11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DOLPHIX EXTERNAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
HHM
FDA UDI
Oticon A/S·05707131258571·H150, RITE 312 WL STG HHM
DERF NEEDLE HOLDER
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896075924·DERF NEEDLE HOLDER TUNGSTEN CARBIDE DUST TIP DO...
Ophthalmic Spatula
FDA UDI
KATENA PRODUCTS, INC.·00841668102633·LIEBERMAN DOUBLE ENDED MICROFINGER, LEFT
ZOLL M SERIES NIBP OPTION
FDA 510(k)
FDA Class 2
·Cardiovascular
SPSMEDICAL EMPLUS 270 F STEAM EMULATOR MODEL EMP-104, EMP-1004
FDA 510(k)
FDA Class 2
·General Hospital
OT VERIO2 METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 8, 2016
LTV
FDA Adverse Event
Malfunction
·CAREFUSION 203, INC·Product code CBK·May 1, 2013
COPE GASTROINTESTINAL SUTURE ANCHOR SET
FDA Adverse Event
Malfunction
·COOK, INC.·Product code FGE·June 14, 2011
ELECTRIC MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL QUEBEC LP·Product code FNL·August 22, 2008
Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare Inc·May 13, 2015