22 results · 23ms · Sources: EU EUDAMED, US FDA

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LDR SPINE ROI-A INTERBODY FUSION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

Bone cutters

FDA UDI
DFS - DIAMON GmbH·04057176163318·Bone cutter C162 HP 1,6mm

Lacrimal Cannula

FDA UDI
Medetz Surgical Instruments LLC·G22311032740·Bailey Lacrimal Cannula, 27g with 19g reinforce...

SURGICAL FACE MASK; SURGICAL FACE MASK

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

HEARTWAY POWER CHAIR, P23

FDA 510(k)
FDA Class 2 ·Physical Medicine

Iconacy i-Hip

FDA UDI
Iconacy Orthopedic Implants LLC·M914011032706200·HXLP LINER, 36MM I.D. X 62MM O.D., EXTD WALL

Iconacy i-Hip

FDA UDI
Iconacy Orthopedic Implants LLC·M914011032706400·HXLP LINER, 36MM I.D. X 64MM O.D., EXTD WALL

Iconacy i-Hip

FDA UDI
Iconacy Orthopedic Implants LLC·M914011032705800·HXLP LINER, 36MM I.D. X 58MM O.D., EXTD WALL

Iconacy i-Hip

FDA UDI
Iconacy Orthopedic Implants LLC·M914011032705400·HXLP LINER, 36MM I.D. X 54MM O.D., EXTD WALL

Iconacy i-Hip

FDA UDI
Iconacy Orthopedic Implants LLC·M914011032706000·HXLP LINER, 36MM I.D. X 60MM O.D., EXTD WALL

Iconacy i-Hip

FDA UDI
Iconacy Orthopedic Implants LLC·M914011032705600·HXLP LINER, 36MM I.D. X 56MM O.D., EXTD WALL

DEXCOM G6 GLUCOSE PROGRAM CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·May 7, 2025

VERSAFITCUP DOUBLE MOBILITY LINER Ø 54/28

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·November 15, 2017

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 13, 2013

PRIME CARE (R) TRANSCEND ADVANCED MATTRESS

FDA Adverse Event
Malfunction ·PRIMUS MEDICAL, LLC·Product code IKY·September 10, 2014

ADVANTAGE SERIES 26

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FPO·May 20, 2011

SENSATION PLUS 8FR. 50CC IAB

FDA Adverse Event
Malfunction ·DATASCOPE CORP. - FAIRFIELD·Product code DSP·May 10, 2022

SENSATION PLUS 7.5FR. 40CC IAB

FDA Adverse Event
Malfunction ·DATASCOPE CORP. - FAIRFIELD·Product code DSP·February 23, 2021

SENSATION 7FR. 34CC IAB

FDA Adverse Event
Death ·DATASCOPE CORP. - FAIRFIELD·Product code DSP·February 2, 2021

Ultrasound Video Gastroscope, Model EG-3670URK, The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.

FDA Enforcement
Class II ·Terminated·Pentax of America Inc·August 30, 2017