10 results
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39ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Pyrenees Cervical Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
HEMA SCREEN ER
FDA 510(k)
FDA Class 2
·Hematology
HUMIDCARE HEATED HUMIDIFIER, MODEL 9S-004
FDA 510(k)
FDA Class 2
·Anesthesiology
PENUMA IMPLANT
FDA Adverse Event
Injury
·INTERNATIONAL MEDICAL DEVICES, INC.·Product code MIB·October 7, 2019
GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 4+ LEFT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·April 21, 2017
GYNECARE TVT RETROPUBIC SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·June 11, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 14, 2011
ITREL II
FDA Adverse Event
Death
·MEDTRONIC NEUROMODULATION·Product code MHY·September 16, 2008
BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·October 22, 2019
OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02-35, 35MM; e) 200-02-38, 38MM; f) 200-02-41, 41MM;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·June 26, 2024