23 results · 24ms · Sources: EU EUDAMED, US FDA

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VARIAX 2 SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

3D SCANNER, MODEL 1230

FDA 510(k)
FDA Class 2 ·Radiology

MEDTRONIC STRATAVARIUS

FDA 510(k)
FDA Class 2 ·Neurology

CD OPEN SACRAL SCREW

FDA Adverse Event
Injury ·SOFAMOR DANEK EUROPE·Product code KWP·March 4, 1999

PSI KIT, INTRODUCER FOR PACER

FDA Adverse Event
Malfunction ·ARROW INTERNATIONAL, INC.·Product code DQX·June 29, 1992

LP/BONEPLATE, STRT,6-HOLES,.6M

FDA Adverse Event
Malfunction ·HOWMEDICA INC·Product code HRS·September 12, 1997

HOYER LIFT

FDA Adverse Event
Malfunction ·TED HOYER & COMPANY·Product code FNG·April 24, 1992

DURAPHASE (PENILE PROSTHESIS)

FDA Adverse Event
Injury ·DACOMED·Product code FAE·January 6, 1993

UNKNOWN

FDA Adverse Event
Malfunction ·PALL BIOMEDICAL PRODUCTS CORPORATION·Product code CAK·January 5, 1993

ZIMMER SKIN GRAFT MESHER

FDA Adverse Event
Malfunction ·ZIMMER SURGICAL·Product code GFD·September 13, 2013

CHEST TUBE

FDA Adverse Event
Injury ·ARGYLE·Product code BTS·July 10, 1992

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 4, 2014

OT ULTRALINK METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 28, 2011

RJO CENTURY

FDA Adverse Event
Injury ·CENTURY·Product code FNG·January 6, 1993

ADVIA CENTAUR XPT

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JJE·July 19, 2016

SPLIT RAIL BED SIDE RAIL

FDA Adverse Event
Death ·HILL-ROM·December 3, 1992

SUBCLAVEN CATHETER DEVICE

FDA Adverse Event
Malfunction ·IMPLANTABLE DEVICES, INC.·Product code LJT·August 3, 1992

Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG

FDA Enforcement
Class II ·Ongoing·ICU Medical Inc.·January 21, 2026

INPERSOL W/4.25% DEXTROSE

FDA Adverse Event
Injury ·ABBOTT LABORATORIES·Product code GBW·August 6, 1992