13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Case - classic flat pack (CL-02); Phoenix Contact Lens Case - sunglass shape flat pack (CL-03)
FDA 510(k)
FDA Class 2
·Ophthalmic
Intrigue
FDA UDI
LANCER ORTHODONTICS, INC.·00817573021154·INTRG WHISP ROTH CUS 0T+11A 022 UR
Brisbane ALIF Cage
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215018191·
CLICKFINE AUTOPROTECT PEN NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
CODMAN BACTISEAL BARIUM STRIPED CATHETERS
FDA 510(k)
FDA Class 2
·Neurology
MECTALIF ANT - LAG
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code OVD·April 12, 2024
RESOLUTION CLIP DEVICE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code MND·November 12, 2008
STYLE 110 SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN·Product code FTR·August 26, 2011
PINN MAR NEUT 32IDX54OD
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code LPH·July 17, 2013
SKINTACT
FDA Adverse Event
Injury
·LEONHARD LANG GMBH·Product code GEI·April 16, 2024
Azurion 5 M20; Catalog numbers: (1) 722228, (2) 722232 (OUS ONLY), (3) 722281 (OUS ONLY).
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
BIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 433165.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020