9 results · 19ms · Sources: EU EUDAMED, US FDA

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IVENT 302VC DUAL CONTROLLER

FDA 510(k)
FDA Class 2 ·General Hospital

STOP FOR CONICAL DRILL

FDA UDI
SWEDEN & MARTINA SPA·D7701609763·STOP FOR CONICAL DRILL D.3.80-D.4.25 - H.21MM

CONICAL TIPPED CENTRIFUGE TUBE 15M

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

MSD SILO SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·May 31, 2014

LIFEVEST WCD 3000 SYSTEM

FDA Adverse Event
Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·November 12, 2012

DIAMOND-FLEX TRIANGULAR RETRACTOR

FDA Adverse Event
Malfunction ·CAREFUSION·Product code GCJ·August 26, 2010

Product Description/Item: ChemoLock Vial Spike, 20mm/011-CL-80S; ChemoLock Bag Spike/CL-10; ChemoLock w/Mini Bag Spike/CL-17; 8 IN (20cm) APPX 1.0ml, EXT SET, MicroClave Clear, ChemoLock PORT, YCONN/CL3950; 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros, Purple Cap, Hanger/CL3951; 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock Port, Clamp, Graduated Adapter/CL3967; 6 IN(15cm)APPX 0.82ml,EXT SET,MicroClave Clear,ChemoLock PORT,YCONN, ROTATING LUER/CL4118; ChemoLock Kit w/ 5" (13 cm) Bag Spike Adapter w/ChemoLock w/Red Cap, Vented Cap, ChemoLock Port Bag Spike/CL4158; ChemosafeLock Bag Spike/KL-BS001U3; ChemosafeLock Vial Adapter/KL-VA201U3; ChemosafeLock Vial Adapter/KL-VA202U3; ChemosafeLock Vial Adapter/KL-VA321U3; ChemosafeLock Vial Adapter/KL-VA322U3; ChemoLock Vented Vial Spike/011-CL-51; Transfer Set, PUR Yellow w/ChemoLock Port, Spiros/011-CL4155; Puerto ChemoLock/034-CL2100; ChemoLock, Punzon Univ. Vial c/ Filtro, fijacion/034-CL-70; ChemoLock, Punzon Vial Tritan c/ Filtro, 13mm/034-CL-72

FDA Enforcement
Class II ·Ongoing·ICU Medical, Inc.·September 14, 2022

PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·October 25, 2017