12 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ARTIC
FDA 510(k)
FDA Class 2
·Dental
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033628·Baltic Denture System BDLoad BDLoad Lm6 PLSEbi...
MAGNETOM RHAPSODY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
SPECTRANETICS QUICK-CROSS SUPPORT CATHETER
FDA Adverse Event
Injury
·THE SPECTRANETICS CORPORATION·Product code DQY·March 6, 2019
MRS 17MM X 127MM FEMORAL STEM
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS-MAHWAH·Product code KRO·April 3, 2013
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·March 30, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 25, 2014
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