15 results
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33ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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KAVO EVEREST ZS-BLANK MODELS, 42, 20, AND 60
FDA 510(k)
FDA Class 2
·Dental
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120320811·Diamond, cylinder rounded edge, COOL DIAMANT, m...
DYNAMIC COMPRESSION SHAPE MEMORY ALLOY (SMA) STAPLE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PROLITE / PLASMALITE MPX PULSED LIGHT SYSTEM (PERMANENT HAIR REDUCTION)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GOBED II MED/SURG BED
FDA Adverse Event
Malfunction
·FLEXTRONICS EMS CANADA·Product code FNL·March 6, 2013
SPRINT QUATTRO SECURE
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·March 28, 2011
ASCENSIA BREEZE2 TEST STRIPS (50)
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE, LLC·Product code NBW·April 18, 2008
M2A-MAGNUM 42-50MM TPR INSRT-6
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·November 2, 2015
M2A-MAGNUM PF CUP 56ODX50ID
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·July 22, 2015
M2A-MAGNUM MOD HD SZ 50MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·July 22, 2015
Spirit Plus Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
Spirit Select Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
smiths medical portex BLUperc Percutaneous Diliation Procedural Trays with BLUselect tracheostomy tubes, labeled as follows: 1) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 7.0 mm BLUselect trach tube, Item Number 101/561/070; 2) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 8.0 mm BLUselect trach tube, Item Number 101/561/080; 3) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 9.0 mm BLUselect trach tube, Item Number 101/561/090; 4) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 7.0 mm BLUselect SuctionAid trach tube, Item Number 101/563/070; 5) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 8.0 mm BLUselect SuctionAid trach tube, Item Number 101/563/080; 6) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 9.0 mm BLUselect SuctionAid trach tube, Item Number 101/563/090; 7) BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 7.0 mm BLUselect trach tube (drugs, US ONLY), Item Number 101/595/070; 8) BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 8.0 mm BLUselect trach tube (drugs, US ONLY), Item Number 101/595/080; 9) BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 9.0 mm BLUselect trach tube (drugs, US ONLY), Item Number 101/595/090; 10) BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 7.0 mm BLUselect SuctionAid trach tube (drugs, US ONLY), Item Number 101/596/070; 11) BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 8.0 mm BLUselect SuctionAid trach tube (drugs, US ONLY), Item Number 101/596/080; 12) BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 9.0 mm BLUselect SuctionAid trach tube (drugs, US ONLY), Item Number 101/596/090
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 18, 2024
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018
Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025