30 results
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24ms
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Sources: EU EUDAMED, US FDA
NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE /FLUID WARMER DRAPE,SKIRTED
FDA 510(k)
FDA Class 1
·Physical Medicine
VascuTrak®
FDA UDI
Bard Peripheral Vascular, Inc.·00801741061110·VascuTrak® PTA Dilatation Catheter 2 mm x 80 mm...
Preat
FDA UDI
Preat Corporation·00842092135785·Equator Abutment for Nobel Active/Conical RP x ...
DEPUY RECLAIM REVISION HIP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TRACKEASE SMART SYSTEM BLOOD GLUCOSE SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Magna-Fx®
FDA UDI
Zimmer, Inc.·00889024025448·
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 4, 2014
EON MINI
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 28, 2013
VITROS CHEMISTRY PRODUCTS PHBR SLIDES
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code DIP·June 28, 2011
OHICHO3
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·August 30, 2022
OHICHO3
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·March 18, 2026
IMP,TSV,4.1MM,DUAL SEL,HA
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·February 5, 2024
METACROSS OTW PTA BALLOON DILATATION CATHETER
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·August 19, 2019
IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·February 5, 2024
OHICHO NEO
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·February 7, 2024
OSTEOVATION RMX Injectable BVF 5CC . REF/UDI: 390-6001/ /00813845021082 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
FDA Enforcement
Class II
·Terminated·Osteomed, LLC·June 10, 2020
OHICHO3
FDA Adverse Event
Injury
·Product code LIT·December 26, 2019
SHIRANUI EX
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·August 12, 2020
OHICHO3
FDA Adverse Event
Injury
·Product code LIT·July 19, 2019
PTA BALLOON CATHETER(OHICHO3)
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·December 13, 2017