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