21 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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G Surgical Marksman MIS System
FDA 510(k)
FDA Class 2
·Orthopedic
TALOS® HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B167321615160·
STAODYN MAX PRESET, MODEL 4470
FDA 510(k)
FDA Class 2
·Neurology
NMR LIPOPROFILE (R) TEST AND NMR PROFILER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PENTA
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 5, 2013
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 14, 2011
FLO-GARD 6301 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·September 17, 2008
FLEXIBLE NEURO-FIBERSCOPE, 3.7MM X 34CM, Model # 11282BN1
FDA Enforcement
Class II
·Terminated·Karl Storz Endoscopy·September 4, 2019
THREE PEG PATELLA 41MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·February 4, 2025
BD NANO¿ PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·March 4, 2019
BD NANO¿ 2ND GEN PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·February 7, 2022
Jackson-Pratt Silicone Flat Drain, 10mm Full W/Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·May 31, 2017
BD ULTRA FINE PEN NEEDLES
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·September 11, 2020
LOGIC CR TIB INSERT STD, SZ 5, 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·August 31, 2023
PEN NDL 32G 4MM 5B XTW BULK US W/EXPIRY
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·April 13, 2020
BD ULTRA-FINE¿ MINI PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·February 5, 2019
BD¿ ULTRA-FINE PEN NEEDLES
FDA Adverse Event
Injury
·BECTON DICKINSON AND CO.·Product code FMI·January 24, 2019
RELION PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FMI·March 25, 2021
BD ULTRA FINE¿ SHORT INSULIN PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·March 27, 2018
6MM X 32G PEN NEEDLE (ULTRAFINE MICRO)
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·March 11, 2021