9 results
·
19ms
·
Sources: EU EUDAMED, US FDA
CELL-DYN CALIBRATOR
FDA 510(k)
FDA Class 2
·Hematology
TITAN PLUG SCREW 8MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA GMBH·Product code HSB·February 21, 2002
FRSENIUS PD IQCARD CYCLER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
1-M GRADUATED COMPRESSION ANTI-EMBOLISM STOCKING, MODEL SS-811, SS-508, SS-613
FDA 510(k)
FDA Class 2
·General Hospital
ADJ PIN COLLET 2.0-3.2MM
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·November 12, 2010
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 9, 2013
TX1 TISUE REMOVAL SYSTEM - MICROTIP
FDA Adverse Event
Malfunction
·TENEX HEALTH·Product code LFL·February 24, 2014
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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