9 results
·
22ms
·
Sources: EU EUDAMED, US FDA
COGAN CORP KITS OF DENTAL HAND INSTRUMENTS
FDA 510(k)
FDA Class 1
·Dental
ROMFLEX REHABILITATION EQUIPMENT
FDA 510(k)
FDA Class 1
·Physical Medicine
EQUIPMENT/MATERIAL DECONTAMINATING KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
VASOVIEW HEMOPRO EVH SYSTEM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·November 2, 2010
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 7, 2014
HEARTSINE SAMARITAN 300P AND PAD PAK
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·December 19, 2012
ASTROGLIDE
FDA Adverse Event
Malfunction
·COMBE INC·Product code KMJ·January 16, 2024
3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod¿, Part Number (Item #) AG8049-NS, Lot # 2528655. K914299. Waste system.
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·October 17, 2012
3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod, Part Number (Item #) AG8049-NS, Lot # 2528655. K914299. Waste system.
FDA Recall
Terminated
·ICU Medical, Inc.·Product code DQO·September 28, 2012