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

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PRIME-XV FreezIS DMSO-Free MD

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

MILAGRO

FDA UDI
Medos International Sàrl·10886705010721·MILAGRO INTERFERENCE SCREW Absorbable - TCP/PLG...

COMPRESS DISTAL FEMORAL REPLACEMENT

FDA 510(k)
FDA Class 2 ·Orthopedic

REMEL XPECT FLU A&B

FDA 510(k)
FDA Class 1 ·Microbiology

DEPUY MITEK MILAGRO INTERFERENCE SCREW MODEL 231803, 231804, 231807, 231809

FDA 510(k)
FDA Class 2 ·Orthopedic

COCHLEAR OSIA OSI300 IMPLANT

FDA Adverse Event
Injury ·COCHLEAR LTD·Product code PFO·March 8, 2026

COCHLEAR OSIA OSI300 IMPLANT

FDA Adverse Event
Injury ·COCHLEAR LTD·Product code PFO·January 15, 2024

RESTORE ULTRA

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·March 17, 2015

COCHLEAR OSIA OSI300 IMPLANT

FDA Adverse Event
Injury ·COCHLEAR LIMITED·Product code PFO·January 15, 2024

RESTORE ULTRA

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·August 3, 2012

SENSOR ENLITE

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OZO·November 6, 2014

COLLEAGUE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011

TRUERESULT

FDA Adverse Event
Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·July 15, 2013

MILAGRO INSCR SMALL SIZE 5X30

FDA Adverse Event
Malfunction ·DEPUY MITEK LLC US·Product code MAI·December 5, 2018

RESTORE ULTRA

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·December 18, 2012

VariCam

FDA Enforcement
Class II ·Completed·GE Healthcare, LLC·January 16, 2019

Revogene, Catalog no. 610210. IVD test instrument

FDA Enforcement
Class II ·Ongoing·Meridian Bioscience Inc·August 3, 2022

Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024