19 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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KATALYST RADIAL HEAD IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
Dornier MedTech
FDA UDI
Dornier MedTech GmbH·04049957003135·Gemini Lithotripter, 50 KW
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032806·Baltic Denture System BDLoad Mm7 PLSEbim6DFm A3...
8FR OPTICATH CATHETER
FDA Adverse Event
Malfunction
·ICU MEDICAL, INC.·Product code DYG·March 13, 2013
K-DEFIB/PACE, MODEL KDP-60A
FDA 510(k)
FDA Class 3
·Cardiovascular
CYNOSURE PHOTOGENICA VL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
General Instrument
FDA UDI
ALPHATEC SPINE, INC.·00840180506059·Curette, Cup, Right Angled, Straight, Serrated,...
AMINGO
FDA Adverse Event
Malfunction
·DATEX-OHMEDA, INC.·Product code BSZ·December 9, 2016
AMINGO
FDA Adverse Event
Malfunction
·DATEX-OHMEDA, INC.·Product code BSZ·December 30, 2016
AMINGO
FDA Adverse Event
Malfunction
·DATEX-OHMEDA, INC.·Product code BSZ·December 29, 2016
AMINGO
FDA Adverse Event
Malfunction
·DATEX-OHMEDA, INC.·Product code BSZ·January 4, 2017
RESTORE SENSOR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 3, 2013
COLLEAGUE COLOR PUMP CE FRENCHVERSION SINGLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·March 29, 2011
COMPOSIX MESH E/X
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·April 21, 2008
PS TIBIAL INSERTS SZ 6, 11MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·September 29, 2022
Detachable T-handle (Orthopedic Manual Surgical Instrumentation) Catalog Number 803-00-047 Revision G
FDA Recall
Terminated
·Product code LXH·October 21, 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
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018