13 results · 26ms · Sources: EU EUDAMED, US FDA

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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