21 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HyperBand
FDA 510(k)
FDA Class 2
·Radiology
Mouthpiece, Disposable Flex, 1-1/16" OD, 2.625" L
FDA UDI
A-M SYSTEMS, LLC·00817081026207·Mouthpiece, Disposable Flex, 1-1/16" OD, 2.625" L
Kirwan
FDA UDI
KIRWAN SURGICAL PRODUCTS LLC·00841019108390·Reusable TPR Bipolar Forceps 7" (17.8cm) Cushin...
Echo® Hip System Instrumentation
FDA UDI
Biomet Orthopedics, LLC·00887868474538·
ECHO(TM) HIP SYSTEM INSTRUMENTATION
FDA UDI
Biomet Orthopedics, LLC·00880304462977·
IMAX CEPH DIGITAL X-RAY SENSOR
FDA 510(k)
FDA Class 2
·Dental
SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
EXPRESS SD RENAL/BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 22, 2025
EXPRESS SD RENAL/BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·January 22, 2025
EXPRESS SD RENAL/BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·September 3, 2025
EXPRESS SD RENAL/BILIARY
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·January 27, 2025
EXPRESS SD RENAL/BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 12, 2025
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 9, 2024
LINER: MPACT FLAT PE HC LINER Ø32/E
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·November 22, 2018
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 24, 2025
EXPRESS SD RENAL/BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·May 13, 2026
ARCOMXL RLC 32MM 10 DEG SZ23
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LZO·June 11, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 14, 2011
ONE TOUCH ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·September 9, 2008
EXPRESS SD RENAL/BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 11, 2025