36 results
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25ms
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Sources: EU EUDAMED, US FDA
ISOBAR SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ISOLA
FDA UDI
DEPUY SPINE, LLC·10705034005959·ISOLA SPINE SYSTEM OPEN PEDICLE HOOK 4.75 x 5.0mm
CUSTOM PROCEDURE KIT
FDA UDI
MEDIVATORS INC.·40677964004467·The ENDO CARRY-ON Procedure Kit contains all of...
PediFlex
FDA UDI
ORTHOPEDIATRICS CORP.·00841132119556·2.5mm Flex Nail Cap SS
TUFF IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·May 14, 2025
TUFF IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·May 14, 2025
CARD GUARD PERSONAL ELECTROCARDIOGRAM TRANSMITTER, MODEL CG-6206/6306
FDA 510(k)
FDA Class 2
·Cardiovascular
JET PORT PLUS CATHETER SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 2, 2025
EVIS EUS ENDOSCOPIC ULTRASOUND CENTER
FDA Adverse Event
Injury
·SHIRAKAWA OLYMPUS CO., LTD.·Product code IYN·September 30, 2024
TUFF IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·May 6, 2024
RESTORE SENSOR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·March 12, 2013
ATTAIN OTW
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 24, 2011
MICRO DRIVER RX CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MAF·February 21, 2008
INSORB 30 STAPLER
FDA Adverse Event
Injury
·COOPERSURGICAL, INC.·Product code GDW·November 1, 2023
BrightView XCT: product code 882482, BrightView X- upgraded with the XCT Flat Panel Detector (FPD): product code 882454. Gamma camera for Single Photon Emission Computed Tomography (SPECT) Medical Device for imaging.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·July 9, 2014
BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015
BrightView XCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015
BrightView XCT
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·February 22, 2017
BrightView XCT , Model Number 882482
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·July 31, 2019