12 results
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19ms
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Sources: EU EUDAMED, US FDA
FACTOR II (PROTHROMBIN) G20210A KIT
FDA 510(k)
FDA Class 2
·Hematology
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033612·Baltic Denture System BDLoad BDLoad Mm6 PLSEbi...
Humelock Reversed Shoulder
FDA UDI
FX SOLUTIONS·03701037304662·TRIAL HUMELOCK REVERSED STEM Ø36/12
MICROSPEED EC MOTORSYSTEM GD650/GD653
FDA 510(k)
FDA Class 2
·Neurology
INCARE PELVIC FLOOR THERAPY SYSTEM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MRS CURVED FEM STEM 17 X 127MM
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS-MAHWAH·Product code KRO·April 3, 2013
FUSION NAVIGATION SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·February 11, 2011
SYNCHROMED EL
FDA Adverse Event
Injury
·RICE CREEK MFG·Product code LKK·April 24, 2008
ROD, FIXATION, INTRAMEDULLARY
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HSB·January 22, 2017
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
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
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024