12 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Bonvadis Topical Cream
FDA 510(k)
FDA Unclassified
·Unknown
Bernafon
FDA UDI
Bernafon AG·05711584114544·CO3 B 105, 2.4G NFM SABE/MSIL CAPTO 3 GPL
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450851432·
REMSTAR AUTO CPAP SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
TRANSRADIAL ARTERY ACCESS DEVICES
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 23, 2024
CSF-LUMBOPERITONEAL CATHETER SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC NEUROSURGERY·Product code JXG·August 11, 2011
SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) MEMBRANE
FDA Adverse Event
Injury
·GENZYME SURGERY (SEPRAFILM/PACK)·Product code MCN·October 27, 2008
INSIGNIA
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·July 9, 2013
BD BBL CULTURE SWAB PLUS MINI CHIP
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code LIO·November 2, 2021
18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer 10041227 & 10789400 S1000 10441701 S2000 10041461 S2000 (Refurb) - 10440017 S3000 10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017
The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.
FDA Enforcement
Class II
·Ongoing·Abbott Medical·January 1, 2025