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

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Audion ET dilation system

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

X-CORE

FDA UDI
Nuvasive, Inc.·00887517434241·X-CORE 2 Ti Core, Ø22x21-27mm

LEONE SPA

FDA UDI
LEONE SPA·08033707022213·CALIBRA BANDS 2ND MOLAR n.SUR 27

Symmetry Surgical

FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482045688·Symmetry® Retractor, Ribbon, Malleable, 1 in Wi...

Spex

FDA UDI
SPEX LIMITED·09420051700956·Spex 2 Point Padded Hip Belt, Dual Centre Pull,...

PILAIRO NASAL PILLOWS MASK

FDA 510(k)
FDA Class 2 ·Anesthesiology

FOCUS RADIATION TREATMENT PLANNING SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

MECTALIF ANTERIOR LAG PLATE FLUSH H12 MM

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code OVD·March 9, 2023

MECTALIF ANTERIOR LAG PLATE FLUSH H12 MM

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code OVD·March 9, 2023

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 12, 2025

STYLE 68 SALINE FILLED BREAST IMPLANT

FDA Adverse Event
Injury ·ALLERGAN (COSTA RICA)·Product code FWM·August 21, 2025

SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·November 3, 2014

INRATIO

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·July 13, 2011

QUADRA ASSURA CRT-D, DF4 CONNECTOR

FDA Adverse Event
Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 11, 2013

MRHK TIB INS 20MM XS/S S1/S2

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code KRO·October 28, 2025

DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·April 19, 2023

Model Number L111, ESSENTIO DR SL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025