16 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES, MODEL PPH01
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR20309251·BioStarter wires Straight-Arch-F. mand. .010"
DRACO
FDA UDI
HNM TOTAL RECON LLC·00841742121925·DRACO MetaFuse Midfoot/Lisfranc Plate, Ti - (L)...
PROCEED MULTI-LAYER LAMINATE MESH
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·June 16, 2006
PROWLER INFUSION CATHETERS WITH PRE-SHAPED TIPS
FDA 510(k)
FDA Class 2
·Cardiovascular
SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E
FDA 510(k)
FDA Class 2
·Anesthesiology
PROCEED MULTI-LAYER LAMINATE MESH
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·June 26, 2006
PROCEED MULTI-LAYER LAMINATE MESH
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·June 26, 2006
PROCEED MULTI-LAYER LAMINATE MESH
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·June 27, 2006
VC10 PUMP, 115V
FDA Adverse Event
Malfunction
·GYRUS ACMI, INC.·Product code HHK·January 2, 2025
ONCOLOGY KIT W/SPINNING SPIROS, C-CLIP, RED CAP
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FPA·April 26, 2021
ENDOTRACHEAL TUBE - AIRWAY MANAGEMENT
FDA Adverse Event
Malfunction
·UNOMEDICAL SDN BHD·Product code BTR·March 28, 2013
SOLETRA
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·March 4, 2011
PASCAL PHOTOCOAGULATOR
FDA Adverse Event
Malfunction
·OPTIMEDICA CORPORATION·Product code GEX·April 17, 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
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