13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SIGNA Creator, SIGNA Explorer
FDA 510(k)
FDA Class 2
·Radiology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526550209·GENUMEDI PT KNEE SUP SILVER R EW V
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814176·GENUMEDI PT SILVER R I
CANDELA FAMILY OF PULSED DYE LASER SYSTEMS, MODELS VBEAM, CBEAM, SPTL-1B
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DUOCENTRIC REVERSED
FDA 510(k)
FDA Class 2
·Orthopedic
1823260-2017-00374
FDA Adverse Event
Malfunction
·February 20, 2017
COBAS E 411 IMMUNOASSAY ANALYZER
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·April 20, 2017
UNKNOWN KNEE
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·October 15, 2014
HEARTWARE® VENTRICULAR ASSIST SYSTEM
FDA Adverse Event
HEARTWARE, INC·Product code DSQ·June 3, 2013
VITAL SIGNS MONITOR 300 SERIES
FDA Adverse Event
Malfunction
·WELCH ALLYN PROTOCOL, INC.·Product code MWI·September 26, 2014
CELL-DYN 3200 CS 110V ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·June 28, 2011
Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.
FDA Enforcement
Class II
·Terminated·Ecolab Inc·September 30, 2015
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021