14 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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TRANSIT INFUSION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
SIC invent Dental Implant Systems
FDA UDI
SIC invent AG·ESIC9362601·SIC Standard Abutment "Safe on Four" Ø 3.3 mm, ...
SeaSpine Spacer System - Redondo™
FDA UDI
Seaspine Orthopedics Corporation·10889981045456·Redondo Trial 34mm x 24mm x 10mm, 8 Deg
FERNO-WASHINGTON AMBULANCE COT, 93ES SQUAD-MATE
FDA 510(k)
FDA Class 2
·General Hospital
ACOUSTIC ANALYZER AA30
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
VGXP XP E1 TIB BRG RM 9X71
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBH·February 19, 2018
VGXP XP E1 TIB BRG RL 10X71
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBH·February 19, 2018
VNGD XP INLK PRI TIB TRAY 75MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBH·February 19, 2018
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·January 30, 2013
ALPHAXCELL
FDA Adverse Event
Injury
·ARJOHUNTLEIGH·Product code FNM·December 15, 2010
RECAP PF FMRL HD RESURF 46MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KXA·July 15, 2014
Vanguard XP Tibial Tray 75 mm Item # 195251
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019
VGXP INTLK FMRL RT 60
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBH·February 19, 2018
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024