16 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IMMULITE RAPID TSH
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Nexxis OR
FDA UDI
Barco NV·05415334002425·MNA-120 ENC ANA CM + CBL 5M
Reprocessed Oscillating Sagittal Saw Blade, 18 x 5.5 x 0.56mm
FDA UDI
SURETEK MEDICAL·B390KM332121·
Brasseler USA
FDA UDI
Provision·B504OMKM332120·
SMALL BONE BLADES
FDA UDI
Peter Brasseler Holdings, LLC·00887919094258·KM33-212
Brasseler USA
FDA UDI
Provision·00810041064936·
NA
FDA UDI
STERILMED, INC.·10888551017107·SAW BLADE MICRO OSCILLATING 9 TEETH/CM STRYKER ...
Ophthalmic Spatula
FDA UDI
KATENA PRODUCTS, INC.·00841668103395·LABOR CYCLODIALYSIS SPATULA 0.5MM SHORT
LIFESTENT SDS BILIARY ENDOPROSTHESIS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ZELTIQ COOLSCULPTING SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ZELTIQ COOLCORE (6.3)
FDA Adverse Event
Injury
·ZELTIQ AESTHETICS INC.·Product code OOK·June 19, 2014
ARCHITECT I2000SR ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING, INC.·Product code JJE·June 16, 2009
PK DIEGO 2MM STR AGG TURBINATE
FDA Adverse Event
Other
·GYRUS AMCI, INC.·Product code ERL·January 15, 2013
SHUNT SENSOR SYS500
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·December 15, 2010
SINGLE TRIGGER ROTARY
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code HWE·July 14, 2014
EVOLUT FX DCS
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code NPT·August 8, 2025