15 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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DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USE
FDA 510(k)
FDA Class 2
·Dental
Clement Clarke International
FDA UDI
CLEMENT CLARKE INTERNATIONAL LIMITED·05023323028860·ONE WAY VALVE INSP (500)
K-Systems
FDA UDI
Coopersurgical, Inc.·00888937025040·G73 Dry Bath Incubator
ArgenZ HT+ 98x20 C3
FDA UDI
ARGEN CORPORATION, THE·D818122065·Dental porcelain/ceramic restoration kit
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X1220650·12mm H x 20mm W x 65mm L x 0 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587L122065120·12mm H x 20mm W x 65mm L XLIF Trial 12 degree L...
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X122065120·12mm H x 20mm W x 65mm L x 12 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X12206580·12mm H x 20mm W x 65mm L x 8 degrees XLIF
SINTEA BIOTECH TRAUMAFIX SYSTEM, MODEL TFX.00.00.X
FDA 510(k)
FDA Class 2
·Orthopedic
SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
EPIC II CRITICAL CARE BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 21, 2013
UNKNOWN DEPUY PATELLA
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code HTG·June 3, 2011
ONE TOUCH ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·August 14, 2008
Brand Name: K-Systems Product Name: G73 Dry Bath Incubator Model/Catalog Number: K22065 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: N/A
FDA Enforcement
Class II
·Ongoing·CooperSurgical, Inc.·December 25, 2024
Brand Name: K-Systems Product Name: G73 Dry Bath Incubator Model/Catalog Number: K22065 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: N/A
FDA Recall
Open, Classified
·CooperSurgical, Inc.·Product code PUB·November 15, 2024