12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ULTRAVIEW DM3 MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450593585·
HYSTEROSCOPES
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
FRC POSTEC
FDA 510(k)
FDA Class 1
·Dental
MEDACTA KNEE IMPLANTS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·January 28, 2016
BD VACUTAINER® K2E 10.8MG PLUS BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·August 9, 2023
2008T HEMODIALYSIS SYS., WITH CDX
FDA Adverse Event
Malfunction
·CONCORD MANUFACTURING·Product code KDI·June 26, 2018
ACCUCHECK AVIVA
FDA Adverse Event
Injury
·ROCHE LABORATORIES·Product code LFR·May 11, 2011
ALLEGRETTO WAVE EYE-Q
FDA Adverse Event
Injury
·WAVELIGHT GMBH·Product code LZS·April 30, 2013
RADIOLUCENT INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS
FDA Adverse Event
Malfunction
·SYNTHES HAGENDORF·Product code LXH·September 16, 2014
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-23, c) 44, 47, 50, 53 head, Large, Item Number 314-02-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-25; 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