10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VALVE CONTROLLER FOR MICROMACRO COMPOUNDER
FDA 510(k)
FDA Class 2
·General Hospital
LEADER
FDA UDI
Cardinal Health 110, Inc.·00096295124101·Antibacterial Neon Adhesive Bandages; Helps Pre...
CORDIS SLALOM PTA BALLOON CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
PR CREAM
FDA 510(k)
FDA Unclassified
·Unknown
PRECISE SDS SELF EXPANDING
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code FGE·June 30, 2014
EON
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·January 2, 2013
CONQUEST PTA BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·November 11, 2010
Cardio Medical Products, Inc. Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrode Rx Only Single Patient Use Only Manufactured for Cardio Medical Products 385 Franklin Avenue, Suite L Rockaway, New Jersey 07866 www.cardiomedicalproducts.com (800) 227-3633 (973) 586-9624 FAX Defibrillator
FDA Enforcement
Class II
·Terminated·Cardio Medical Products·July 17, 2013
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024