11 results
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35ms
·
Sources: EU EUDAMED, US FDA
KETONE TEST A SANWA STANDARD
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Brigade
FDA UDI
Nuvasive, Inc.·00887517961792·Brigade Lateral Trial, 9x34x28mm 8°
T2 - NAIL HOLDING SCREW, TIBIA 10 MM
FDA Adverse Event
Malfunction
·STRYKER GMBH·Product code LXH·May 21, 2025
T2 - NAIL HOLDING SCREW, TIBIA 10 MM
FDA Adverse Event
Malfunction
·STRYKER GMBH·Product code LXH·June 23, 2025
STERILE SALINE SOLUTION
FDA 510(k)
FDA Class 2
·Ophthalmic
ORION PLATINUM
FDA 510(k)
FDA Class 2
·Neurology
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·June 30, 2014
KUGEL PATCH
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·November 10, 2010
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 14, 2012
T2 - NAIL HANDLE
FDA Adverse Event
Malfunction
·STRYKER GMBH·Product code LXH·May 21, 2025
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012