19 results · 24ms · Sources: EU EUDAMED, US FDA

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DOLPHIN 2000 DATEX COMPATIBLE OXIMETRY DISPOSABLE AND REUSABLE SENSORS AND EXTENSION CABLES

FDA 510(k)
FDA Class 2 ·Cardiovascular

Marina Medical

FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306801839·DeBakey Tissue Forceps, 2.0 mm Tip, 24 cm / 9.5 in

HARDYDISK, CEFOTAXIME 30MCG

FDA 510(k)
FDA Class 2 ·Microbiology

PATIENTNET MONITORING SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

5 CM HEAVY DUTY SHOR ATTACHMENT

FDA Adverse Event
Malfunction ·THE ANSPACH EFFORT, INC.·Product code HBC·April 10, 2013

ASR ACETABULAR CUPS 52

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·April 6, 2011

LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC.·Product code MKJ·June 11, 2008

STIMQ NEUROSTIMULATOR

FDA Adverse Event
Injury ·STIMWAVE TECHNOLOGIES INC.·Product code GZF·April 14, 2021

STIMQ NEUROSTIMULATOR

FDA Adverse Event
Injury ·STIMWAVE TECHNOLOGIES INC.·Product code GZF·April 8, 2021

FREEDOM NEUROSTIMULATOR

FDA Adverse Event
Injury ·STIMWAVE TECHNOLOGIES INC.·Product code GZB·March 10, 2021

FREEDOM NEUROSTIMULATOR

FDA Adverse Event
Injury ·STIMWAVE TECHNOLOGIES INC.·Product code GZB·April 9, 2021

STIMQ NEUROSTIMULATOR

FDA Adverse Event
Injury ·STIMWAVE TECHNOLOGIES INC.·Product code GZF·April 15, 2021

FREEDOM NEUROSTIMULATOR

FDA Adverse Event
Injury ·STIMWAVE TECHNOLOGIES INC.·Product code GZB·March 7, 2021

FREEDOM NEUROSTIMULATOR

FDA Adverse Event
Injury ·STIMWAVE TECHNOLOGIES INC.·Product code GZB·April 7, 2021

UNKNOWN BEARING

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JWH·March 10, 2017

FREEDOM NEUROSTIMULATOR

FDA Adverse Event
Injury ·STIMWAVE TECHNOLOGIES INC.·Product code GZB·March 24, 2021

The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022