11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HAND-TROL S
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Gen. Acces/ Instr. Tip Guard
FDA UDI
KATENA PRODUCTS, INC.·00841668110850·TIP GUARDS VENTED WHITE PACK OF 100
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515240377·Jansen Middleton Sept Fcps, 14mm, cut jaws
Monster Screw System
FDA UDI
Paragon 28, Inc.·00889795153135·1.2 X 150 Mm K Wire, Single Ended Trocar Tip, T...
IPL Hair Removal Device Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DENTACOLOR LIGHT CURING CROWN & BRIDGE
FDA 510(k)
FDA Class 2
·Dental
VALVE, ULTRA SMALL, MEDIUM
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROSURGERY·Product code JXG·November 16, 2010
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·January 28, 2013
GREENLIGHT HPS BPH FIBER OPTIC
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)·Product code GEX·July 14, 2014
CODMAN BACTISEAL EVD CATHETER
FDA Adverse Event
Injury
·INTEGRA LIFESCIENCES SWITZERLAND SAR·Product code JXG·February 8, 2021
Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD, Inc.·March 19, 2025