9 results
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35ms
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Sources: EU EUDAMED, US FDA
MBATH 1000 (60)
FDA 510(k)
FDA Class 2
·Physical Medicine
STERILE NITRILE SURGICAL GLOVES (POWDERED)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
BIOMESH P1 AND BIOMESH PLUG AND PATCH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CONTOUR THREAD OR CONTOUR THREADS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES (DBA ANGIOTECH)·Product code GAW·April 3, 2008
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 11, 2013
LUMAX 540 HF-T
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code MRM·March 15, 2011
POSTERIOR CHAMBER INTRAOCULAR LENS
FDA Adverse Event
Malfunction
·BAUSCH & LOMB·Product code HQL·May 22, 2008
cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014
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