18 results · 28ms · Sources: EU EUDAMED, US FDA

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binx health io CT/NG Assay

FDA 510(k)
FDA Class 2 ·Microbiology

Integra® Miltex®

FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780418771·Integra® Miltex® Lempert Endaural Curette, 8-1/...

Sklar®

FDA UDI
SKLAR CORPORATION·10649111386480·TISSUE FCP FLUTED HDL 5.5" 1X2

IN-OVATION® Mini

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K191552811·IN-OVATION® mini EURO 022/5-5 CS HK

IN-OVATION® Mini

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K191552821·IN-OVATION® mini EURO 022/5-5 CBC HK

In-Ovation ® Mini

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807191352101·IN-OVATION® mini Base Rx 022/LR5-22T -1A 4D HK

In-Ovation ® Mini

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807191352001·IN-OVATION® mini Base Rx 022/LR5-22T -1A 4D

In-Ovation ® Mini

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807191352801·IN-OVATION® mini EURO 022/LR5 -17T 2A

In-Ovation ® Mini

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807191352811·IN-OVATION® mini EURO 022/LR5-17T 2A HK

In-Ovation ® Mini

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D80719135200R1·IN-OVATION® mini Rhodium Base Rx 022/LR5-22T -...

TALON DISTALFIX PROXIMAL FEMORAL NAIL

FDA 510(k)
FDA Class 2 ·Orthopedic

SOUNDSTAR 3D DIAGNOSTIC CATHETER, MODEL M-5723-05

FDA 510(k)
FDA Class 2 ·Cardiovascular

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 21, 2025

GE OEC 9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·October 9, 2008

ACTIVA

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·June 26, 2013

WAVELIGHT FS200 FEMTOSECOND LASER

FDA Adverse Event
Malfunction ·WAVELIGHT GMBH·Product code LZS·July 27, 2011

ZOLL IVTM ICY CATHETER

FDA Adverse Event
Malfunction ·ZOLL CIRCULATION INC·Product code NCX·February 7, 2024

Medtronic MiniMed(TM) Silhouette(TM) (MMT-377, 377T, 378, 378T, 384, 384T, 368, 368T, 381, 381T, 382, 382T, 383, 383T)

FDA Enforcement
Class II ·Ongoing·Medtronic Inc.·November 29, 2017