19 results · 32ms · Sources: EU EUDAMED, US FDA

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Normal Saline Flush

FDA 510(k)
FDA Class 2 ·General Hospital

AGXO

FDA UDI
Oticon A/S·05707131284860·H150V2, MINIRITE 312 WL DBL 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·04049197540346·Caspar Rongeur downwards angled 3x12mm 1 40mm

OMNIPRO SYSTEM

FDA 510(k)
FDA Class 2 ·Neurology

PILOT DIODE LASER, MODEL 002-00139

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

SERVO VENTILATOR 300

FDA Adverse Event
Malfunction ·SIEMENS-ELEMA AB/LIFE SUPPORT SYSTEMS DIVISION·Product code CBK·May 16, 2003

PLATE COLUMBIA AG 5PRCT SB 90MM

FDA Adverse Event
Malfunction ·BECTON DICKINSON GMBH·Product code KZI·August 31, 2023

UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code JJE·February 18, 2010

BD NEXIVA

FDA Adverse Event
Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·November 18, 2023

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·June 6, 2013

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE·Product code KDJ·July 6, 2011

AES ULTRA

FDA Adverse Event
AES , INC·Product code CAE·August 20, 2008

VERSAFITCUP CC TRIO NO-HOLE ACETABULAR SHELL Ø 54

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·February 15, 2017

OT ULTRA2 METER

FDA Adverse Event
Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 4, 2014

STEM: AMISTEM H HA COATED LAT STEM SIZE 3

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·April 29, 2019

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