15 results
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26ms
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Sources: EU EUDAMED, US FDA
CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT
FDA 510(k)
FDA Class 2
·Immunology
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040012949·Zirlux 16+ White 95X30
CERASMART®
FDA UDI
Gc America Inc.·D0470119581·CERASMART® Glidewell 14 A3.5 LT 5p Block
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496011958·NAOMI 100, SIZE S, BLU SCURO, GRADUATED COMPRES...
INSET II
FDA Adverse Event
Injury
·UNOMEDICAL A/S·Product code FPA·September 17, 2025
FISTULOK FISTULA NEEDLE PROTECTION
FDA 510(k)
FDA Class 2
·General Hospital
KEYSTONE MEDICAL SCHON XL SOFT-LINE DOUBLE LUMENT CATHETER. KEYSTONE MEDICAL 12 F DUO-FLOW AND 14F DUO-FLOW 400 XL CATH
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SYNERGY
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 18, 2012
FLEXOR RADIAL ACCESS SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·November 16, 2015
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 20, 2013
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·February 10, 2011
NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-POSTERIOR STABILIZED PROLONG HIGHLY CR
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code JWH·March 11, 2008
BD Interlink threaded lock cannula This is a locking blunt plastic cannula specifically designed for IV connection to an Interlink¿ injection site. It is screwed down over the Interlink¿ injection site and a blunt plastic cannula inside the housing enters the Interlink¿ injection site to provide a pathway for IV fluid administration.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·January 22, 2014
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
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Enforcement
Class II
·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014