13 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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VARI-LASE ENDOVENOUS LASER CONSOLE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LEONE SPA
FDA UDI
LEONE SPA·08033707065845·EXTRAORAL ELASTICS 3/8" 8 oz
LEONE SPA
FDA UDI
LEONE SPA·08033707065678·INTRAORAL ELASTICS 2,5 oz 3/8" orange
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450619933·
SIMPLICITY CLASSIC WING QD INFUSION SET
FDA 510(k)
FDA Class 2
·General Hospital
JEWEL CAST PLUS
FDA 510(k)
FDA Class 2
·Dental
2008T HEMODIALYSIS SYS., WITH CDX
FDA Adverse Event
Malfunction
·CONCORD MANUFACTURING·Product code KDI·June 26, 2018
PROLIFT +M PELVIC FLOOR REPAIR
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTP·May 6, 2013
PRIMEADVANCED
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·September 16, 2014
ACRYSOF IQ TORIC
FDA Adverse Event
Malfunction
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·April 6, 2011
4.5MM CORTEX SCREW 40MM
FDA Adverse Event
Malfunction
·SYNTHES GRENCHEN·Product code HWC·August 25, 2017
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-33, c) 44, 47, 50, 53 head, Large, Item Number 314-02-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012