21 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Magicore System
FDA 510(k)
FDA Class 2
·Dental
DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169524309·TRIAL 2152520 MEDIUM 12 DEGREES 20MM
LEONE SPA
FDA UDI
LEONE SPA·08033707014386·CALIBRA 1ST MOL BANDS W/G8325-02 n.UR 20
Ophthalmic Forceps
FDA UDI
KATENA PRODUCTS, INC.·00841668106310·CASTROVIEJO FORCEPS 0.5MM
Trial Liners (20 degree hooded)
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215038731·
OrthoMedFlex
FDA UDI
ORTHOMEDFLEX LLC·M7161121525200·Trial Liner 20° 32/48-50 (B)
BD NEXIVA CLOSED IV CATHETER SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
RAPID FORSURE ONE STEP MULTIPLE DRUG (UP TO 6) SCREEN TEST DEVICE FOR AMPHETAMINE, METHAMPHETAMINE, BENZOYLECGONINE, THC
FDA 510(k)
FDA Class 2
·Clinical Toxicology
VIRTUOSO DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·June 7, 2013
PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE
FDA Adverse Event
Malfunction
·MEDELA, INC.·Product code HGX·October 6, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 27, 2011
BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·Product code FOZ·June 25, 2021
ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET
FDA Adverse Event
Injury
·COOK INC·Product code FGE·April 25, 2019
ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET
FDA Adverse Event
Injury
·COOK INC·Product code FGE·January 4, 2019
ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET
FDA Adverse Event
Injury
·COOK INC·Product code FGE·February 18, 2019
BD INTEGRA
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code MEG·November 17, 2023
ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FGE·July 26, 2019
BIOMET StageOne Hip Cement Spacer Mold with Insert, 60 MM, Silicone, Sterile, Item 431184.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
Precise Treatment Table. To be used as part of radiation therapy treatment process.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 17, 2013