213 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Blood Collection Needle for Single Use & Blood Collection Needle with Holder for Single Use, Safety Blood Collection Needle for Single Use, Safety Blood Collection Needle with Holder for Single Use, Blood Collection Set for Single Use & Safety Blood Collection Set with Holder for Single Use, Safety Blood Collection Set for Single Use & Blood Collection Set with Holder for Single
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MEGA5.5 SPINE SYSTEM
FDA UDI
BK MEDITECH CO.,LTD.·08809228125753·Rod, Ø5.5 x 190mm
Micro Quick Release Stem Impactor
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215055813·
COLOR BUFFED (CB) DDH FEMORAL STEM
FDA 510(k)
FDA Class 2
·Orthopedic
BENCOX ID STEM, BENCOX METAL HEAD, BENCOX BIPOLAR CUP
FDA 510(k)
FDA Class 2
·Orthopedic
OVERJET CARIES ASSIST
FDA Adverse Event
Malfunction
·OVERJET·Product code MYN·February 18, 2025
UNKNOWN CATHETER
FDA Adverse Event
Injury
·MEDTRONIC NEUROSURGERY·Product code JXG·December 21, 2018
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 29, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 15, 2011
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code ITI·July 8, 2013
UNKNOWN VALVE/SHUNT
FDA Adverse Event
Injury
·MEDTRONIC NEUROSURGERY·Product code JXG·December 21, 2018
UNKNOWN CATHETER
FDA Adverse Event
Injury
·MEDTRONIC NEUROSURGERY·Product code JXG·December 21, 2018
BD NANO¿ 2ND GEN PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·November 22, 2022
BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT)
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·October 25, 2023
BD NANO¿ 2ND GEN PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·February 14, 2022
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 25, 2019
Breast Pack, part number AMS3238(A Breast Pack, part number AMS4419(A Breast Pack, part number AMS4419(B Breast Pack, part number AMS5750 Breast Pack, part number AMS5750(A Breast Pack, part number AMS6120 Breast Pack, part number PSS1784(B Breast Pack, part number PSS2272(A
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Thio Med w/Dex, Hem, Vit K (5ml) 100/PK Product Usage; Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
FDA Enforcement
Class II
·Terminated·Remel Inc·May 29, 2019
Head/Neck Pack, part number AMS6121
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Plastic Surgery Pack, part number AMS5685
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017