12 results
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25ms
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Sources: EU EUDAMED, US FDA
WCCS 800 WALLACH CARDIAC CRYOSURGICAL SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Archon
FDA UDI
Nuvasive, Inc.·00887517303783·Archon Screw, 4.0x16mm S.T. Var Recon
Snowden-Pencer
FDA UDI
CAREFUSION 2200, INC·10885403151156·Snowden-Pencer TISSUE FORCEPS 30.5CM (12"), STR...
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575258840·Tibial Component, All-Poly PS
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575258864·Tibial Component, All-Poly PS
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575258857·Tibial Component, All-Poly PS
PANTRIDGE MK III DEFIBRILLATOR/MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System
FDA 510(k)
FDA Class 2
·Cardiovascular
AUTOMATED PD SET W/CASSETTE4 PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·October 22, 2010
CURRENT PLUS DR, DF4 CONNECTOR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC. CRMD·Product code LWS·January 13, 2014
ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NIQ·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