11 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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Altus Spine Cervical Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
Ceramco® II Silver™
FDA UDI
Dentsply International Inc.·D0011630610·
CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BIOMATE STERILE ACUPUNCTURE NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
STARKEY
FDA UDI
Starkey Laboratories, Inc.·00842318176899·
LIGACLIP** ENDOSCOPIC CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·June 11, 2013
FABIUS GS
FDA Adverse Event
Malfunction
·DRAEGER MEDICAL GMBH·Product code BSZ·July 6, 2011
CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code LWR·September 15, 2008
DREAMSTATION AUTO BIPAP
FDA Adverse Event
Injury
·RESPIRONICS, INC.·Product code BZD·May 3, 2022
PEDICLE SCREW LATERAL CONNECTOR L150
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·December 13, 2023
RECLAIM DISTAL TAPERED Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014