11 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)
FDA 510(k)
FDA Class 2
·General Hospital
NA
FDA UDI
Stryker GmbH·00886385008875·Titanium Ankle Fusion Nail, Left
Needle aspiration and injection
FDA UDI
KATENA PRODUCTS, INC.·00841668113622·PERIBULBAR NEEDLE 25GA 32MM
TruFit™
FDA UDI
Ortho Organizers, Inc.·00190707192044·TruFit 2.0 022 MC LR6/7 NC SBT -10T 0DOff DB SB...
SURGERY REHEARSAL PLATFORM
FDA 510(k)
FDA Class 2
·Radiology
LIFESITE HEMODIALYSIS ACCESS SYSTEM, CANNULA EXCHANGE KIT, INSERTION KIT, ACCESS CANNILA
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
IDENTITY SR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·November 10, 2008
NOVA MAX GLUCOSE MONITOR
FDA Adverse Event
Other
·NOVA BIOMEDICAL CORPORATION·Product code NBW·May 27, 2011
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 10, 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