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

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ADVANCED GLASS IONOMER (K-130) RESTORATIVE

FDA 510(k)
FDA Class 2 ·Dental

Medline Industries, Inc.

FDA UDI
MEDLINE INDUSTRIES, INC.·10193489206272·ENHANCED ISOLATION KIT SM-LG

Sklar®

FDA UDI
SKLAR CORPORATION·10649111338090·MIXING/SOLUTION BOWL 5 QT

StarBurst

FDA UDI
NAVILYST MEDICAL, INC.·H7877001014931·RITA StarBurst Electrosurgical Device

GUTTA PERCHA POINTS

FDA UDI
DiaDent Group International·08806383556217·Gutta Percha Points is used to root canal filin...

GUTTA PERCHA POINTS

FDA UDI
DiaDent Group International·08806383501231·Gutta Percha Points is used to root canal filin...

Sklar®

FDA UDI
SKLAR CORPORATION·30649111192221·MIXING/SOLUTION BOWL 5 QT PK12

DENTAL AIR FORCE HOME DENTAL CLEANING SYSTEM, MODEL NO. 0020001

FDA 510(k)
FDA Class 1 ·Dental

MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR BRACHYTHERAPY

FDA 510(k)
FDA Class 2 ·Radiology

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 2, 2013

FUJINON

FDA Adverse Event
FUJIFILM OPTICS CO., LTD. MITO FACTORY·Product code FDA·August 27, 2014

AS HUMERAL HEAD FX RIGHT 44

FDA Adverse Event
Injury ·ZIMMER GMBH·Product code HSD·May 17, 2011

Torcon NB

FDA UDI
COOK INCORPORATED·00827002470484·Torcon NB Advantage Catheter

B125M Patient Monitor, REF 6160000-005-XXXXXXX

FDA Enforcement
Class II ·Ongoing·GE Medical Systems, LLC·December 28, 2022

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

Model Number L101, ESSENTIO DR SL Pacemaker

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

Model Number U128, VALITUDE CRT-P EL MRI

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

Model Number L210 PROPONENT SR SL Pacemaker

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

Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·July 14, 2021

VALITUDE CRT-P pacemaker, Models: a) U125 b) U128

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·July 14, 2021