21 results · 36ms · Sources: EU EUDAMED, US FDA

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ELECSYS HCG+B CALCHECK

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

Henry Schein

FDA UDI
HENRY SCHEIN, INC.·00304040075982·Carbide Bur FG Clinic 330

BUSCH®, BNA®

FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120102371·Steel - Excavating burs

HANISCH MEDICAL

FDA UDI
Hanisch Medical Ltda·07898663495751·H37-TRAY(30) F/INST.STANDER---BEIGE

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450216149·

InTess Lumbar Cage

FDA UDI
Kalitec Direct LLC·B07312K0102070·Shaver, Open 7mm

DAISY FUENTES

FDA UDI
FGX INTERNATIONAL INC.·00193033116081·

DAISY FUENTES

FDA UDI
FGX INTERNATIONAL INC.·00193033116074·

neoWave LS

FDA UDI
XENIX MEDICAL LLC·00818345023901·PADDLE SPREADER, 7MM

DAISY FUENTES

FDA UDI
FGX INTERNATIONAL INC.·00193033116067·

EQUINOX OCCLUSION BALLOON CATHETER/SYSTEM - (10MM BALLOON, 4 & 13 MM TIP), (15 MM BALLOON, 4 & 13 MM TIP), (20 MM BALLOO

FDA 510(k)
FDA Class 2 ·Cardiovascular

EHC 400 DESKTOP PATIENT STATION, EHC 600 CORE PROVIDER STATION

FDA 510(k)
FDA Class 2 ·Cardiovascular

HENRY SCHEIN INC

FDA Adverse Event
Malfunction ·PRIMA DENTAL GROUP·Product code EJL·June 19, 2025

GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·September 6, 2022

G7 HI-WALL E1 LINER 32MM C

FDA Adverse Event
Malfunction ·ZIMMER BIOMET, INC.·Product code PBI·February 22, 2023

DISTAL FEMUR LISS INSERTION GUIDE-LEFT

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code FZX·March 19, 2013

INRATIO

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·February 11, 2011

BRAUN

FDA Adverse Event
Malfunction ·BRAUN·Product code JEQ·March 7, 2008

Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022

Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

FDA Enforcement
Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014