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