13 results · 22ms · Sources: EU EUDAMED, US FDA

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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