14 results
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18ms
·
Sources: EU EUDAMED, US FDA
INCOS 50 MASS SPECTROMETER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Archon
FDA UDI
Nuvasive, Inc.·00887517304100·Archon Screw, 4.0x18mm S.T. Var Recon
Snowden-Pencer
FDA UDI
CAREFUSION 2200, INC·10885403151170·Snowden-Pencer TISSUE FORCEPS 30.5CM (12"), FUL...
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575258918·Tibial Component, All-Poly PS
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575258925·Tibial Component, All-Poly PS
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575258901·Tibial Component, All-Poly PS
Reliant(TM) Multistage Dilatation Balloon Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPS, BIOSET, SIOSET IC, RTI ALLOGRAFT PAST
FDA 510(k)
FDA Class 2
·Dental
HEARTMATE II LVAS
FDA Adverse Event
Malfunction
·THORATEC CORP·Product code DSQ·April 8, 2014
SYNVISC ONE (HYLAN G-F 20) INJECTION 6/ML
FDA Adverse Event
Other
·GENZYME BIOSURGERY (RIDGEFIELD)·Product code MOZ·October 8, 2010
RESTORE ULTRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·December 19, 2012
a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100-03M, CS-10100-03M. b. Segmental Stem, Cemented, Straight, 120MM, 1 EACH. Model Numbers: CS-11120-03M, CS-13120-03M, CS-15120-03M, CS-17120-03M. Component. of ELEOS LIMB SALVAGE SYSTEM
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025
SPRYSTEP VECTOR, Custom made device dynamic ankle-foot orthosis (AFO) , Reference numbers: 17V1030, 17V2030, 17V1031, 17V2031, 17V1032, 17V2032, 17V1033, 17V2033, 17V1035, 17V2035, 17V1036, 17V2036, 17V1037, 17V2037
FDA Enforcement
Class II
·Completed·Townsend Design·January 17, 2024
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020