21 results · 24ms · Sources: EU EUDAMED, US FDA

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Pointe Scientific Creatinine Kinase (CK) Reagent Set

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Bernafon

FDA UDI
Bernafon AG·05711584086308·ZR1 MNR, 2.4G NFM PB MAC ZERENA 1

ZIMMER SEGMENTAL SYSTEM PROXIMAL FEMORAL COMPONENT AND SMALL DIAMETER STEM EXTENSIONS

FDA 510(k)
FDA Class 2 ·Orthopedic

POLYTEL GMA, MODELS PWR-08-67, PWR-08-07, PWR-08-09

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

CONTOUR® PLUS

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·September 10, 2025

CONTOUR® XT

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·April 23, 2026

HARMONIC ACE 36 CM

FDA Adverse Event
Malfunction ·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code LFL·October 9, 2008

SROM*STM ST,36+8L NK,18X13X160

FDA Adverse Event
Injury ·9616671 DEPUY IRELAND·Product code JDI·June 26, 2013

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code MDS·July 28, 2011

CONTOUR® PLUS

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 1, 2026

CONTOUR® XT

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 15, 2025

CONTOUR® PLUS

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·December 31, 2025

CONTOUR® NEXT

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 12, 2026

CONTOUR® PLUS

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·September 11, 2025

CONTOUR® PLUS

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·October 8, 2025

BIO-COMP SWIVELOCK C, CLD 5.5X19.1MM

FDA Adverse Event
Injury ·ARTHREX, INC.·Product code MAI·April 22, 2020

CONTOUR® PLUS

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·December 1, 2023

CONTOUR® PLUS

FDA Adverse Event
Injury ·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 15, 2025

CONTOUR® PLUS

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·November 4, 2025

TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems·October 10, 2018