19 results · 21ms · Sources: EU EUDAMED, 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