12 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Graftys Quickset
FDA 510(k)
FDA Class 2
·Orthopedic
Bernafon
FDA UDI
Sbo Hearing A/S·05714464033119·Alpha 9 FW 1.1.0
Orfit Industries
FDA UDI
Orfit Industries NV·05420028755419·SBRT Short Base Plate
OsteoMed
FDA UDI
OSTEOMED LLC·00845694022125·FPS 2.7mm Depth Gauge Assembly
LOCKING SCREW, FULLY THREADED 5X45 MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·October 30, 2009
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·October 7, 2025
Nitrile Exam Gloves, Powder Free,Blue (Tested for Use with Chemotherapy)
FDA 510(k)
FDA Class 1
·General Hospital
INION TRINION BIODEGRADABLE MENISCUS SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·November 4, 2014
MINICAP TRANSFER SET
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·September 1, 2011
PARIETEX UGYTEX PP POSTERIOR KIT X1
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code OTO·July 12, 2013
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022