11 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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