19 results · 27ms · Sources: EU EUDAMED, US FDA

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Single Use Balloon Dilator V (with Knife)

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

AGXO

FDA UDI
Oticon A/S·05707131284853·H150V2, MINIRITE 312 WL TC AGXO

Vilex Guidewire

FDA UDI
VILEX IN TENNESSEE, INC.·00841731120526·Guidewire 1.4x150mm Dbl Trocar

Vilex Guidewire

FDA UDI
VILEX IN TENNESSEE, INC.·00841731120533·Guidewire 1.4x150mm Sgl Trocar

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197540339·Caspar Rongeur downwards angled 2x12mm 1 40mm

AEQUALIS REVERSED SHOULDER PROSTHESIS

FDA 510(k)
FDA Class 2 ·Orthopedic

RESMED MERIDIAN MASK

FDA 510(k)
FDA Class 2 ·Anesthesiology

ARCHITECT I2000SR ANALYZER

FDA Adverse Event
Malfunction ·ABBOTT MANUFACTURING INC·Product code JJE·November 4, 2013

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·October 30, 2020

BD NEXIVA¿ CLOSED IV CATHETER SYSTEM - DUAL PORT 20 GA 1.00 IN

FDA Adverse Event
Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·October 19, 2023

AMISTEM H CEMENTLESS STEM SIZE 3 LAT

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·December 22, 2015

TECNIS 1-PIECE

FDA Adverse Event
Injury ·ABBOTT MEDICAL OPTICS·Product code HQL·October 7, 2014

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 6, 2011

TENSION FREE VAGINAL TAPE

FDA Adverse Event
Injury ·ETHICON, INC.·Product code OTN·June 6, 2013

HAEMOLANCE LANCET

FDA Adverse Event
Injury ·HTL-STREFA S.A.·Product code FMK·October 3, 2011

BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

FDA Adverse Event
Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·September 27, 2023

BD NEXIVA¿ CLOSED IV CATHETER SYSTEM - DUAL PORT 20 GA 1.00 IN

FDA Adverse Event
Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·October 19, 2023

COBAS 8000 COBAS ISE MODULE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JGS·October 2, 2012

Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024