13 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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XPEED ANYRIDGE INTERNAL IMPLANT SYSYEM
FDA 510(k)
FDA Class 2
·Dental
Embla
FDA UDI
S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD·07290013817037·
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319740248·Coller Forceps 6-1/4" (15.9cm), slightly curved...
R&D INNOVATION PEDICLE SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BDRV CANN SCW SS P/T DIA4.5X60 MM
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code HWC·March 7, 2017
BDRV CANN SCW SS P/T DIA4.5X52 MM
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code HWC·March 7, 2017
CCU,MODULAR,IMAGE1S 4U, CONNECT, INTL,CE
FDA Adverse Event
Malfunction
·KARL STORZ SE & CO. KG·Product code FET·January 30, 2025
CCU,MODULAR,IMAGE1S 4U, CONNECT, INTL,CE
FDA Adverse Event
Malfunction
·KARL STORZ SE & CO. KG·Product code FET·September 10, 2025
TRENDRIL ST
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code DTB·January 13, 2014
PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Death
·AV-TEMECULA-CT·Product code NIQ·May 31, 2013
UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code GKZ·June 25, 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