16 results · 31ms · Sources: EU EUDAMED, US FDA

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MONOFILAMENT POLYPECTOMY SNARE

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

Gyrus ACMI

FDA UDI
Gyrus ACMI, LLC·00821925016521·PISTON WITH ARMSTRONG PLATINUM RIBBON LOOP .6MM...

RESECT MEDICAL INLINE BI-POLAR RF LINEAR COAGULATION DEVICE

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCH BP HOME N BP3MX1-4

FDA 510(k)
FDA Class 2 ·Cardiovascular

EQUINOXE

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWT·August 26, 2019

ADMINISTRATION SET FOR HALO AMBULATORY INFUSION PUMP (TRADE NAME NIMBUS FLEX)

FDA Adverse Event
Malfunction ·INFUTRONIX, LLC·Product code FPA·November 21, 2018

ADMINISTRATION SET FOR HALO AMBULATORY INFUSION PUMP (TRADE NAME NIMBUS FLEX)

FDA Adverse Event
Malfunction ·INFUTRONIX, LLC·Product code FPA·November 21, 2018

ADMINISTRATION SET FOR HALO AMBULATORY INFUSION PUMP (TRADE NAME NIMBUS FLEX)

FDA Adverse Event
Malfunction ·INFUTRONIX, LLC·Product code FPA·November 21, 2018

NAVI XIA MODULAR TAP 5.5MM

FDA Adverse Event
Malfunction ·STRYKER SPINE-FRANCE·Product code HAW·March 30, 2015

ADMINISTRATION SET FOR HALO AMBULATORY INFUSION PUMP (TRADE NAME NIMBUS FLEX)

FDA Adverse Event
Malfunction ·INFUTRONIX LLC·Product code FPA·October 30, 2017

EQUINOXE

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWT·February 6, 2019

STAR S4 IR EXCIMER LASER

FDA Adverse Event
Injury ·ABBOTT MEDICAL OPTICS·Product code LZS·May 31, 2013

SECURE 3 MED/SURG BED

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FNL·June 15, 2011

9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS, INC.·Product code JAA·September 3, 2008

EQUINOXE SHOULDER COMPONENTS

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWS·January 9, 2024

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