30 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105
FDA 510(k)
FDA Class 2
·Hematology
Distal Hook Plate, Long, 7-Hole
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665024777·
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0130070·Rocker, One Piece
BELLEGLASS HP ENAMEL 2
FDA 510(k)
FDA Class 2
·Dental
GALAXY
FDA 510(k)
FDA Class 2
·Dental
ARROW CVC SET
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC.·Product code DQY·April 9, 2021
ARROW CVC SET
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL LLC·Product code DQY·November 11, 2022
ARROW CVC KIT: 5-LUMEN 8.5FR X 16CM
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL LLC·Product code FOZ·March 21, 2022
ARROW CVC SET: 16 GA X 8" (20 CM)
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL LLC·Product code DQY·September 21, 2022
CONSTELLATION VISION SYSTEM
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·March 7, 2013
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·March 25, 2011
CONTAK RENEWAL 3
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code NIK·May 8, 2008
ARROW CVC SET: 16 GA X 8" (20 CM)
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL LLC·Product code FOZ·May 10, 2022
ARROW CVC SET: 3-LUMEN 12 FR X 20 CM
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL LLC·Product code FOZ·March 24, 2022
ARROW CVC SET: 2-LUMEN 7 FR X 20 CM
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL LLC·Product code DQY·May 12, 2022
TC pCO2 Electrodes, Model/Part #945-655-E5260, 510(k) #K043003. Product Usage: The device is intended for used with the firm's TCM series monitor. The E260mpCO2 electrode is a non-invasive device, used with the TCM series monitor to measure transcutaneous pCO2 (through the skin).
FDA Recall
Terminated
·Radiometer America Inc·Product code LKD·September 27, 2011
ARROW CVC SET: 16 GA X 8" (20 CM)
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL LLC·Product code DQY·September 27, 2022
ARROW CVC SET: 3-LUMEN 7FR X 20CM
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL LLC·Product code DQY·January 17, 2023
ARROW CVC KIT: 2-LUMEN 7FR X 20CM
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC.·Product code DQY·January 16, 2018
ARROW CVC SET: 3-LUMEN 7 FR X 20 CM
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL LLC·Product code FOZ·June 23, 2022