10 results
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18ms
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Sources: EU EUDAMED, US FDA
INNERWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
HIM TEST COCAINE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
MODIFICATION TO TSRH SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SS COMPRESSION HIP SCREW LAG SCREW
FDA Adverse Event
Injury
·BIOMET TRAUMA·Product code KTT·September 19, 2016
ARTICULEZE M HEAD 36MM +5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910 ·Product code JDI·February 21, 2013
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·August 1, 2014
PFC SIGMA TC3 FEM RT SZ5
FDA Adverse Event
Injury
·DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code JWH·January 26, 2011
PECTUS SYSTEM JANTON 12" TI PECTUS BAR 3.048CM (12") (L) TITANIUM
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HRS·January 2, 2019
Covidien Trellis-8 Peripheral Infusion System. Models CVT808015, CVT808025, CVT812015, and CVT812025. The following models are not offered for sale in the US: EVT808015, EVT808025, EVT812015, and EVT812025 Sterile EO. Product Usage: Intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
FDA Enforcement
Class I
·Terminated·Covidien·February 11, 2015
Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT612030V01, CVT808015, CVT808025, CVT812015, CVT812025, EVT808015, EVT808025, EVT812015, EVT812025, BVT808015, BVT808030, BVT812015, BVT812030, EUT808015, EUT808030, EUT812015, EUT812030. Product Usage: The Trellis 6 and Trellis 8 peripheral infusion system is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
FDA Enforcement
Class II
·Terminated·Medtronic Inc. Cardiac Rhythm Disease Management·April 8, 2015