13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Arm Blood Pressure Monitor
FDA 510(k)
FDA Class 2
·Cardiovascular
Maestro™ Total Wrist
FDA UDI
Biomet Orthopedics, LLC·00887868240065·
MAESTRO TOTAL WRIST
FDA UDI
Biomet Orthopedics, LLC·00880304555228·
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197453141·CCR Titanium Medial Blade
24x35m...
OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AMEDA PLATINUM BREAST PUMP
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MAESTRO MEDIUM FIXED DURAGUARD
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code ERL·October 17, 2014
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - COSTA RICA (HEREDIA)·Product code MCX·June 20, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011
ENNOVATE POLYAX.SCREW 6.5X45MM FENESTR.
FDA Adverse Event
Injury
·AESCULAP AG·Product code NKB·December 21, 2018
ENNOVATE POLYAX.SCREW 7.5X40MM FENESTR.
FDA Adverse Event
Injury
·AESCULAP AG·Product code NKB·December 21, 2018
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 9, 2026
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 10, 2026