11 results
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26ms
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Sources: EU EUDAMED, US FDA
MODIFICATION HYBRID CAPTURE II CT-ID DNA TEST, MODEL 03M91-01
FDA 510(k)
FDA Class 1
·Microbiology
Endo Carry-on Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964152573·Endo Carry-on Procedure Kit contains Basin, VIA...
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526743595·LEVAMED ANKLE SUPPORT SAND II
ULTRACISION SURG, DEV, BLADES 5MM OPEN
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code LFL·June 16, 2006
DATEX-OHMEDA EEG MODULE, M-EEG AND DATEX-OHMEDA EEG HEADBOX, N-EEG AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Neurology
WHITE KNIGHT MASKS (21 MODELS, VARIOUS COLORS WITH AND WITHOUT FACE SHIELDS)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MITEK FEMORAL AIMER 5MM OFFSET
FDA Adverse Event
Malfunction
·DEPUY MITEK·Product code LXH·March 19, 2013
NC QUANTUM APEX PTCA DILATATION CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·March 8, 2011
TENDRIL DX
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 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
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018