13 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ZODIAC SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DD base P HI
FDA UDI
Dental Direkt GmbH·EDDIK508301·DD medical polymers (PMMA), made from PMMA, are...
Neo-Tee T-Piece Resuscitator
FDA UDI
MERCURY ENTERPRISES, INC.·10641043508305·
neoWave LS
FDA UDI
XENIX MEDICAL LLC·00818345023888·BAYONETTED PUSH SCRAPER CURETTE
CANNULATION TOURNIQUET SET, 2 TUBE OR 5 TUBE
FDA 510(k)
FDA Class 2
·Cardiovascular
POWDER FREE TEXTURED VINYL EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFTS
FDA Adverse Event
Malfunction
·ANGIOMED GMBH & CO. MEDIZINTECHNIK·Product code JCT·May 22, 2009
CONNECSCR F/INSERTION DHS BLADE
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code LXH·April 10, 2013
RIATA ACTIVE FIXATION LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·May 27, 2008
ICL (IMPLANTABLE COLLAMER LENS)
FDA Adverse Event
Injury
·STAAR SURGICAL CO.·Product code MTA·April 1, 2011
ECC.O SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL
FDA Adverse Event
SORIN GROUP ITALIA·Product code KFM·February 29, 2016
Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 360 mm, Item Number: 814309360
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 19, 2018
Mercury Medical Neo-Tee T-Piece Resuscitator and T-Piece Circuit. The Neo-Tee T-Piece Resuscitator is a gas powered emergency resuscitator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway. It is intended for use with neonates and infants weighing less than 10kg (22 lb). The T-piece resuscitator circuit is a component used in conjunction with the T-piece resuscitator devices
FDA Enforcement
Class II
·Terminated·Mercury Enterprises, Inc. dba Mercury Medical·January 20, 2016