15 results · 21ms · Sources: EU EUDAMED, 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