13 results
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26ms
·
Sources: EU EUDAMED, US FDA
PROCAST
FDA 510(k)
FDA Class 1
·Physical Medicine
CALCIUM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MobiliT Cup
FDA 510(k)
FDA Class 2
·Orthopedic
IMMULITE 1000 TURBO TROPONIN 1
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS·Product code MMI·May 6, 2014
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·October 15, 2012
CONTOUR CURVED CUTTER STAPLER
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC·Product code GDW·August 5, 2010
NEURO SPG-1X1"-STERILE- 20/CS
FDA Adverse Event
Malfunction
·MEDSORB DOMINICANA, S.A.·Product code EFQ·February 20, 2025
NEURO SPNG-1/2X3"-STRL- 20/CS
FDA Adverse Event
Malfunction
·MEDSORB DOMINICANA, S.A.·Product code EFQ·January 20, 2025
NEURO-SP-1/2X1/2"-STRL 20/CS
FDA Adverse Event
Malfunction
·MEDSORB DOMINICANA, S.A.·Product code EFQ·January 20, 2025
NEURO-SP-1/2X1/2"-STRL 20/CS
FDA Adverse Event
Malfunction
·MEDSORB DOMINICANA, S.A.·Product code EFQ·January 20, 2025
NEURO-SP-1/2X1/2"-STRL 20/CS
FDA Adverse Event
Malfunction
·MEDSORB DOMINICANA, S.A.·Product code EFQ·February 7, 2025
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
Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024