36 results · 25ms · Sources: EU EUDAMED, US FDA

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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