14 results
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18ms
·
Sources: EU EUDAMED, US FDA
KEISEI SURGICAL BLADES (STERILE & NON-STERILE)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Legacy™3 Implant
FDA UDI
IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307102403·3.2mmD x 11.5mmL, 3.0mmD Platform
Symmetry Metzenbaum
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482128060·Symmetry® Scissors, Metzenbaum, Straight, Serra...
Shoreline™ ACS
FDA UDI
Seaspine Orthopedics Corporation·10889981143947·Trial Rasp, 18x15x11mm, 7 Deg Lordosis
PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERT
FDA 510(k)
FDA Class 2
·Orthopedic
MAGNETOM Sempra with syngo MR E11S
FDA 510(k)
FDA Class 2
·Radiology
5.5MM TI CANCELLOUS LOCKING SCREW 39MM THRD LENGTH
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code KWQ·September 30, 2019
PROTECTA DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·June 10, 2014
SPRINT QUATTRO SECURE
FDA Adverse Event
MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 9, 2010
PROSTHESIS 1150001 UNIVERSAL TITANIUM CA
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code ETB·December 10, 2012
Various ob/gyn packs
FDA Enforcement
Class II
·Ongoing·American Contract Systems, Inc.·September 14, 2022
Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 7, 2024
Various Laparoscopy Packs
FDA Enforcement
Class II
·Ongoing·American Contract Systems, Inc.·September 14, 2022
Various convenience packs
FDA Enforcement
Class II
·Ongoing·American Contract Systems, Inc.·September 14, 2022