13 results · 20ms · Sources: EU EUDAMED, 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