23 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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