11 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LUMEND FRONTRUNNER CTO CATHETER AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Cardiovascular
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033535·Baltic Denture System BDLoad BDLoad ↓ Mm6 PLSEu...
EVTOOL MODEL # V. 1.0
FDA 510(k)
FDA Class 2
·Radiology
STYLET KIT, MODELS 6254,6282,6293
FDA 510(k)
FDA Class 2
·Cardiovascular
EQUINOXE PRIMARY SHOULDER COMPONENTS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·February 18, 2026
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·April 3, 2013
OCTRODE PERCUTANEOUS LEAD
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 24, 2011
STERLING MONORAIL
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQY·April 24, 2008
HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Number: 72203697
FDA Enforcement
Class II
·Ongoing·Smith & Nephew, Inc.·October 28, 2020
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