18 results · 21ms · Sources: EU EUDAMED, 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