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