50 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Opallis, Opallis Flow
FDA 510(k)
FDA Class 2
·Dental
Phantom Tibial Preparation
FDA UDI
ADLER ORTHO SPA·08056269043717·GENUS PANTHEON PHANTOM TIBIAL PREPARATION SZ.7
Ophthlamic Speculum
FDA UDI
KATENA PRODUCTS, INC.·10841668115159·BARRAQUER SPECULUM Disposable with Finger tabs ...
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613327466799·LE FORT I PLATE, 7MM ADVANCEMENT, LEFT
A-CIFT® SoloFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361021582·A-CIFT SoloFuse PEEK IBDF, Dual C Lock Lordotic...
SINGLE STEP BIOPSY DEVICE, SINGLE STEP SURGICAL HANDLE, SINGLE STEP DRIVER, SINGLE STEP HOLDERS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DIAMEDIX IS-TOXOPLASMA IGM CAPTURE TEST SYSTEM
FDA 510(k)
FDA Class 2
·Microbiology
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·October 27, 2020
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVAMEX·Product code IOR·October 27, 2014
VASOVIEW HEMOPRO 2
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·August 4, 2011
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 2, 2013
BD Q-SYTE CLOSED LUER ACCESS DEVICE
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FPA·November 6, 2023
BACT/ALERT® VIRTUO® INSTRUMENT
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC.·Product code MDB·November 26, 2018
BACT/ALERT® VIRTUO® INSTRUMENT
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC.·Product code MDB·November 26, 2018
BACT/ALERT® VIRTUO® INSTRUMENT
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC.·Product code MDB·November 26, 2018
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·November 28, 2023
Regard, Item Number: 880327005, Sterile, CV0758E - Open Heart A&B - OSU
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017
Regard, Item Number: 880342002, Sterile, GS0776B - Laparotomy - OSU
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017
VITROS Chemistry Products VANC Reagent, REF/Product Code 680 1709, Unique Identifier No. 10758750006731, Rx ONLY, IVD --- Ortho Clinical Diagnostics - USA -- Ortho-Clinical Diagnostics Pencoed, CF35 5PZ, UK ---- The VITROS VANC reagent is for ORTHO Clinical Diagnostics manufactured by Siemens. The VANC product has a maximum on-analyzer stability of < 7days. The on-analyzer stability of each VITROS VANC Reagent pack is determined by the system. Once the VANC reagent pack is loaded on the system, the on-analyzer stability time is continuously adjusted based upon both the amount of time the reagent pack is on the analyzer and the number of tests remaining in the pack. The method by which the on-analyzer stability of the VITROS VANC Reagent is determined is stated in the reagents Instructions for Use.
FDA Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics·May 3, 2017
Regard, Item Number: 800508001, Sterile, LD0586A - C Section - Jasper
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017