17 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ELEKTA NEUROMAG WITH MAXWELL FILTER WITH INTERNAL ACTIVE SHIELDING
FDA 510(k)
FDA Class 2
·Neurology
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16740814300·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1674081430060·
CoRoent
FDA UDI
Nuvasive, Inc.·00887517284273·CoRoent® LO Ti, 14x10x30mm 5°
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X0814350·8mm H x 14mm W x 30mm L x 0 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X0814300·8mm H x 14mm W x 30mm L x 0 degrees ALIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587L081430120·8mm H x 14mm W x 30mm L XLIF Trial 12 degree Lo...
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X08143080·8mm H x 14mm W x 30mm L x 8 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X081430120·8mm H x 14mm W x 30mm L x 12 degrees XLIF
RESPIRTECH PRO-O2C, MODEL 2200 AND RESPIRTECH PRO, MODEL 2000
FDA 510(k)
FDA Class 2
·Anesthesiology
ACTIWARE-PLMS
FDA 510(k)
FDA Class 2
·Neurology
530G INSULIN PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OZO·September 11, 2014
SOLETRA
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·April 22, 2011
CANDELA V BEAM LASER
FDA Adverse Event
Injury
·Product code GEX·July 24, 2008
Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025