97 results · 26ms · Sources: EU EUDAMED, US FDA

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K2M COCR ROD

FDA 510(k)
FDA Class 2 ·Orthopedic

SchureMed

FDA UDI
SCHUERCH CORPORATION·00810014607535·SKYTRON 6700, 6701 3" SOFTCARE

MAMMOGRAPH

FDA 510(k)
FDA Class 2 ·Radiology

CITRASATE DIALYSATE ACID CONCENTRATE LIQUID, MODELS CS-1XXX-XX, CS-XXX-XX, CS-3XXX-XX

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

QUADRA BROACH SIZE 0

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL, SA·Product code JDI·September 7, 2012

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

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·May 6, 2011

LIFEVEST WCD 4000 SYSTEM

FDA Adverse Event
Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·April 12, 2013

INSULIN PUMP INFUSION SET

FDA Adverse Event
Injury ·MEDTRONIC·Product code FPA·September 7, 2014

CARDIAC SURGERY PACK BO-TOP 36500

FDA Adverse Event
Malfunction ·DATASCOPE FAIRFIELD·Product code DWE·March 28, 2017

VERSAFITCUP CC TRIO 01.26.45.1150 ACETABULAR SHELL CC TRIO NO-HOLE Ø 50

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·December 7, 2021

CUSTOM TUBING PACK

FDA Adverse Event
Malfunction ·DATASCOPE FAIRFIELD·Product code DWE·February 1, 2017

VERSAFITCUP CC TRIO ACETABULAR SHELL 58

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL, SA·Product code LZO·April 8, 2013

COCR BALL HEADS 32 SIZE M.

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·July 29, 2011

CUSTOM TUBING PACKS

FDA Adverse Event
Malfunction ·DATASCOPE FAIRFIELD·Product code DWE·February 1, 2017

BO-TOP 36500 QUADROX OXYGENATOR

FDA Adverse Event
Malfunction ·DATASCOPE FAIRFIELD·Product code DWE·November 14, 2017

QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 4

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·December 19, 2017

QUADRA H FEMORAL STEMS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·May 15, 2026

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