15 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ALGS2 Ag Alginate Wound Dressing Rx; ALGS2 Ag Alginate Wound Dressing OTC; ALGS2S Re-enforced Ag Alginate Wound Dressing Rx; ALGS2S Re-enforced Ag Alginate Wound Dressing OTC
FDA 510(k)
FDA Unclassified
·Unknown
Reprocessed Oscillating/Sagittal Saw Blade, Thick, 25 x 9 x 0.51mm
FDA UDI
SURETEK MEDICAL·B390KM331111·
SMALL BONE BLADES
FDA UDI
Peter Brasseler Holdings, LLC·00887919094203·KM33-111
Brasseler USA
FDA UDI
Provision·00810041064882·
Brasseler USA
FDA UDI
Provision·B504OMKM331110·
NA
FDA UDI
STERILMED, INC.·10888551017053·SAW BLADE MICRO OSCILLATING 12 TEETH/CM STRYKER...
KINGTECH DIGITAL THERMOMETER
FDA 510(k)
FDA Class 2
·General Hospital
Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System
FDA 510(k)
FDA Class 2
·Cardiovascular
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 2, 2011
RESERVOIR 1.8ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·November 6, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·July 18, 2013
TECNIS IOL
FDA Adverse Event
Injury
·AMO PUERTO RICO MFG. INC.·Product code MJP·December 13, 2024
Azurion 7 B12; System Code: (1)722067, (2)722225, (3)722235;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
CODMAN Disposable Perforator, 14mm. Cranial perforator.
FDA Enforcement
Class I
·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025