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

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BLAKSTONE LAMINOPLASTY FIXATION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

Symmetry Nelson Metzenbaum

FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482051498·Symmetry® Scissors, Nelson Metzenbaum Dissectin...

PORTAPRES AMBULATORY CONTINUOUS NON INVASIVE BLOOD PRESSURE MONITOR,MODEL-2

FDA 510(k)
FDA Class 2 ·Cardiovascular

BIO-EYE II ORBITAL IMPLANT

FDA 510(k)
FDA Class 2 ·Ophthalmic

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·February 21, 2025

COGNIS

FDA Adverse Event
Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·April 9, 2013

INFINITI VISION SYSTEM OZIL

FDA Adverse Event
Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·February 25, 2011

FINELINE II

FDA Adverse Event
Malfunction ·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 2008

BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER

FDA Enforcement
Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

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

Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

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