15 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Navagio
FDA UDI
Kalitec Direct LLC·B07330K0134160·Trial, TLIF, 27L OB STR 7Deg, 16mm
INTUITIVE SURGICAL ENDOWRIST ENDOSCOPIC INSTRUMENT FAMILY
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Nu Alloy dp40 Caps. Jar X 500 - 1 Spill
FDA UDI
PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A·07701126650898·Nu Alloy dp40 Caps. Jar X 500 - 1 Spill
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033487969·
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0132160·Trial, TLIF, 27L OB CRV 7Deg, 16mm
MUSCLE IMAGING SYSTEM (MIS)
FDA 510(k)
FDA Class 2
·Radiology
HERACERAM 75
FDA 510(k)
FDA Class 2
·Dental
TRILOGY 200
FDA Adverse Event
Malfunction
·RESPIRONICS INC·Product code CBK·August 19, 2020
DYNASTY(R) A-CLASS(R) POLY LINER
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code JDL·March 20, 2013
INTEGRIS ALLURA 15-12 (MONO)
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code IZI·February 2, 2011
INSYNC MAXIMO
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·March 10, 2008
Torque Limiting Adapter: Torque Limiting Attachment, Non Sterile, Distributed by Zimmer. PRECIMED, Torque Limiting Adaptor, Non Sterile.. Customer Number/Model: 00-2360-080-00 T10232, T116245 T116245, TLA025-25 TLA025-25, 00-2360-080-05 T10233, MAC21003 T116430, TLA025-30 TLA025-30, MAC21001 T112972, MAC21001 T13621, TLA025-20 TLA025-20.
FDA Enforcement
Class II
·Terminated·Greatbatch Medical·June 8, 2016
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
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·June 29, 2022
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Enforcement
Class II
·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014