23 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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IMMULITE 2000 DHEA-SO4; THIRD GENERATION TSH AND INTACT PTH CALIBRATION VERIFICATION MATERIAL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
HHM
FDA UDI
Oticon A/S·05707131269034·H110, DESIGNRITE 10 WL CBE HHM
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017736·K-Wire, Double Ended, Trocar Point, Diameter Si...
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319720752·Gemini-Mixter Forceps 9" (22.5cm), delicate, fu...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197052276·Titan Halsted Mosquito Artery Forceps
straig...
Integra-Ti
FDA UDI
BICON, LLC·00813110020819·4.0 x 8.0mm Integra-Ti Implant - 2.5mm Well
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197052269·Titan Hartmann Artery Forceps
straig...
SYNTHES MEDIUM EXTERNAL FIXATION SYSTEM-MR SAFE
FDA 510(k)
FDA Class 2
·Orthopedic
ELECTROSURGICAL PENCIL WITH ELECTRODE, WP200
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 4, 2025
STAT DL 9.5 FR. 40 CC. IAB
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·September 16, 1998
STAT DL 9.5 FR. 40 CC. IAB
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·September 16, 1998
STAT DL 9.5 FR. 34 CC. IAB
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·July 23, 1998
STAT DL 9.5 FR. 40 CC. IAB
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·September 16, 1998
ENDURANT II
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·May 31, 2013
ENCORE BALLOON CATHETER INFLATION DEVICE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code MAV·June 27, 2011
PUMP MMT-522NAS PRDGM INS V2.2 SK EN
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·August 29, 2008
STAT DL 9.5 FR. 40 CC. IAB
FDA Adverse Event
Injury
·DATASCOPE CORP.·Product code DSP·August 18, 1998
ProScreen 6 Panel Cup w/Adult (AU), Item No. PSCupA-6MBAU
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025