23 results · 31ms · Sources: EU EUDAMED, 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