19 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ClariVein IC
FDA 510(k)
FDA Class 2
·Cardiovascular
LEONE SPA
FDA UDI
LEONE SPA·08033707014942·CALIBRA 1ST MOL BANDS W/G8325-03 n.UL 2
Symmetry Jacobson
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482055762·Symmetry® Forceps, Jacobson Mosquito, Curved, M...
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100288·SAUER PREMATURE INFANT SPECULUM 2MM
GUTTA PERCHA POINTS
FDA UDI
DiaDent Group International·08806383507516·Gutta Percha Points is used to root canal filin...
HNM Medical
FDA UDI
HNM STAINLESS, LLC.·00842962111314·MICRO JACOBSON FORCEPS, 4", CVD
NEWPORT E360 VENTILATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001
FDA 510(k)
FDA Class 2
·Immunology
ESON 2 NASAL MASK
FDA Adverse Event
Injury
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZD·August 14, 2019
GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 2+ L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·May 26, 2021
A) Presource PBDS, Lap Chole, Kit, Clean Up; B) Presource PBDS, Greenwood LeFlore Hosp, Lap Chole, Kit
FDA Enforcement
Class I
·Terminated·Cardinal Health, Medical Products & Services·May 15, 2013
QUADRA ASSURA CRT-D, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·October 8, 2014
CAPSURE Z NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 8, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 21, 2011
PATIENT INFORMATION CENTER IX
FDA Adverse Event
Death
·PHILIPS MEDICAL SYSTEMS·Product code MHX·March 15, 2023
PATIENT INFORMATION CENTER IX
FDA Adverse Event
Death
·PHILIPS MEDICAL SYSTEMS·Product code MHX·November 9, 2023
BD BBL Sensi Disc Moxifloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231758¿
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·February 14, 2024
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021