17 results
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39ms
·
Sources: EU EUDAMED, US FDA
3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)
FDA 510(k)
FDA Class 2
·Ophthalmic
ACE
FDA UDI
ACE SURGICAL SUPPLY CO., INC.·00614950025336·6' DISS SWIVEL TO PURITAN MALE OXYGEN HOSE ASSE...
Intrigue
FDA UDI
LANCER ORTHODONTICS, INC.·00817573021369·INTRG WHISP MBT CUS HK0T +8A 018 UL
SCANLUBE
FDA 510(k)
FDA Class 2
·Radiology
AMPCARE ESP THERAPY SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
BD LUER-LOK¿ SYRINGE STERILE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·February 10, 2022
BD INTIMA-II CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·April 9, 2021
RIGID OPTICAL STONE CRUSHING FORCEP 30 DEGREE
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY SAN JOSE·Product code GEI·July 25, 2011
ACCENT DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·November 6, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·July 17, 2013
INTIMA-II Y 24GAX0.75IN PRN/EC SLM
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·December 17, 2020
BD INTIMA-II CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·December 28, 2020
BD INTIMA-II CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·December 16, 2020
ARCTIC SUN® 5000
FDA Adverse Event
Malfunction
·MEDIVANCE -1725056·Product code DWJ·December 2, 2025
RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014
UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.
FDA Enforcement
Class II
·Terminated·Zimmer Surgical Inc·November 12, 2014
BIOMET StageOne Knee Tibial Cement Spacer Mold, 80 MM, Silicone, Sterile, Item 433180.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020