13 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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WALLSTENT RX BILIARY ENDOPROSTHESES, MODELS 6961-6972 INCLUSIVE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NVM5
FDA UDI
Nuvasive, Inc.·00887517070708·NVM5 Clips Sheath, Dynamic Stimulation
JAW INS. BULLET NOSE GRASPER 5MM 310MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code GEI·January 13, 2015
AESCULAP'S MODULAR ENDOSCOPIC INSTRUMENTS FOR GYNECOLOGY
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
BAYONET FORCEPS BIPOLAR IRRIGATING
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MARYLAND GSP.FORCEPS FEN.5/310MM HF CON.
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code GEI·February 19, 2014
3012752-001 QPACE 1/P 10/B 50/
FDA Adverse Event
Malfunction
·COVIDIEN·Product code MKJ·November 25, 2013
AED PLUS
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·February 22, 2013
R SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·March 2, 2011
LUMAX 340 DR-T
FDA Adverse Event
Malfunction
·BIOTRONIK GMBH AND CO.·Product code MRM·March 12, 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
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
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024