14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BURN JEL PLUS
FDA 510(k)
FDA Unclassified
·Unknown
Premier Elevator
FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·00348783004229·ELEVATOR HEIDBRINK 13-14
SCANLAN® Needle Holders
FDA UDI
SCANLAN INTERNATIONAL INC·00846159022797·Puskas™ Jacobson Micro Needle Holder
APNOESCREEN PRO, ALPHA SCREEN PRO
FDA 510(k)
FDA Class 2
·Anesthesiology
ENDOCARE PERCUTANEOUS ACCESS SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RESTORE
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 29, 2015
BD A-LINE¿
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·July 10, 2024
BD A-LINE¿
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·November 27, 2024
UNKNOWN DEPUY POLY ACETABULAR LINER
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code KWA·March 14, 2013
OT PING METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·March 1, 2011
RADIO FREQUENCY ABLATION
FDA Adverse Event
Product code GEI·February 27, 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
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024