19 results
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24ms
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Sources: EU EUDAMED, US FDA
PCA ACETABULAR INSERT II, ADDITIONAL SIZES, STYLES
FDA 510(k)
FDA Class 3
·Orthopedic
INJECTION AIDE UNIT FOR DIAGETICS
FDA 510(k)
FDA Class 2
·General Hospital
LOCAL PLEXUS BLOCK ANESTHESIA CATHETER KITS
FDA 510(k)
FDA Class 2
·Anesthesiology
CHAMBER COMPLETE AUTOFEED 900
FDA Adverse Event
Malfunction
·Product code BTT·May 5, 2021
CHAMBER COMPLETE AUTOFEED 900
FDA Adverse Event
Malfunction
·Product code BTT·January 21, 2020
NATURALYTE
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 27, 2014
LANX SPINAL FIXATION SYSTEM
FDA Adverse Event
Malfunction
·LANX, INC.·Product code MNI·November 23, 2010
CHARGING SYSTEM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·January 28, 2013
VENTED HUMIDIFICATION CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·July 17, 2023
VENTED AUTOFEED HUMIDIFICATION CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·February 20, 2023
VENTED AUTOFEED HUMIDIFICATION CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·January 23, 2024
COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code PAO·May 5, 2017
COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY WITH LOCKING RING
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWS·May 5, 2017
COMPREHENSIVE REVERSE SHOULDER E1 HUMERAL BEARING
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code PAO·May 5, 2017
CHAMBER COMPLETE AUTOFEED 900
FDA Adverse Event
Malfunction
·Product code BTT·June 3, 2021
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·May 15, 2024
CHAMBER COMPLETE AUTOFEED 900
FDA Adverse Event
Malfunction
·Product code BTT·February 4, 2021
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