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