11 results
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18ms
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Sources: EU EUDAMED, US FDA
CORING NEEDLE (TREPHINE, ORTHOPEDIC)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
EDENTA
FDA UDI
EDENTA ETABLISSEMENT·E312K90044710001·Dowel Pin 17 mm
TROCHANTERIC NAIL KIT, TI GAMMA3 11X180MM X 125
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·October 1, 2012
MODIFICATION TO RAPID DRUG SCREEN 9-PANEL
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER), DT SERIES
FDA 510(k)
FDA Class 2
·General Hospital
SUPRACONDYLAR NAIL T2 SCN 10 X 200 MM
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS ¿ KIEL·Product code HSB·July 17, 2012
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 6, 2014
POWER PRO AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER CORP., MEDICAL DIV.·Product code INK·November 12, 2010
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·January 8, 2013
UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·August 13, 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