11 results
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20ms
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Sources: EU EUDAMED, US FDA
VACORA 14G BIOPSY PROBES, MODELS VB14116, VB14138
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DRILL 1.5X105MM 22MM STP J-NT
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HBE·June 16, 2021
DRILL 1.5X105MM 22MM STP J-NT
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HBE·April 28, 2021
DRILL 1.5X105MM 22MM STP J-NT
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HBE·June 4, 2021
COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200; COMFORTMATE DISPORSABLE DISPOSABLE WARMING SET, MODEL #FWS-200
FDA 510(k)
FDA Class 2
·General Hospital
CONDUCTIVE GEL FOR ULTRASOUND
FDA 510(k)
FDA Class 2
·Neurology
ENSEAL TRIO
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code GEI·April 8, 2013
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·June 18, 2008
PRECISE PRO RX CAROTID STENT SYSTEM
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIM·April 19, 2011
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