14 results · 20ms · Sources: EU EUDAMED, US FDA

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SUPERCABLE GRIP AND PLATE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

Genius Total Knee System

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215021924·

Crescendo Meniscal Insert CR Ultracongruent 11mm Size 0

FDA UDI
AMPLITUDE SAS·03701089524650·

RAICHEM MULTI-ANALYTE CALIBRATOR

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

GEOFORM ANNULOPLASTY RING, MITRAL MODEL 4200

FDA 510(k)
FDA Class 2 ·Cardiovascular

DXTEND GLENOSPHERE STD D42MM

FDA Adverse Event
Injury ·DEPUY FRANCE·Product code KWS·December 6, 2012

3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 16MM

FDA Adverse Event
Injury ·SYNTHES USA·Product code HTT·April 23, 2013

CAPSUREFIX NOVUS

FDA Adverse Event
Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·April 28, 2011

TRANSVENE

FDA Adverse Event
Injury ·MEDTRONIC, INC.·Product code LWS·July 10, 2008

EVOLUT FX DCS

FDA Adverse Event
Malfunction ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·June 27, 2025

DISP.TROCAR THRD.W.DILATING PIN 12/110MM

FDA Adverse Event
Malfunction ·AESCULAP AG·Product code GCJ·July 9, 2019

BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHYSIOLOGY CATHETER

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

AC TenderLink 13/30 10 pcs; AC TenderLink I 13/60 10 pcs; AC TenderLink I 13/80 10 pcs; AC TenderLink I 17/110 10 pcs; AC TenderLink I 17/30 10 pcs; AC TenderLink I 17/60 10 pcs; AC TenderLink I 17/80 10 pcs; AC TenderLink I 13/110 10 pcs The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin

FDA Enforcement
Class II ·Terminated·Unomedical As·November 9, 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