21 results · 22ms · Sources: EU EUDAMED, 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