20 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PTS PANELS LIPID PANEL TEST STRIPS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Safco Ellipses Swivel Couplers
FDA UDI
SAFCO DENTAL SUPPLY CO.·00810063750664·Safco Ellipses swivel couplers, 6 pin, LED
OneTouch Verio
FDA UDI
LifeScan Europe GmbH·00353885009751·OneTouch Verio Blood Glucose Test Strips. In vi...
CURON CONTROL MODULE ELECTROSURGICAL GENERATOR AND ACCESSORIES, MODEL S500-ST
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
ST. JOSEPH HSP BALTIMORE MD1
FDA Adverse Event
Other
·SORIN GROUP USA, INC.·Product code DWF·October 1, 2010
ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)
FDA Adverse Event
Malfunction
·ANGIOSCORE, INC.·Product code LIT·March 20, 2013
TIBIAL RESECTION BLOCK 7 DEG
FDA Adverse Event
Malfunction
·DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS·Product code LXH·February 24, 2011
BRAVO
FDA Adverse Event
Malfunction
·ARIZONA DEVICE MANUFACTURING·Product code FFT·March 28, 2008
BD ULTRA-FINE¿ PEN NEEDLE MINI
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·March 26, 2020
CSC14 BLOOD CARDIOPLEGIA SYSTEM
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTR·December 23, 2020
PEN NDL 31GA 5MM 100 BX 1200 LA
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·February 6, 2020
CHILDRENS MERCY KS CITY MO1
FDA Adverse Event
Other
·SORIN GROUP USA, INC.·Product code DTZ·August 10, 2010
SMART, PERFUSION PACKS, CONNECTORS, TUBING
FDA Adverse Event
Malfunction
·LIVANOVA USA·Product code DWE·August 1, 2023
CSC14 CARDIOLOGIA HEAT EXCHANGER
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTR·April 20, 2023
CSC14 BLOOD CARDIOPLEGIA SYSTEM
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTR·March 10, 2016
CSC14 BLOOD CARDIOPLEGIA SYSTEM
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTR·November 20, 2015
CSC14 BLOOD CARDIOPLEGIA SYSTEM
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTR·October 18, 2019
CHILDRENS MERCY KS CITY MO1
FDA Adverse Event
Other
·SORIN GROUP USA, INC.·Product code DTZ·August 10, 2010
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