16 results · 25ms · Sources: EU EUDAMED, US FDA

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MATRICEL DENTAL BARRIER MEMBRANE

FDA 510(k)
FDA Class 2 ·Dental

NOVO Health Services, LLC

FDA UDI
NOVO HEALTH SERVICES, LLC·00812564039422·LP GOWNS, XLG 20 PK N/S

NOVO Health Services, LLC

FDA UDI
NOVO HEALTH SERVICES, LLC·00810019800870·Gown, L4 XL, 20-Pack NS

TORQTECH

FDA 510(k)
FDA Class 1 ·Dental

STERI-MATE STERILIZABLE HANDPIECE

FDA 510(k)
FDA Class 2 ·Dental

LOGIC FEMORAL PS POR RIGHT SZ 2

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·February 10, 2025

QUADROX-ID PEDIATRIC

FDA Adverse Event
Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·May 3, 2013

SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

FDA Adverse Event
Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 26, 2014

V60 VENTILATOR

FDA Adverse Event
Malfunction ·RESPIRONICS CALIFORNIA, INC.·Product code MNT·June 14, 2011

LOGIC CR FEMORAL POR, LEFT, SZ 3.5

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·December 11, 2024

EAGLE EYE PLATINUM SHORT TIP

FDA Adverse Event
Injury ·VOLCANO CORPORATION·Product code OBJ·July 1, 2016

EAGLE EYE PLATINUM SHORT TIP; EAGLE EYE PLATINUM ST CATHETER

FDA Adverse Event
Injury ·VOLCANO CORPORATION·Product code OBJ·July 1, 2016

EAGLE EYE PLATINUM SHORT TIP; EAGLE EYE PLATINUM ST CATHETER

FDA Adverse Event
Injury ·VOLCANO CORPORATION·Product code OBJ·July 1, 2016

LOGIC CR FEMORAL POR, RIGHT, SZ 3

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·May 14, 2019

SPECIFIC DEVICE NOT REPORTED

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·April 26, 2023

Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE

FDA Enforcement
Class II ·Ongoing·Electro Medical Systems SA·May 1, 2024