19 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Arthrex Self Punching SwiveLock Suture Anchors
FDA 510(k)
FDA Class 2
·Orthopedic
HEALIX TRANSTEND ORTHOCORD PERCANNULA
FDA UDI
Medos International Sàrl·10886705008094·HEALIX TRANSTEND (BR/2) IMPLANT SYSTEM (2) TCP/...
TIPCONTROL
FDA Adverse Event
Injury
·RICHARD WOLF GMBH·Product code GEI·September 8, 2023
14.5-16.0 FRENCH CUFFED CATHETER REMOVAL DEVICE, SYMMETRY SURGICAL SINGEL USE
FDA 510(k)
FDA Class 2
·General Hospital
Luna G3 BPAP System
FDA 510(k)
FDA Class 2
·Anesthesiology
VANGUARD PS BOX REAMER
FDA Adverse Event
Malfunction
·BIOMET INC.·Product code HWE·November 10, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 24, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 12, 2013
Azurion 7 B20 System Model Numbers: (1)722068, (2)722226, (3)722236; Software Version Number - All versions: R1.X, R2.X, R3.X
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 18, 2026
BD KIESTRA IDENTIFA
FDA Adverse Event
Malfunction
·BD KIESTRA LAB AUTOMATION·Product code QBN·October 8, 2025
BD KIESTRA¿ IDENTIFA
FDA Adverse Event
Malfunction
·BD KIESTRA LAB AUTOMATION·Product code QBN·December 9, 2024
HEALIX TRANSTEND BR/2 IMPL SYS
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code HWC·January 17, 2019
Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis·Product code OWB·March 3, 2026
Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236.
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·January 13, 2025
Azurion 7 B20 System Code: (1) 722068 (2) 722226 (3) 722236
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·January 13, 2025
Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Azurion 7 B20 System Code: (1) 722068 (2) 722226 (3) 722236
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 12, 2025
Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
Azurion 7 B20 System Model Numbers: (1)722068, (2)722226, (3)722236; Software Version Number - All versions: R1.X, R2.X, R3.X
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·January 26, 2026