11 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM
FDA 510(k)
FDA Class 2
·Dental
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00403691·
Myo/Wire II
FDA UDI
A & E MEDICAL CORPORATION·10841291101772·SS Suture, 6 per sleeve
CLARIS PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
VACUFLOW+ BLOOD COLLECTION SET, MODEL 52221/3/5; VACUFLOW+ WITH HOLDER BLOOD COLLECTION SET, MODEL 82021/3/5 WITH HOLDER
FDA 510(k)
FDA Class 2
·General Hospital
RINGLOC RIMCUP SHELL
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code LPH·August 31, 2017
MIH MOD CUP INSERTER
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LXH·August 17, 2017
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·March 12, 2013
PMO COMBINED PROBE CONTAINING BOTH OXYGEN AND TE
FDA Adverse Event
Malfunction
·GMS-GESELLSCHAFT FUR MEDIZINISHE·Product code GWM·February 15, 2011
OUTLOOK 200 WITH PIGGYBACK REMINDER
FDA Adverse Event
Malfunction
·B. BRAUN MEDICAL, INC.·Product code FRN·May 6, 2008
Check-Flo Introducer Hausdorf-Lock Atrial, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices
FDA Enforcement
Class II
·Terminated·Cook Inc.·March 8, 2017