19 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Aplio 500/400/300 Diagnostic Ultrasound System V6.0
FDA 510(k)
FDA Class 2
·Radiology
ProLift Trial
FDA UDI
Life Spine, Inc.·00190837087890·
HNM SPORTS MEDICINE
FDA UDI
HNM STAINLESS, LLC.·00842962101797·ETHOS PRO SMALL JOINT ANCHOR, PEEK, 2.9mm x 6mm...
APEX MODULE HIP SYSTEM BIOLOX DELTA FEMORAL HEAD
FDA 510(k)
FDA Class 2
·Orthopedic
MICROPLEX COIL SYSTEM-VECTOR MODEL 030606XXX-V, 030610XXX-V, 30615XXX-V, 061020XXX-V, 061030XXX-V, 101530XXX-V, 101540XX
FDA 510(k)
FDA Class 2
·Neurology
HNM SPORTS MEDICINE
FDA UDI
HNM STAINLESS, LLC.·00842962104002·ETHOS PRO SMALL JOINT ANCHOR, PEEK, 2.9mm x 6mm...
WARMER DRAPE
FDA Adverse Event
Malfunction
·MICROTEK DOMINICANA, S.A.·Product code LHC·February 6, 2016
WARMER DRAPE
FDA Adverse Event
Malfunction
·MICROTEK DOMINICANA, S.A.·Product code LHC·January 6, 2016
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 8, 2014
PLUM XLD 110V L.A.
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·May 30, 2013
TRANSTAR
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FPO·June 8, 2011
BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET
FDA Adverse Event
Injury
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·September 15, 2022
UNIVERSA SOFT URETERAL STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·January 29, 2019
UNIVERSA SOFT URETERAL STENT SET
FDA Adverse Event
Malfunction
·COOK UROLOGICAL INC·Product code FAD·May 13, 2016
UNIVERSA SOFT URETERAL STENT SET
FDA Adverse Event
Injury
·COOK INC·Product code FAD·September 8, 2016
UNIVERSA SOFT URETERAL STENT SET
FDA Adverse Event
Injury
·COOK UROLOGICAL INC·Product code FAD·May 13, 2016
UNKNOWN
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·July 23, 2019
Medical Linear Accelerator
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·September 14, 2016
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