13 results
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19ms
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Sources: EU EUDAMED, US FDA
CELLSOFT(TM)-CASA (SERIES 1000,2000 & 3000)
FDA 510(k)
FDA Class 2
·Hematology
Medline Industries, Inc.
FDA UDI
MEDLINE INDUSTRIES, INC.·10888277999114·DISPOSABLE FACE MASK KIT
MEDICAL GLOVE SERIES
FDA 510(k)
FDA Class 1
·General Hospital
Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy System (Invia Motion - Endure, Invia Motion 120 days, Invia Motion 60 days, Invia Motion 30 days, Invia Motion 15 days, Invia Motion 7 days), Invia Liberty Negative Pressure Wound Therapy System, Invia Gauze Dressing Kits with FitPad
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
G7 OSSEOTI
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·December 31, 2025
ENDOPATH 5MM CURVED SCISSORS
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GEI·June 13, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 11, 2010
UNKNOWN NECK
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS CORK·Product code MEH·December 6, 2012
UNKNOWN SCREW
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·March 25, 2026
UNKNOWN SCREW
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·March 25, 2026
UNKNOWN SCREW
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·March 25, 2026
PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026