15 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR
FDA 510(k)
FDA Class 2
·Radiology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517570451·CoRoent Ant TLIF Ti, 13x12x34mm 4°
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113356·CLEAR CORNEA KNIFE 2.8MM (BX/5)
Ophthalmic Spatula
FDA UDI
KATENA PRODUCTS, INC.·00841668102503·MILDER PHACO SPATULA DOUBLE ENDED, RIGHT
NOBELACTIVE TIULTRA NP 3.5X13MM
FDA Adverse Event
Injury
·NOBEL BIOCARE AB·Product code DZE·May 31, 2021
NOBELACTIVE TIULTRA NP 3.5X13MM
FDA Adverse Event
Injury
·NOBEL BIOCARE AB·Product code DZE·May 31, 2021
E-Z CHECK OZONE TEST STRIPS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM MODEL 10-330
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
REFLEXION STEERABLE CATHETER
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC.·Product code DRF·October 29, 2008
PINNACLE MTL INS NEUT40IDX56OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910 ·Product code KWA·August 18, 2011
ANTI-HUMAN GLOBULIN ANTI-IGG
FDA Adverse Event
Malfunction
·BIOTEST AG·Product code KSZ·December 21, 2012
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 9, 2026
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 10, 2026
BD VERITOR¿ PLUS ANALYZER
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code PSZ·March 7, 2025
Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025