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

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SUSTAIN

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCH

FDA 510(k)
FDA Class 2 ·Cardiovascular

MED-TEC 6 DEGREE AXIS COUCH, MODEL MT-6DAC

FDA 510(k)
FDA Class 2 ·Radiology

ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

FDA Adverse Event
Injury ·CODMAN AND SHURTLEFF, INC·Product code NJE·September 15, 2017

ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

FDA Adverse Event
Injury ·CODMAN AND SHURTLEFF, INC·Product code NJE·September 15, 2017

ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

FDA Adverse Event
Injury ·CODMAN AND SHURTLEFF, INC·Product code NJE·September 15, 2017

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 1, 2014

APTIO CENTRIFUGE MODULE

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code JJE·May 29, 2013

MINI TREK CORONARY DILATATION CATHETER

FDA Adverse Event
Malfunction ·AV-TEMECULA-CT·Product code LOX·June 16, 2011

BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC)

FDA Adverse Event
Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·March 10, 2023

ENDOWRIST

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·July 16, 2020

Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)

FDA Enforcement
Class II ·Ongoing·Medtronic Inc.·November 29, 2017

Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

FDA Enforcement
Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015