10 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TSRH OFFSET AND SIDE-LOADING HOOKS
FDA 510(k)
FDA Class 2
·Orthopedic
Brigade
FDA UDI
Nuvasive, Inc.·00887517962737·Brigade Lateral Trial, 13x34x32mm 15°
BALL HEADS: BIPOLAR HEAD BIPOLAR HEAD Ø28X45
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KWY·January 20, 2020
BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
COLGATE DESENSITIZING DENTAL CREAM
FDA 510(k)
FDA Class 2
·Dental
FLOGARD
FDA Adverse Event
Malfunction
·SHARP CORPORATION OSAKA JAPAN·Product code FRN·June 30, 2014
PRODISC-C IMPLANT LARGE 5MM-STERILE
FDA Adverse Event
Injury
·Product code MJO·January 9, 2013
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·November 15, 2010
Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.
FDA Enforcement
Class III
·Terminated·Illumina Inc·December 31, 2014
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