25 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CD HORIZON SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Zavation
FDA UDI
Zavation LLC·00842166108806·PLIF-C 9x32 Convex -15
Zavation
FDA UDI
Zavation LLC·00842166108769·PLIF-C 9x32 Convex -11
Zavation
FDA UDI
Zavation LLC·00842166108738·PLIF-C 9x32 Convex -8
Zavation
FDA UDI
Zavation LLC·00842166108783·PLIF-C 9x32 Convex -13
Zavation
FDA UDI
Zavation LLC·00842166108752·PLIF-C 9x32 Convex -10
Zavation
FDA UDI
Zavation LLC·00842166108813·PLIF-C 9x32 Convex -16
Zavation
FDA UDI
Zavation LLC·00842166108790·PLIF-C 9x32 Convex -14
Zavation
FDA UDI
Zavation LLC·00842166108745·PLIF-C 9x32 Convex -9
Zavation
FDA UDI
Zavation LLC·00842166108776·PLIF-C 9x32 Convex -12
BOSTON EO (ENFLUFOCON B) CONTACT LENS FOR ORTHOKERATOLGY
FDA 510(k)
FDA Class 2
·Ophthalmic
ARACHNOPHLEBECTOMY NEEDLE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
VC10 PUMP, 115V
FDA Adverse Event
Malfunction
·GYRUS ACMI, INC.·Product code HHK·January 2, 2025
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 2, 2013
CONSTELLATION WITH LASER
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·March 4, 2011
GUIDANT 4.5 MM HEARTSTRING PROXIMAL SEAL
FDA Adverse Event
Malfunction
·GUIDANT CARDIAC SURGERY·Product code DXC·April 17, 2008
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
Spirit Plus Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
Spirit Select Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 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