15 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ZHIDA NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR
FDA 510(k)
FDA Class 1
·General Hospital
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221037121·Unitek(TM) Bicuspid Band General Purpose Wide U...
K2M General Instruments
FDA UDI
VB Spine LLC·10888857580787·Split Tube Retractor Ø20x50 mm
LED TURBO-PEN
FDA 510(k)
FDA Class 2
·Dental
DERMATOLOGICAL TREATMENT DEVICE FAMILY
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CONSTELLATION VISION SYSTEM
FDA Adverse Event
Malfunction
·ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER·Product code HQC·April 15, 2026
RESTORE ULTRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 3, 2013
ASR ACETABULAR CUPS 54
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 22, 2011
6800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 3, 2008
MICROVASCULAR PLUG
FDA Adverse Event
Injury
·REVERSE MEDICAL·Product code KRD·September 8, 2021
MICROVASCULAR PLUG
FDA Adverse Event
Injury
·REVERSE MEDICAL·Product code KRD·September 8, 2021
INTIMA-II Y 22GAX0.75IN PRN/EC SLM
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code FMI·April 30, 2019
DISPOSABLE POLYMER IRRIGATION AND SILICONE IRRIGATION AND ASPIRATION TIPS
FDA Adverse Event
Malfunction
·ALCON RESEARCH, LLC - ALCON PRECISION DEVICE·Product code KYG·March 5, 2026
DISPOSABLE POLYMER IRRIGATION AND SILICONE IRRIGATION AND ASPIRATION TIPS
FDA Adverse Event
Malfunction
·ALCON RESEARCH, LLC - ALCON PRECISION DEVICE·Product code KYG·February 18, 2025
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020