17 results · 22ms · Sources: EU EUDAMED, US FDA

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CONSTELLATION MULTIPLE ELECTRODE RECORDING & PACING CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

ForPro

FDA UDI
Tng Worldwide, Inc.·00672047000215·Vinyl Exam Gloves Size Small 100ct

SYRINGE 1.0ML 31GA 6MM

FDA Adverse Event
Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·May 19, 2020

SYRINGE 1.0ML 31GA 6MM 10BAG 500CS

FDA Adverse Event
Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·January 13, 2020

ELECSYS TROPONIN T STAT TEST

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)

FDA 510(k)
FDA Class 1 ·General Hospital

M2A-MAGNUM MODULAR HEAD SZ 42MM

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code KWA·May 31, 2013

UNKNOWN TRIDENT HIP REPLACEMENT

FDA Adverse Event
Malfunction ·STRYKER ORTHOPAEDICS CORK·Product code JDI·May 31, 2011

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·October 3, 2014

UNID ROD

FDA Adverse Event
Malfunction ·MEDICREA INTERNATIONAL SA·Product code MNI·July 29, 2024

UNID ROD

FDA Adverse Event
Malfunction ·MEDICREA INTERNATIONAL SA·Product code MNI·July 29, 2024

GALAFLEX

FDA Adverse Event
Injury ·TEPHA, INC·Product code OOD·February 28, 2020

BD VEO INSULIN SYRINGE WITH BD ULTRA-FINE 6MM NEEDLE

FDA Adverse Event
Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·January 13, 2020

BD VEO INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE

FDA Adverse Event
Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·December 20, 2019

C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear Accelerator is intended to provide sterotactic radiosurgery and precision radio-therapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·September 24, 2014

C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy linear accelerator; Versions 7, 8 and 9. The UNIQUE is not sold in the US. Product Usage: The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. The UNIQUE is a single energy medical linear accelerator. UNIQUE is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·December 11, 2013

Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc. Oncology Systems·May 22, 2013