8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine System
FDA 510(k)
FDA Class 2
·Orthopedic
BIOACTIF OSTEOTRANS INTERFENCE SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
FASTPACK TSH IMMUNOASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ELEFANT SUCTION-IRRIGATION DEVICE
FDA Adverse Event
Injury
·COLOPLAST A/S·Product code FQH·January 18, 2024
RESTORE SENSOR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 21, 2013
PRECISE PAIN RELIEVING HEAT PATCH
FDA Adverse Event
Injury
·KIRIBAI KOBAYASHI PHARMACEUTICAL CO., LTD.·Product code IMD·July 21, 2011
RESTORE ADVANCED RECHARGEABLE
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·September 24, 2008
XP-XP Tibial Tray - Interlok 67 mm Item # 195753
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019