34 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AnyOne Onestage Implant System
FDA 510(k)
FDA Class 2
·Dental
BACT/ALERT® 3D RIGHT INCUBATION MODULE
FDA UDI
BIOMERIEUX , INC.·03573026049591·The BacT/ALERT 3D Right Incubator Module has fo...
Dilator, Vascular, acc. Garrett 35cm 0.5mm
FDA UDI
Geister Medizintechnik GmbH·04057034047507·Dilator, Vascular, acc. Garrett
35cm 0...
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319744529·Nasal Retractor 4" (10.1cm), 9mm x 45mm blade
TriplePlay
FDA UDI
DYMEDIX DIAGNOSTICS, INC.·00817377020988·Interface Cable, Cadwell, Disposable Effort Bel...
Resolve® Ceramic
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K210151111·Resolve® Ceramic R018 UL 5-5 CS BC HK
Resolve® Ceramic
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K210151811·Resolve® Ceramic M018 UL 5-5 CS BC HK
Resolve® Ceramic
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K210151121·Resolve® Ceramic R018 UL 5-5 CS HK/MBT 4-5
ALPHAPOINT IMAGING SOFTWARE
FDA 510(k)
FDA Class 2
·Radiology
3MP Monochrome Digital Mammography LCD Monitor MS-S300
FDA 510(k)
FDA Class 2
·Radiology
BD LUER-LOK¿ TIP DISPOSABLE SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·December 14, 2021
RAD-97 PULSE CO-OXIMETER
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code MWI·November 7, 2023
RAD-97 PULSE CO-OXIMETER
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code MWI·December 11, 2023
RAD-97 PULSE CO-OXIMETER
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code MWI·December 22, 2023
RAD-97 PULSE CO-OXIMETER
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code MWI·October 30, 2023
RAD-97 PULSE CO-OXIMETER
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code MWI·October 30, 2023
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·ANIMAS CORP·Product code LZG·October 22, 2008
FUSION OMNI-TOME
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL, INC.·Product code KNS·August 4, 2011
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·July 8, 2013
RAD-97 PULSE CO-OXIMETER
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code MWI·October 11, 2023