13 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STRYKER T6 HOODS AND TOGAS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Trulife
FDA UDI
Trulife Limited·00645517612690·ActiveFlow External Breast Form Size 05
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0330050·Vise Grip, Large, 5.5mm
Easydrip ReadyGard Safety Pen Needles 30G×5mm
FDA UDI
Sandstone Medical (Suzhou) Inc.·16972857293588·
TISSUELINK BIPOLAR FORCEPS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ACT 11 MP VENTRICULAR CATHETER
FDA 510(k)
FDA Class 2
·Neurology
PROLIFT PELVIC FLOOR REPAIR
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTP·April 17, 2013
COBAS 6000 C501 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CEM·June 18, 2008
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 11, 2011
SYRINGE 3ML LL 200 S/C
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·July 21, 2021
Careflow 7Fr x 20cm 3-lumen Central Venous Catheter Tray
FDA Recall
Terminated
·Becton Dickinson Infusion Therapy·Product code FOZ·January 10, 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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015