16 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PE.R.I. II KNEE FRACTURE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CAMLOG
FDA UDI
Preat Corporation·00842092102848·CAMLOG® Screw-Line-compatible 3.3mm Non-Engagin...
Alpha-Tec Systems
FDA UDI
Alpha-TEC Systems, Inc.·00816085020488·Gram Stain Control Slides With 3 Patient Wells
SCANLAN® Needle Holders
FDA UDI
SCANLAN INTERNATIONAL INC·00846159003062·Jacobson Micro Needle Holder Flat Handle
FacetFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361020035·Facet Screw Assy, ø5.5 x 35mm, Short Outer Teet...
OPTI-FREE SUPRACLENS DAILY POTEIN REMOVER / RGP MULTI-PURPOSE DISINFECTING SOLUTION ID 100136
FDA 510(k)
FDA Class 2
·Ophthalmic
INSYTE CATHETER, INSYTE AUTOGUARD CATHETER
FDA 510(k)
FDA Class 2
·General Hospital
GMK-SPHERE PATELLA RESURFACING SIZE 3
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·June 2, 2021
LIGHT ADJUSTABLE LENS (LAL)
FDA Adverse Event
Injury
·RXSIGHT, INC.·Product code PZK·April 21, 2022
BD ANGIOCATH¿ PLUS
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·January 26, 2018
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 14, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·February 28, 2011
NEUROFORM 3 MICRODELIVERY STENT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code NJE·February 21, 2008
smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024
UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly
FDA Enforcement
Class II
·Ongoing·Covidien·August 28, 2024