20 results
·
32ms
·
Sources: EU EUDAMED, US FDA
STRYKER ANTIMIC CATHETER
FDA 510(k)
FDA Class 2
·Anesthesiology
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00840180502969·Distractor Tip, Lamina, No Offset, Left
BUECHEL-PAPPAS (B-P) FIXED BEARING NEW JERSEY (NJ) TOTAL KNEE, MODEL 1
FDA 510(k)
FDA Class 2
·Orthopedic
NEUROTOLOGY DRAPE, MODEL TBD
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 27, 2021
NAIL HANDLE T2 TIBIA
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code LXH·March 3, 2016
TROCAR, LONG T2 FEMUR
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code LXH·March 3, 2016
WAVEWRITER ALPHA?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·May 12, 2025
OT SELECT SIMPLE METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 23, 2013
KAPPA 700 DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code DXY·July 10, 2008
DA VINCI SI SURGICAL SYSTEM
FDA Adverse Event
Other
·INTUITIVE SURGICAL,INC.·Product code NAY·April 29, 2011
1920898-2018-00830
FDA Adverse Event
Malfunction
·November 5, 2018
BD SOLOMED¿ SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code FMF·April 17, 2018
9.0MM MEDULLARY REAMER HEAD
FDA Adverse Event
Injury
·SYNTHES SELZACH·Product code HTO·July 15, 2015
5.0MM FLEXIBLE SHAFT
FDA Adverse Event
Injury
·SYNTHES BETTLACH·Product code HTO·July 15, 2015
TIBIAL NAIL, STANDARD T2 TIBIA Ø9X360 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code HSB·March 3, 2016
NAIL HOLDING SCREW, TIBIA T2 TIBIA 10 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code LXH·March 3, 2016
KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE
FDA 510(k)
FDA Class 2
·Neurology
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
Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018