15 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SYNTHES 5.0/7.3 MM CANNULATED LOCKING SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·January 5, 2016
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·November 13, 2015
MICROVASIVE ZERO TIP AIRWAY RETRIEVAL BASKET, MODELS M00513200 AND M00513210
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
COULTER HMX ANALYZER, MODEL 6605523, COULTER HMX WITH AUTOLOADER, MODEL 6605526
FDA 510(k)
FDA Class 2
·Hematology
ENERGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·April 8, 2013
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·March 22, 2011
CVC KIT: 3-LUMEN 7 FR X 20 CM
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code DQO·May 9, 2008
COULTER ISOTON III DILUENT
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GIF·May 1, 2014
COULTER ISOTON III DILUENT
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GIF·April 28, 2014
COULTER ISOTON III DILUENT
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GIF·March 27, 2014
BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code OYE·May 8, 2025
BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code OYE·March 28, 2025
Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD Inc.·December 18, 2019
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018