17 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TTC Phantom® Intramedullary Nail System
FDA 510(k)
FDA Class 2
·Orthopedic
Sonic
FDA UDI
Sonic Innovations, Inc.·05711583033136·ET20, KIT 13 2.4G NFM L BE ENCHANT 20
Publix Short Needle Insulin Syringe
FDA UDI
PUBLIX SUPER MARKETS, INC.·10041415022789·Publix 3/10cc, 5/16 inch x 31 gauge insulin syr...
Edge™ Diamond FR016-3.4M Football Round
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172003148·Diamond dental bur, reusable
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123823·K-WIRE - DOUBLE TROCAR 1.6mm DIA x 75mm
REALSEAL XT SEALER
FDA 510(k)
FDA Class 2
·Dental
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168KB
FDA 510(k)
FDA Class 2
·Cardiovascular
DUETTO MT
FDA Adverse Event
Malfunction
·QUANTA SYSTEM S.P.A.·Product code GEX·April 14, 2022
PUBLIX
FDA Adverse Event
Malfunction
·ULTIMED, INC·Product code FMF·June 6, 2016
OT VERIO2 METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 12, 2015
OT VERIO2 METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 12, 2015
CORDIS LUMEND OUTBACK LTD RE-ENTRY CATHETER
FDA Adverse Event
Other
·Product code DQY·October 7, 2008
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 27, 2013
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FPA·August 4, 2011
PROAQT SENSOR
FDA Adverse Event
Malfunction
·PULSION MEDICAL SYSTEMS SE·Product code DXG·August 18, 2025
PROAQT SENSOR
FDA Adverse Event
Malfunction
·PULSION MEDICAL SYSTEMS SE·Product code DXG·August 18, 2025
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems·October 10, 2018