11 results
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19ms
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Sources: EU EUDAMED, US FDA
ULTRAFLEX PRECISION COLONIC STENT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120307691·Diamond, cylinder round, medium grit
ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES, MODEL 87
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
KSEA MANHES PNEUMOTROCAR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
1.5MM RESORB ORBITAL FLOOR PL 24MMX24MM W/BENDING TEMP-STER
FDA Adverse Event
Injury
·SYNTHES USA·Product code JEY·November 2, 2012
BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE HOLDER WITH PRE-ATTACHED ADAPTER
FDA Adverse Event
Malfunction
·BD CARIBE LTD.·Product code JKA·October 24, 2023
LARGE SUTURE CUT NEEDLEDRIVERINSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·April 2, 2013
DURATA STS OPTIM ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·August 22, 2014
OT VERIO IQ METER
FDA Adverse Event
LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 26, 2015
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
Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: CD3249-40 and CD3249-40Q; Unify Assura, Model Numbers: CD3257-40, CD3257-40Q, CD3357-40C, CD3357-40Q; Quadra Assura, Model Numbers: CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q; Quadra Assura MP, Model Numbers: CD3269-40, CD3269-40Q, CD3369-40C, CD3369-40Q Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing
FDA Enforcement
Class I
·Terminated·St Jude Medical Inc.·October 18, 2017