34 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COBAS C 111 ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496071211·STRIPE GAME ALTAIR, SIZE S, NERO, GRADUATED COM...
NA
FDA UDI
KEY SURGICAL, INC.·10849771049408·K-Wires, Double diamond, .035-inch (0.9mm) diam...
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704293036·
mahe medical GmbH
FDA UDI
mahe medical gmbh·04050659484542·K-Wire w. double end lanzet point _x000D_...
K-Wire w. double end lanzet point 0.9mm/229mm, 6 pcs./unit
FDA UDI
mahe medical gmbh·EMAHKM712110·K-Wire w. double end lanzet point
0.9mm/...
Sklar®
FDA UDI
SKLAR CORPORATION·10649111090066·MILLER ENG-STYLE STAND SIZE 00
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0112110·Tap, Cannulated, 4.75 mm
FLOWABLE COMPOSITE/ ECUFLOW/ LUXAFLOW
FDA 510(k)
FDA Class 2
·Dental
MODIFICATION TO INTRALASE 600C LASER KERATOME
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INTACS PRESCRIPTION INSERTS
FDA Adverse Event
Injury
·ADDITION TECHNOLOGY, INC.·Product code LQE·June 20, 2006
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 26, 2023
*
FDA Adverse Event
Malfunction
·RICHARD WOLF MEDICAL INSTRUMENTS CORP·Product code GEI·May 29, 2015
RESTORE ULTRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 22, 2013
CAPSURE SP NOVUS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·April 27, 2011
CORODYN A
FDA Adverse Event
Other
·B. BRAUN MEDICAL, INC.·Product code DYG·July 3, 2008
INTACS PRESCRIPTION INSERTS
FDA Adverse Event
Injury
·ADDITION TECHNOLOGY, INC.·Product code LQE·April 3, 2006
cobas 8000 analyzer series Operators Manual Roche cobas Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014
INTACS CORNEAL IMPLANTS
FDA Adverse Event
Injury
·ADDITION TECHNOLOGY, INC.·Product code LQE·June 20, 2006
INTACS PRESCRIPTION INSERTS
FDA Adverse Event
Injury
·ADDITION TECHNOLOGY, INC.·Product code LQE·April 3, 2006