19 results · 27ms · Sources: EU EUDAMED, US FDA

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LASER 3 SPSC300

FDA 510(k)
FDA Class 2 ·Physical Medicine

Premier Carvers

FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·00348783009231·Carver DE_Hollenback 3S(1/2)

GEN4 DIGITAL

FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828145299·GEN4 DIGITAL

GEN4 INTERACTIVE

FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828114981·GEN4 INTERACTIVE

GEN4 Direct Access

FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828102179·GEN4 Direct Access

MULTI ADJUSTABLE FACE MASK

FDA 510(k)
FDA Class 2 ·Dental

BROTHERS POWDER-FREE VINYL EXAMINATION GLOVES

FDA 510(k)
FDA Class 1 ·General Hospital

INFINION? PRO

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·October 17, 2025

MultiPolar®

FDA UDI
Zimmer, Inc.·00889024116191·

ZPower Rechargeable System for Hearing Aids

FDA UDI
ZPOWER, LLC·00811204030157·Charger for ZPower Rechargeable System for Hear...

V500, SAVINA AND VENTILATORS OF EVITA FAMILY

FDA Adverse Event
Other ·DRAGER MEDICAL GMBH·Product code CBK·February 18, 2011

ALLOFT-S ALLOCLASSIC SHL 52/II

FDA Adverse Event
Malfunction ·ZIMMER GMBH·Product code JDI·March 12, 2019

POWERED WHEELCHAIR

FDA Adverse Event
Malfunction ·INVACARE TAYLOR STREET·Product code ITI·March 13, 2013

APEX MONORAIL

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·February 28, 2011

BD FIRST PICC PERIPHERALLY INSERTED CENTRAL CATHETER

FDA Adverse Event
Other ·BECTON DICKINSON INFUSION THERAPY SYSTEMS·Product code LJS·February 22, 2008

ALLOFIT-S ALLOCLASSIC, SHELL WITH POLAR SCREW PLUG, UNCEMENTED, 52/II

FDA Adverse Event
Injury ·ZIMMER GMBH·Product code LZO·September 27, 2018

Nuclear gamma cameras (ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60 & ADAC CARDIO C60) Nuclear gamma cameras intended to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes with the human body for interpretation by medical personnel.

FDA Enforcement
Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·May 20, 2015

Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

FDA Enforcement
Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024