23 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.018
FDA 510(k)
FDA Class 2
·Cardiovascular
EVONOS
FDA UDI
Gyrus ACMI, LLC·00821925016330·GOLDMAN LARGE BALL PROBE
N/A
FDA UDI
Tyber Medical, LLC·M695M1304140·
Responsive Orthopedics Total Knee Arthroplasty System
FDA UDI
RESPONSIVE ORTHOPEDICS, LLC·00841973101222·Poly Insert PS, Size 4, 14mm
PROTOE ENDOSORB SMALL HAMMER TOE PIN
FDA 510(k)
FDA Class 2
·Orthopedic
GENIE ULTRA HYDROPHILIC IMPRESSION MATERIAL
FDA 510(k)
FDA Class 2
·Dental
SURESCAN CAPSUREFIX
FDA Adverse Event
Malfunction
·MEDTRONIC, INC·Product code DTB·May 13, 2013
XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·September 30, 2014
UNKNOWN ZIMMER HIP
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JDI·June 13, 2011
LOGIC CR TIB INSERT STD, SZ 2.5, 11MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·August 3, 2023
LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC. - 3015876·Product code MKJ·September 25, 2018
KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 20 devices/case Size 2 / Infant ClearSeal Flexible King LAD¿ Patient Size: 10-20kg Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012
H30 HOLMIUM LASER 30 WATT HOLMIUM LASER
FDA Adverse Event
Malfunction
·COOK INC·Product code GEX·October 30, 2017
H30 HOLMIUM LASER 30 WATT HOLMIUM LASER
FDA Adverse Event
Malfunction
·COOK INC·Product code GEX·February 9, 2018
H30 HOLMIUM LASER 30 WATT HOLMIUM LASER
FDA Adverse Event
Injury
·COOK INC·Product code GEX·February 28, 2018
H30 HOLMIUM LASER 30 WATT HOLMIUM LASER
FDA Adverse Event
Malfunction
·COOK INC·Product code GEX·February 8, 2018
H30 HOLMIUM LASER 30 WATT HOLMIUM LASER
FDA Adverse Event
Injury
·COOK INC·Product code GEX·April 25, 2018
DuraGen Plus Dural Regeneration Matrix DuraGen Plus Adhesion Barrier Matrix is an absorbable implant for repair and restoration of dural defects and as an adhesion barrier for the reduction of peridural fibrosis. DuraGen Plus matrix is an easy to handle, soft, white pliable, non-friable, porous, collagen matrix. DuraGen Plus matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corporation·May 22, 2013
ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11319151
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code CEK·July 29, 2024
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11097543
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code CEK·July 29, 2024