21 results
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27ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772777662·LUMBAMED BASIC DORSAL STAYS M SILVER IV
Surgical laser fibers
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Operating Scissors
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896114746·Operating Scissors Power Cut Gold Curved Sharp/...
MICRO TYING FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896060609·MICRO TYING FORCEPS STRAIGHT TUNGSTEN CARBIDE D...
PILLING
FDA UDI
TELEFLEX INCORPORATED·04026704417735·SPONGE CHERRY STERILE XRAY FOAM 3/8" 200/ BOX
Sonoma™
FDA UDI
Seaspine Orthopedics Corporation·10889981050825·Sonoma Anterior Cervical Plate 2 Level Plate, 34mm
SCANLAN®
FDA UDI
SCANLAN INTERNATIONAL INC·00846159007510·Satinsky Occlusion Clamp
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319742440·Freer-Joseph Elevator 7" (17.5cm), double-end, ...
HM-LAMP II
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
A1CNOW FOR RX HOME USE
FDA 510(k)
FDA Class 2
·Hematology
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·January 13, 2023
Manta Ray™
FDA UDI
Seaspine Orthopedics Corporation·10889981057091·Plate - 2 Level - 34 mm
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 28, 2025
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE INC.·Product code LZG·October 22, 2014
AQUARIUS
FDA Adverse Event
Malfunction
·NIKKISO MEDICAL SYSTEMS GMBH·Product code KDI·August 11, 2011
SYNCHROMED II
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LKK·July 1, 2013
DENALI FILTER
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·January 17, 2020
MultiDiagnostic-Eleva with Flat Detector 708038 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Nederlands·May 9, 2018
Mutlidiagnost-Eleva with Flat Detector Eleva with Flat Detector 708037 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Nederlands·May 9, 2018
Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722223, (2) 722224, (3) 722225, (4) 722226
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024