10 results
·
27ms
·
Sources: EU EUDAMED, US FDA
MODIFICATION TO ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
SMARTLOCK
FDA UDI
Stryker Leibinger GmbH & Co. KG·37613154184492·Locking Screws, Cross-Pin
MODIFICATION TO: ECAT LSO PET/CT SCANNER
FDA 510(k)
FDA Class 2
·Radiology
RT-PLUS MODULAR CEMENTED KNEE COMPONENTS
FDA 510(k)
FDA Class 2
·Orthopedic
COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910)
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code GAM·March 27, 2013
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 1, 2011
TAPERED TOOL LEGACY, B-5
FDA Adverse Event
Malfunction
·MEDTRONIC POWERED SURGICAL SOLUTIONS·Product code HBB·April 2, 2008
PINNACLE SECTOR II CUP 60MM
FDA Adverse Event
Injury
·. DEPUY ORTHOPAEDIC INC, 1818910·Product code KWA·May 25, 2018
Calculator/ Data Processing Module for Clinical Use.
FDA Recall
Terminated
·Misys Healthcare Systems·Product code JQP·September 25, 2003
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