12 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GM3 SERIES HV TENS, MODEL GM3X3HV (WHERE X IS PARAMETER OF DIFFERENT HOUSING)
FDA 510(k)
FDA Class 2
·Neurology
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032994·Baltic Denture System BDLoad Sw7 PLSEbm6DFs C3 ...
ORIA SPINAL CLIP SYSTEM, TYPES BD AND BJ
FDA 510(k)
FDA Class 2
·Orthopedic
WIZAIR DVT
FDA 510(k)
FDA Class 2
·Cardiovascular
OASYS BLOCKER
FDA Adverse Event
Injury
·STRYKER SPINE-FRANCE·Product code KWP·November 30, 2015
STERRAD® CYCLESURE® 24 BIOLOGICAL INDICATOR
FDA Adverse Event
Malfunction
·ADVANCED STERILIZATION PRODUCTS·Product code FRC·April 3, 2013
UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JGS·March 29, 2011
BD 10 ML SYRINGE LUER LOK TIP
FDA Adverse Event
Malfunction
·BD·Product code FMF·April 21, 2008
CombiSet True Flow Series, Hemodialysis Blood Tubing with Priming Set and Transducer Protectors, with Access Flow Reversing Connector (Twister) Product Code: 03-2994-6 24 sets / case CombiSet Bloodlines Including split-septum injection site, viral-retentive transducer protectors, & priming set & Twister device
FDA Recall
Terminated
·Fresenius Medical Care North America·Product code KOC·November 25, 2008
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
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024