14 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Hawkeye Control Unit with Eyas Endoscope
FDA 510(k)
FDA Class 2
·Orthopedic
SMALL BONE BLADES
FDA UDI
Peter Brasseler Holdings, LLC·00887919094227·KM33-115
Brasseler USA
FDA UDI
Provision·00810041064905·
Brasseler USA
FDA UDI
Provision·B504OMKM331150·
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113868·ROBINS ANTERIOR CHAMBER CANNULA, 30GA
Reprocessed Oscillating/Sagittal Saw Blade, Thick, 30 x 7 x 0.51mm
FDA UDI
SURETEK MEDICAL·B390KM331151·
NA
FDA UDI
STERILMED, INC.·10888551017077·SAW BLADE MICRO OSCILLATING 12 TEETH/CM STRYKER...
ORTHODEK
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACK
FDA 510(k)
FDA Class 2
·Ophthalmic
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·November 6, 2014
U BY KOTEX CLICK TAMPONS
FDA Adverse Event
Malfunction
·AVENT SA DE R.L. DE C.V.·Product code HEB·July 21, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 18, 2013
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