT BLADELESS 5X100 STABILITY
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·February 11, 2013
VENTAK PRIZM
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 10, 2011
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·July 23, 2014
Remel, Haemophilus Test Medium (Agar) in A) 100 mm REF R01503, and B) 150 mm plates REF R04033,
FDA Recall
Terminated
·Remel Inc·Product code LKA·February 9, 2017
Oxoid Gentamicin Antimicrobial Susceptibility Testing Disc (CN10), REF# CT0024B packaged in packs of 5 cartridges - 50 disc/cartridge. Used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes.
FDA Recall
Terminated
·Remel Inc·Product code JTN·November 6, 2015
Remel Haemophilus Test Medium (150 mm) 10/PK, REF 04033 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 Recall
Open, Classified
·Remel Inc·Product code JSO·March 10, 2021
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 Recall
Open, Classified
·Remel Inc·Product code JSO·March 10, 2021