18 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VDRIVE WITH V-LOOP/ VDRIVE DUO
FDA 510(k)
FDA Class 2
·Cardiovascular
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319705018·Baby Allis Tissue Forceps 5-1/2" (13.8cm), 4x5 ...
AMT G-J TUBE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
.DECIMAL TISSUE COMPENSATOR/INTENSITY MODULATOR
FDA 510(k)
FDA Class 2
·Radiology
MICROFRANCE® INSTRUMENT
FDA Adverse Event
Malfunction
·XOMED MICROFRANCE MFG·Product code GEI·April 15, 2015
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·May 31, 2013
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·May 31, 2011
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS, INC.·Product code JAA·September 3, 2008
ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·February 12, 2015
INFINION CX
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 14, 2020
POLARIS SCREW, DIA. 6.5 X UNKNOWN LENGTH
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE, INC.·Product code NKB·May 28, 2025
POLARIS SCREW, DIA. 6.5 X UNKNOWN LENGTH
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE, INC.·Product code NKB·May 28, 2025
POLARIS SCREW, DIA. 6.5 X UNKNOWN LENGTH
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE, INC.·Product code NKB·May 28, 2025
POLARIS SCREW, DIA. 6.5 X UNKNOWN LENGTH
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE, INC.·Product code NKB·May 28, 2025
Peritoneal Lavage Kits, Model number AK-09000
FDA Recall
Terminated
·Arrow International Inc·Product code GBW·August 2, 2004
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