14 results
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19ms
·
Sources: EU EUDAMED, US FDA
DAC-CEL T3 UPTAKE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526743489·LEVAMED ANKLE SUPPORT SILVER II
Laparostat
FDA UDI
CIVCO MEDICAL INSTRUMENTS CO., INC.·00841436111133·Laparostat
neoWave LS
FDA UDI
XENIX MEDICAL LLC·00818345023956·PADDLE SPREADER, 12MM
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0102120·Shaver, Open 12mm
iNSitu™ Hip System
FDA UDI
NEXTSTEP ARTHROPEDIX, LLC·00816127020438·Neck Trial, Size 12, Lateral
OFFSET TIBIAL TRAY
FDA 510(k)
FDA Class 2
·Orthopedic
INRATIO2 PI/NR MONITORING SYSTEM; INRATIO PT/INR TEST STRIP
FDA 510(k)
FDA Class 2
·Hematology
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILLROM DE MEXICO S DE RL DE CV·Product code FPO·February 5, 2014
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE, INC., USA·Product code LFR·October 9, 2007
ADVANTAGE BALLOON CATHETER INFLATION DEVICE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - CORK·Product code MAV·October 31, 2012
INRATIO PT/INR TEST STRIPS
FDA Adverse Event
Injury
·ALERE SAN DIEGO, INC·Product code GJS·July 14, 2017
Product Name: Evolution Upgrade 1.5T; Model Numbers: (1) 782116, (2) 782148;
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·May 28, 2025
EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic use.
FDA Enforcement
Class II
·Terminated·Dako North America Inc.·November 11, 2015