16 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PHOENIX INFUSION CATHETER
FDA 510(k)
FDA Class 2
·Neurology
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091033017·Baltic Denture System BDLoad ↓ Mw6 PLSEum2DFm C...
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0330150·Coronal Bender, Left
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0330160·Coronal Bender, Right
InTess L
FDA UDI
Kalitec Direct LLC·B07312K0310170·T-Handle, Fixed, 1/4" Square
BD LUER-LOK¿ TIP SYRINGE WITH THE BD PRECISIONGLIDE¿ NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·May 6, 2022
GRAMSORB SYNTHETIC ABSORBABLE SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MEDIGROUP KEY TUBE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NA
FDA UDI
Zimmer, Inc.·00889024114173·
PIPELINE EMBOLIZATION DEVICE
FDA Adverse Event
Injury
·EV3 NEUROVASCULAR·Product code OUT·April 3, 2013
SENSOR ENLITE MMT-7008A
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OZO·August 25, 2014
BD DTX PLUS
FDA Adverse Event
Malfunction
·BECTON DICKINSON CRITICAL CARE SYSTEMS PTE LTD.·Product code DRS·April 22, 2008
NAIL, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code JDS·July 25, 2016
NAIL, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code JDS·July 25, 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
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