33 results
·
22ms
·
Sources: EU EUDAMED, US FDA
HYPERVISOR VI CENTRAL MONITORING SYSTEM (INCLUDING TMS)
FDA 510(k)
FDA Class 2
·Cardiovascular
DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS) network transfers information between DOM Central Station and other network devices. It also allows information transfer between several CMS. Network connections consist of hardwired network cables and or WLAN connections. The DPM Central Station is used for remote monitor management, storing, printing, reviewing, or processing of information from net worked devices, and it is operated by medical personnel in hospitals or medical institutions.
FDA Enforcement
Class II
·Terminated·Mindray DS USA, Inc. d.b.a. Mindray North America·January 9, 2013
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014604961·BERCHTOLD B810, B710 5.25" DELUXE GEL
E3 MICROPROB SERIES OF LASERS AND ACCESSORIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ENDOSCOPIC TUBE SHAFT INSTRUMENTS FOR MONOPLAR COAGULATION
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 29, 2026
OPEN HEART PACK WITHOUT PLEGIOX BEQ-TOP 40010
FDA Adverse Event
Malfunction
·DATASCOPE FAIRFIELD·Product code DWE·May 5, 2017
OPEN HEART PACK WITHOUT PLEGIOX BEQ-TOP 40010
FDA Adverse Event
Malfunction
·DATASCOPE FAIRFIELD·Product code DWE·May 5, 2017
CARDIAC SURGERY PACK BO-TOP 36500
FDA Adverse Event
Malfunction
·DATASCOPE FAIRFIELD·Product code DWE·March 28, 2017
CUSTOM TUBING PACK
FDA Adverse Event
Malfunction
·DATASCOPE FAIRFIELD·Product code DWE·February 1, 2017
CUSTOM TUBING PACKS
FDA Adverse Event
Malfunction
·DATASCOPE FAIRFIELD·Product code DWE·February 1, 2017
RIATA ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·April 26, 2013
NATURAL-HIP SYSTEM FULLY-TOOTHED BROACH
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code HAW·April 7, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·July 22, 2008
BO-TOP 36500 QUADROX OXYGENATOR
FDA Adverse Event
Malfunction
·DATASCOPE FAIRFIELD·Product code DWE·November 14, 2017
CUSTOM TUBING PACK
FDA Adverse Event
Malfunction
·DATASCOPE FAIRFIELD·Product code DWE·February 1, 2017
CUSTOM SURGERY PACK BO-TOP 36500/ QUADROX
FDA Adverse Event
Malfunction
·DATASCOPE FAIRFIELD·Product code DWE·September 28, 2017
BEQ-TOP 5210 ECC PACK
FDA Adverse Event
Malfunction
·DATASCOPE FAIRFIELD·Product code DWE·November 9, 2017
CUSTOM PACK BO-T 25102
FDA Adverse Event
Malfunction
·DATASCOPE FAIRFIELD·Product code DWE·March 31, 2017
CUSTOM TUBING PACK BO TOP 25102
FDA Adverse Event
Malfunction
·DATASCOPE FAIRFIELD·Product code DWE·March 31, 2017