16 results · 32ms · Sources: EU EUDAMED, US FDA

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BIOTENE MOISTURIZING MOUTH SPRAY FOR DRY MOUTH SYMPTOM RELIEF

FDA 510(k)
FDA Unclassified ·Unknown

Silex

FDA UDI
SILEX MEDICAL, LLC·B331EZL103745·Slide Locking Long Stone Cup Dissecting Forceps

SELF CENTERING

FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295003588·SELF CENTERING BI-POLAR HEAD 22.225mm ID 45mm OD

LARYNGEAL SURFACE ELECTRODE-ENDOTRACHEAL TUBE, M-500-ET, LSE-ET

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

LIFEBED NETWORK PATIENT VIGILANCE SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

GORE EXCLUDER AAA ENDOPROSTHESIS

FDA Adverse Event
Injury ·W. L. GORE & ASSOCIATES·Product code MIH·December 21, 2012

FETAL MONITOR/CARDIOTOCOGRAM

FDA Adverse Event
Injury ·BISTOS CO., LTD.·Product code HGL·January 29, 2018

TAPERLOC COMPLETE

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWA·October 1, 2025

ALLEGRA

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code JQC·September 25, 2015

OT ULTRALINK METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 9, 2013

ACRYSOF

FDA Adverse Event
Other ·ALCON RESEARCH LTD./HUNTINGTON·Product code HQL·May 19, 2011

TAPERLOC COMPLETE

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWA·November 5, 2025

Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiology Departments. The BrainLAB Cranial IGS System is intended to be an intra-operative image guided localization system to enable minimally invasive surgery.

FDA Enforcement
Class I ·Terminated·Brainlab AG·January 27, 2016

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

VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021