11 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Omnipod GO Insulin Delivery Device
FDA 510(k)
FDA Class 2
·General Hospital
Wrist Lacer II
FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357233724·
NON-BIOABSORBABLE STAPLE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
GLIDEWELL HT IMPLANT Ø5.0 X 10 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·January 3, 2025
MINICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·August 25, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 4, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 12, 2013
Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
FDA Enforcement
Class II
·Ongoing·Electro Medical Systems SA·May 1, 2024
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018