13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Neodent Implant System - Zirconia Implant System
FDA 510(k)
FDA Class 2
·Dental
MILAGRO
FDA UDI
Medos International Sàrl·10886705010714·MILAGRO INTERFERENCE SCREW Absorbable - TCP/PLG...
DEPUY CERAMIC FEMORAL HEADS
FDA 510(k)
FDA Class 2
·Orthopedic
GUARDIAN URETHRAL SHEATH
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DEPUY MITEK MILAGRO INTERFERENCE SCREW MODEL 231803, 231804, 231807, 231809
FDA 510(k)
FDA Class 2
·Orthopedic
MILAGRO
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code MAI·April 30, 2026
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 1, 2011
*
FDA Adverse Event
Malfunction
·*·Product code KSZ·August 18, 2008
PLV-100
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·July 15, 2013
MILAGRO INSCR SMALL SIZE 5X23
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code MAI·January 21, 2019
MILAGRO INSCR SMALL SIZE 5X23
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code MAI·July 30, 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