15 results
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26ms
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Sources: EU EUDAMED, US FDA
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