15 results · 26ms · Sources: EU EUDAMED, US FDA

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ASPIRE COVERED STENT AND DELIVERY CATHETER

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Premier Curettes

FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·00348783007831·CURETTE MOLT 5L

SCANLAN® Needle Holders

FDA UDI
SCANLAN INTERNATIONAL INC·00846159008722·Jacobson Micro Needle Holder Round Handle

SCANLAN® Titanium Needle Holder

FDA UDI
SCANLAN INTERNATIONAL INC·00846159035193·Jacobson Micro Needle Holder, Round Handle, wit...

CEMENT IT! UNIVERSAL C&B

FDA 510(k)
FDA Class 2 ·Dental

NYLON, NONABSORBABLE SURGICAL SUTURES USP

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·January 5, 2026

GMK-REVISION FIXED TIBIAL INSERT SC SIZE 5/17MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·February 27, 2024

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 14, 2013

GREENLIGHT MOXY FIBER OPTIC

FDA Adverse Event
Malfunction ·AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)·Product code GEX·August 12, 2014

FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·February 28, 2011

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·January 15, 2026

bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Enforcement
Class II ·Ongoing·B-K Medical A/S·November 12, 2025

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

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