28 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Amsco Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200),Evolution Automated Loading and Unloading System (ALUS); Amsco EvolutionMedium Steam Sterilizer (Models HC-600 and HC-1500),Evolution Automated Loading and Unloading System (ALUS); Amsco EvolutionMedium Steam Sterilizer (Models HC-800 and HC-1000),Evolution Automated Loading and Unloading System (ALUS)
FDA 510(k)
FDA Class 2
·General Hospital
6PW - CPRotector® ONE Deluxe - Poly White
FDA UDI
Certified Safety Manufacturing, Inc.·00766588030012·6PW - CPRotector® ONE Deluxe - Poly White
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112540·BARRON VACUUM TREPHINE 8.75MM
Responsive Respiratory, Inc.
FDA UDI
RESPONSIVE RESPIRATORY, INC.·00851440007292·Oxygen Regulator, 15 LPM CGA 540 w/ Barb
XLP - Toyota - Black - XLPouch
FDA UDI
Certified Safety Manufacturing, Inc.·00766588030111·XLP - Toyota - Black - XLPouch
SYNTHES USS (10.0MM SIDE OPENING SCREWS)
FDA 510(k)
FDA Class 2
·Orthopedic
KONICA DIRECT DIGITIZER REGIUS, MODEL 170
FDA 510(k)
FDA Class 2
·Radiology
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code QJR·September 18, 2020
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code QJR·September 11, 2020
BD MAX SYSTEM, BD MAX INSTRUMENT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code OOI·September 3, 2020
SMS STEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·November 4, 2025
SMS STEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·January 8, 2026
SMS STEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·January 29, 2026
CAPSUREFIX
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011
9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·September 18, 2014
XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code FGE·July 2, 2013
BALL HEADS: MECTACER 01.29.211 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE XL
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·May 26, 2023
SMS STEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·November 18, 2025
CUP: MPACT 01.32.148DH ACETABULAR SHELL Ø48 TWO-HOLES
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·October 28, 2022
MECTACER BIOLOX DELTA FEMORAL BALL HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·February 12, 2025