13 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE
FDA 510(k)
FDA Class 2
·Hematology
APC™ PLUS Unitek™ Mini Uni-Twin
FDA UDI
3M UNITEK CORPORATION·00652221093141·Mini Uni-Twin(TM) Bracket APC(TM) PLUS Standard...
APC™ II Unitek™ Mini Uni-Twin
FDA UDI
3M UNITEK CORPORATION·00652221062123·Mini Uni-Twin(TM) Bracket APC(TM) II Standard E...
3M™ Unitek™ Uni-Twin™
FDA UDI
3M UNITEK CORPORATION·00652221016218·Mini Uni-Twin(TM) Bracket Standard Edgewise U4,...
ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST
FDA 510(k)
FDA Class 2
·Immunology
INTUITIVE SURGICAL DA VINCI ENDOSCOPIC CONTROL SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BIOMEDICS 1 DAY (52%) STRIP (OCUFILCON B)
FDA Adverse Event
Injury
·COOPERVISION CARRIBEAN CORPORATION·Product code MVN·August 29, 2019
DA VINCI ROBOTICS SYSTEM
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC.·Product code NAY·October 21, 2003
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 26, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·February 16, 2011
PHILOS II DR
FDA Adverse Event
Injury
·BIOTRONIK GMBH AND CO.·Product code DXY·March 28, 2008
BAXJECT II HI-FLOW NEEDLESS TRANSFER DEVICE
FDA Adverse Event
Malfunction
·TAKEDA PHARMACEUTICALS U.S.A., INC.·Product code LHI·May 4, 2026
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