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

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TI NASAL MASK

FDA 510(k)
FDA Class 2 ·Anesthesiology

Argyle

FDA UDI
Cardinal Health, Inc.·10884527002504·Open Suction Mini Tray with Directional Valve

Argyle

FDA UDI
Cardinal Health 200, LLC·10192253041736·Argyle Open Suction Mini Tray with Directional ...

ALLOMATRIX C PUTTY, ALLOMATRIX CUSTOM PUTTY, ALLOMATRIX DR PUTTY, IGNITE SCAFFOLD, MODELS 860C, 86XC, 86DR, 860D, 860T

FDA 510(k)
FDA Class 2 ·Orthopedic

INVADER FACTOR V

FDA 510(k)
FDA Class 2 ·Hematology

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·June 5, 2025

BD¿ PRE-FILLED NORMAL SALINE SYRINGE

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·June 4, 2020

SYRINGE 10ML SALINE FILL CHINA SP

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·June 3, 2020

INFUSOR

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·June 3, 2013

EXTENSION, DUAL 4 CHANNEL 10CM

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 21, 2011

BHR

FDA Adverse Event
Injury ·SMITH & NEPHEW ORTHOPAEDICS LTD., UK·Product code KWY·August 28, 2008

BD POSIFLUSH NORMAL SALINE SYRINGE

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·November 5, 2020

TOTAL KNEE REPLACEMENT

FDA Adverse Event
Malfunction ·STANMORE IMPLANTS WORLDWIDE LTD·Product code KRO·November 10, 2016

PATIENT SPECIFIC TOTAL FEMUR

FDA Adverse Event
Injury ·STANMORE IMPLANTS WORLDWIDE·Product code KRO·August 15, 2018

TWIST DRILL

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code HBE·September 18, 2017

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