19 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology)
FDA 510(k)
FDA Class 2
·Dental
Unity Total Knee System
FDA UDI
CORIN LTD·05056139233098·Unity ASC Size 5 Tibial Template Trial
DVX5.5 SPINE SYSTEM
FDA UDI
BK MEDITECH CO.,LTD.·08809228126668·Cross-Link, 55mm
MEGA5.5 SPINE SYSTEM
FDA UDI
BK MEDITECH CO.,LTD.·08809228126101·Cross-Link, 55mm
Symmetry Surgical
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482001417·Symmetry® Curette, Spinal, Angled, Size 2, 8 in...
BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·February 11, 2020
Regatta Lateral System
FDA UDI
Seaspine Orthopedics Corporation·10889981162153·Lateral Implant, 23mm x 10mm x 55mm, 15 Deg
Regatta Lateral System
FDA UDI
Seaspine Orthopedics Corporation·10889981158866·Lateral Implant, 23mm x 10mm x 55mm, 10 Deg
ITI DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
Microcurrent device (Model: HBR2-1)
FDA 510(k)
FDA Class 2
·Neurology
BALANCE (TM)
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K31055241·BALANCE (TM) Base Rx 022 UL/5-5 CS-BC HK
BALANCE (TM)
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K31055141·BALANCE (TM) Base Rx 018 UL/5-5 CS-BC HK
Vu aPod™ - L
FDA UDI
Seaspine Orthopedics Corporation·10889981046668·LATERAL IMPLANT, WIDE, LORDOTIC, 10mm X 23mm X ...
STERRAD 100S STERILIZER
FDA Adverse Event
Malfunction
·ADVANCED STERILIZATION PRODUCTS·Product code MLR·October 30, 2008
AC POWER MODULE
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·July 20, 2011
PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·July 12, 2013
CD HORIZON LEGACY 5.5
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code LXH·September 16, 2024
Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23055 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: No
FDA Enforcement
Class II
·Ongoing·CooperSurgical, Inc.·December 25, 2024
Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23055 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: No
FDA Recall
Open, Classified
·CooperSurgical, Inc.·Product code PUB·November 15, 2024