21 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RIGHTEST CONTROL SOLUTION
FDA 510(k)
FDA Class 1
·Clinical Chemistry
N/A
FDA UDI
MEDTRONIC XOMED, INC.·00763000035105·PROSTHESIS 1133003 CUP PISTON .6X4.0 SST
Robinson
FDA UDI
MEDTRONIC XOMED, INC.·00681490034395·PROSTHESIS 1133003 CUP PISTON .6X4.0 SST
Contours™ Finishing & Polishing Discs Trial Kit
FDA UDI
DEN-MAT HOLDINGS, LLC·00359883006174·Aluminum oxide dental finishing and polishing a...
SUCTION COAGULATOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AESCULAP- MEITHKE PROGAV PROGRAMMABLE SHUNT SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
LO-PRO LOCK SCRW,SS 2.7X 14MM
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code HWC·August 12, 2025
LO-PRO LOCK SCRW,SS 2.7X 14MM
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code HWC·August 12, 2025
LOW PROFILE LOCKING SCREW, 2.7 X 14 MM
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code HWC·May 31, 2024
CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·June 17, 2011
GOBED+
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 29, 2013
MOSAIC AORTIC BIOPROSTHETIC HEART VALVE
FDA Adverse Event
Death
·MEDTRONIC HEART VALVES, INC.·Product code LWR·August 21, 2008
ROBINSON STAPES PROSTHESIS 0.6 X 4.0MM W/1MM
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC.·Product code ETB·July 30, 2002
RAD AIMING ARM/FRN GREATER TROCHANTER
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HSB·October 13, 2021
Catalog 314-13-33, Equinoxe Cage Glenoid, Posterior Augment, Right, Medium
FDA Enforcement
Class II
·Terminated·Exactech, Inc.·November 25, 2020
LO-PRO LOCK SCRW,SS 2.7X 14MM
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code HWC·August 12, 2025
UNK
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HWC·May 27, 2025
UNK
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HWC·May 27, 2025
VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit
FDA Enforcement
Class II
·Terminated·VGI Medical, LLC·June 13, 2018
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024