50 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FUJIFILM Distal Cap Models 33-40
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
3 Port Manifold - Left/Off/Open Body - 500 PSI
FDA UDI
ARGON MEDICAL DEVICES, INC.·00886333207046·3 Port Manifold - Left/Off/Open Body - 500 PSI
Edge™ Diamond TS012-6M Tapered Shoulder
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172003414·Diamond dental bur, reusable
APEX POINTER+; MEASRUING CABLE, HOOK, LIP CLIP, TOUCH PROBE (ACCESSORIES)
FDA 510(k)
FDA Unclassified
·Unknown
BIOMERIX VENTRAL HERNIA REPAIR MESH, MODEL SM3-TAB
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY
FDA Adverse Event
Injury
·COOK INC·Product code JOH·January 24, 2022
VSP SYSTEM
FDA Adverse Event
Injury
·3D SYSTEMS·Product code DZJ·December 18, 2020
INRATIO
FDA Adverse Event
Malfunction
·HEMOSENSE, INC.·Product code JPA·October 6, 2008
STORZ BARRETT NUCLEUS MANIPULATOR
FDA Adverse Event
Malfunction
·BAUSCH & LOMB, INC.·Product code KGE·June 25, 2013
PULSE GEN MODEL 102
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·July 22, 2011
REF 101-05-40***NOVATION MODULAR DRILL BIT LENGTH: 40mm, DIAMETER 3.2mm***Use with 40mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique for hemi & total hip arthroplasty. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.
FDA Enforcement
Class II
·Terminated·Exactech, Inc.·September 19, 2012
BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY
FDA Adverse Event
Injury
·COOK INC·Product code JOH·January 24, 2022
BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY
FDA Adverse Event
Malfunction
·COOK INC·Product code JOH·May 11, 2022
BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY
FDA Adverse Event
Malfunction
·COOK INC·Product code JOH·July 17, 2023
BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY
FDA Adverse Event
Malfunction
·COOK INC·Product code JOH·July 17, 2023
BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY
FDA Adverse Event
Malfunction
·COOK INC·Product code JOH·May 28, 2024
BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code JOH·June 21, 2024
BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY
FDA Adverse Event
Malfunction
·COOK INC·Product code JOH·January 15, 2025
BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY
FDA Adverse Event
Malfunction
·COOK INC·Product code JOH·January 14, 2022
BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET
FDA Adverse Event
Death
·COOK INC·Product code JOH·March 14, 2022