33 results · 22ms · Sources: EU EUDAMED, US FDA

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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