21 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HARDYDISK CEFOPERAZONE, 75 MCG
FDA 510(k)
FDA Class 2
·Microbiology
Implant Prosthetics
FDA UDI
Preat Corporation·00842092133088·Straumann® BL-compatible NC/RC Muti-Unit Titani...
Endo Carry-On Procedure Kit
FDA UDI
MEDIVATORS INC.·40677964013650·Endo Carry-On Procedure Kit includes Essential ...
Implant Prosthetics
FDA UDI
Preat Corporation·00842092116838·Straumann® BL NC/RC-compatible Multi-Unit Titan...
artVeneer life
FDA UDI
Merz Dental GmbH·D7092001489·artVeneer life lower anteriors, UBIL, D3
POLYMACON
FDA 510(k)
FDA Class 2
·Ophthalmic
ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST
FDA 510(k)
FDA Class 2
·Immunology
BD SYRINGE 3ML LL BNS
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·February 7, 2025
LIGACLIP MCA
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code GDO·February 25, 2013
ENGEN LABORATORY AUTOMATION SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code JJE·February 25, 2011
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIQ·February 19, 2008
BD SYRINGE 5ML LL BNS
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·February 7, 2025
BD SYRINGE 1ML LL BNS
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·February 7, 2025
BAXJECT II HI-FLOW NEEDLESS TRANSFER DEVICE
FDA Adverse Event
Malfunction
·TAKEDA PHARMACEUTICALS U.S.A., INC.·Product code LHI·May 4, 2026
SURESCAN
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·November 20, 2017
Li-Ion battery used in the Oxus Portable Oxygen Concentrator (POC), RS-00400. Also branded as Reliability Plus byDrive. The Portable Oxygen Concentrator is intended to deliver concentrated oxygen for adult patients with chronic pulmonary diseases.
FDA Enforcement
Class II
·Terminated·Oxus America, Inc.·February 13, 2013
Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ14; Product is manufactured and distributed by Sunrise Medical (US) LLC., Fresno, CA. Used by a person to move from one place to another while sitting.
FDA Enforcement
Class II
·Terminated·Sunrise Medical (US) LLC·December 11, 2013
Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·March 27, 2013
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; 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