12 results
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35ms
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Sources: EU EUDAMED, US FDA
ABBOTT AXSYM B-TYPE NATRIURETIC PEPTIDE (BNP) MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033606·Baltic Denture System BDLoad BDLoad Sm6 PLSEbm...
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0330060·Rod Bender, 5.5 mm, 3 Position
TILITE YG AND TILITE YGS
FDA 510(k)
FDA Class 1
·Physical Medicine
ACS 180 HOMOCYSTEINE ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PORTASCAN
FDA Adverse Event
Malfunction
·MEDIWATCH UK LTD·Product code ITX·November 17, 2011
TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·April 3, 2013
HEARTSTRING III PROXIMAL SEAL SYSTEM, 3.8 MM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code DXC·February 11, 2011
ICL (IMPLANTABLE COLLAMER LENS)
FDA Adverse Event
Injury
·STAAR SURGICAL CO.·Product code HQL·April 24, 2008
McGhan Style 468-380cc Saline-Filled BIOCELL textured Breast Implants, Catalog Number:468-380
FDA Recall
Terminated
·Inamed Corp·Product code FWM·December 14, 2005
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