14 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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