16 results · 23ms · Sources: EU EUDAMED, US FDA

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CD HORIZON™ Spinal System

FDA 510(k)
FDA Class 2 ·Orthopedic

B-P TOTAL HIP SYSTEM

FDA UDI
ENDOTEC, INC.·00814193023599·B-P HIP SELF-ALIGNING ACETABULAR CUP & BEARING ...

NITRILE CORNFLOWER BLUE POWDER-FREE EXAMINATION GLOVES WITH TESTED FOR USE WITH CHEMOTHERAPY DRUG LABELING CLAIM

FDA 510(k)
FDA Class 1 ·General Hospital

SOLARIS NT1 AND NT1A HANDHELD PULSE OXIMETERS WITH SENSOR ACCESSORIES

FDA 510(k)
FDA Class 2 ·Cardiovascular

T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code OZO·June 5, 2019

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 15, 2014

FINELINE II

FDA Adverse Event
Malfunction ·CPI - DEL CARIBE·Product code NVN·July 23, 2011

CORFLO ULTRA NG 8FR

FDA Adverse Event
Malfunction ·CORPAK MEDSYSTEMS·Product code KNT·June 6, 2013

BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code DQO·January 18, 2019

BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER

FDA Adverse Event
Injury ·COOK INC·Product code DQO·November 26, 2019

AXIUM PRIME BRPL 3D

FDA Adverse Event
Death ·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·June 8, 2022

AXIUM PRIME BRPL 3D

FDA Adverse Event
Death ·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·June 8, 2022

RIST RADIAL ACCESS CATHETER

FDA Adverse Event
Death ·MICRO THERAPEUTICS, INC. DBA EV3·Product code QJP·June 8, 2022

BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER

FDA Adverse Event
Injury ·COOK INC·Product code DQO·November 26, 2025

AXIUM PRIME BRPL 3D

FDA Adverse Event
Death ·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·June 8, 2022

Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only. The AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. Part number: V000172

FDA Enforcement
Class II ·Terminated·Vision RT Ltd·October 10, 2018