13 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IGD DIAGNOSTIC TEST KITS
FDA 510(k)
FDA Class 2
·Immunology
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450140994·
SMITH AND NEPHEW 5.00MM ABSORBABLE POLYMER ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
PLAIN AND CHROMIC GUT ABSORBABLE SURGICAL SUTURES USP
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BD INSULIN PEN NEEDLE
FDA Adverse Event
Injury
·BECTON DICKINSON AND CO.·Product code FMI·November 9, 2015
TRIATHLON #2 PS INSERT 11MM
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·April 10, 2013
TRUFIT BGS PLUG
FDA Adverse Event
Other
·SMITH & NEPHEW, INC.·Product code MQV·May 22, 2008
EON MINI RECHARGEABLE IPG
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION DIV·Product code LGW·April 7, 2011
BD MAXPLUS¿ PRESSURE RATED EXTENSION SET WITH REMOVABLE NEEDLELESS CONNECTOR
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·January 3, 2023
BD MAXPLUS¿ PRESSURE RATED EXTENSION SET WITH REMOVABLE NEEDLELESS CONNECTOR
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·January 3, 2023
HENRY SCHEIN
FDA Adverse Event
Malfunction
·A.R. MEDICOM INC. (SHANGHAI) LTD.·Product code FXX·December 12, 2016
HENRY SCHEIN SOFT EARLOOP FACE MASK
FDA Adverse Event
Other
·A.R. MEDICOM·Product code FXX·July 27, 2012
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