26 results · 23ms · Sources: EU EUDAMED, US FDA

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Fiji Anchor

FDA 510(k)
FDA Class 2 ·Orthopedic

Sklar®

FDA UDI
SKLAR CORPORATION·10649111135507·CARROLL ARTERY FORCEPS 3.5"

Symmetry Mixter

FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482056837·Symmetry® Forceps, Mixter Right Angle, w/Serrat...

DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code PQF·January 16, 2018

MIRADA XD

FDA 510(k)
FDA Class 2 ·Radiology

FIDELITY 200 CARDIAC EVENT RECORDER

FDA 510(k)
FDA Class 2 ·Cardiovascular

IGG ANTIBODIES TO RUBELLA VIRUS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFX·August 26, 2013

COOK-SWARTZ DOPPLER PROBE

FDA Adverse Event
Injury ·COOK VANDERGRIFT INC·Product code ITX·May 11, 2022

CAPSUREFIX

FDA Adverse Event
Injury ·MPRI·Product code DTB·April 7, 2016

DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code PQF·January 25, 2018

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 14, 2013

COULTER LH 750 HEMATOLOGY ANALYZER

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·July 1, 2011

ENTERRA

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LNQ·September 22, 2008

COOK-SWARTZ DOPPLER PROBE

FDA Adverse Event
Injury ·COOK VANDERGRIFT INC·Product code ITX·November 23, 2022

POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 5676300

FDA Enforcement
Class II ·Completed·Bard Peripheral Vascular Inc·May 16, 2018

COOK-SWARTZ DOPPLER PROBE

FDA Adverse Event
Injury ·COOK VANDERGRIFT INC·Product code ITX·August 9, 2023

POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 1676300

FDA Enforcement
Class II ·Completed·Bard Peripheral Vascular Inc·May 16, 2018

POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with open suture holes, REF 5678300

FDA Enforcement
Class II ·Completed·Bard Peripheral Vascular Inc·May 16, 2018

POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with open suture holes, REF 5678301

FDA Enforcement
Class II ·Completed·Bard Peripheral Vascular Inc·May 16, 2018

BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 200 MM, Silicone, Sterile, Item 431197.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020