11 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496030966·STRONG, SIZE L, FUMO, MICRO-MASSAGING BERMUDA S...
Lateral Vaginal Wall Retractor Open
FDA UDI
MEDGYN PRODUCTS, INC.·M803030966·Wall Retractor Open 1/2" (13mm), 10" (254mm), B...
WUNDCATH CONDUCTION CATHETER
FDA 510(k)
FDA Class 2
·General Hospital
4631 DUO DELIVERY SYSTEM
FDA 510(k)
FDA Class 1
·Dental
ARCHITECT C8000 SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING INC·Product code CGZ·April 2, 2013
ECHELON*FLEX60 LONG
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·March 28, 2011
DEEP BRAIN STIMULATION LEAD
FDA Adverse Event
Malfunction
·MPROC, VILLALBA·Product code MHY·April 17, 2008
TI CERVICAL SPINE LOCKING PLATE 45MM (37MM)
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code KWQ·September 9, 2015
Brand Name: Canturio¿ Smart Extension Product Name: CSE Implant Model/Catalog Number: 43-5570-030-14 Product Description: Tibial stem extension for use with Zimmer Persona¿ Personalized Knee System; 14mm diameter x 30mm height. Implantable device with integrated electronics for passive kinematic data collection. Single-use, sterile. Packaged in a sterile blister and outer shelf pack. Sold individually. Component: Yes. The Canturio¿ Smart Extension (CSE) is a tibial implant component intended for use with the Zimmer Persona¿ Personalized Knee System.
FDA Enforcement
Class II
·Ongoing·Canary Medical, Inc.·July 16, 2025
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