11 results
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19ms
·
Sources: EU EUDAMED, US FDA
EMDS ALKANINE PHOSPHATASE (ALP) TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SIC invent Dental Implant Systems
FDA UDI
SIC invent AG·ESIC9351821·SICace Screw Implant Ø 3.4 mm / 7.5 mm incl. Co...
PLIF Allograft
FDA UDI
Seaspine Orthopedics Corporation·10889981090647·Temporary Post Fixation Pin - Long
OSCOR MEDICAL CORP. PERMANENT PACING PAD
FDA 510(k)
FDA Class 3
·Cardiovascular
DEROYAL HYDROGEL DRESSING
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP.·Product code FRN·February 3, 2014
BIOCOMPOSITE PUSHLOCK, 3.5MM X 19.5MM
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code MAI·December 22, 2010
TOTALCARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·December 21, 2012
ev3 Pipeline Flex Embolization Device. For neurological endovascular use.
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·April 1, 2020
Various products which were contract sterilized.
FDA Enforcement
Class II
·Ongoing·Anewmed Corporation·November 6, 2019
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015