12 results
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37ms
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Sources: EU EUDAMED, US FDA
BAYER SPECIFIC PROTEIN REFERENCE SERUM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033791·Baltic Denture System BDLoad BDLoad ↓ Sw6 PLSEu...
BD AUTOSHIELD¿ DUO PEN NEEDLE 30GX5MM
FDA Adverse Event
Injury
·BECTON DICKINSON AND CO.·Product code FMI·August 25, 2016
NUSOFT SPHERICAL, TORIC, ASPHERIC AND BIFOCAL (OCUFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR
FDA 510(k)
FDA Class 2
·Ophthalmic
CAVEX TEMPORARY CEMENT
FDA 510(k)
FDA Class 2
·Dental
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 3, 2013
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·March 23, 2011
GENESIS II
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC., ORTHOPAEDIC DIV.·Product code HSA·April 25, 2008
HEARTMATE MOBILE POWER UNIT, UK
FDA Adverse Event
Malfunction
·THORATEC CORPORATION·Product code DSQ·May 21, 2021
Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 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