17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ADVANCE DOUBLE HIGH INSERT
FDA 510(k)
FDA Class 2
·Orthopedic
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033890·Baltic Denture System BDLoad BDLoad Lw6 PLSEbi...
ALPHATEC
FDA Adverse Event
ALPHATEC MFG INC. AKA NEXMED INC·Product code HWC·February 26, 2004
VHF ULTRASONIC ARC-SCAN SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
SURGICAL DYNAMICS MENISCAL STAPLE
FDA 510(k)
FDA Class 2
·Orthopedic
EQUINOXE HUMERAL STEM PRIMARY PRESS FIT 10MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWS·December 29, 2023
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·April 3, 2013
IAB: 7.5 FR - 40 CC
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code DSP·February 11, 2011
ONE TOUCH ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·April 25, 2008
OPTILENE 6/0 (0,7) 75CM 2XDRC10 CV RCP
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAW·December 6, 2019
OPTILENE 6/0 (0,7) 45CM DS16 (M) RCP
FDA Adverse Event
Malfunction
·B/ BRAUN SURGICAL SA·Product code GAW·July 22, 2019
OPTILENE 6/0 (0,7) 45CM DS16 (M) RCP
FDA Adverse Event
Malfunction
·B/ BRAUN SURGICAL SA·Product code GAW·July 22, 2019
OPTILENE 6/0 (0,7) 45CM DS16 (M) RCP
FDA Adverse Event
Malfunction
·B/ BRAUN SURGICAL SA·Product code GAW·July 22, 2019
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018
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
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013