25 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TEMPO AQUA ANGIOGRAPHIC CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
Implant Prosthetics
FDA UDI
Preat Corporation·00842092130995·NobelBiocare™ Tri-Lobe-compatible RP Straight M...
Leksell Stereotactic System
FDA UDI
Elekta Instrument AB·07340048305235·ARC STOP SLIDE
Implant Prosthetics
FDA UDI
Preat Corporation·00842092116555·NobelBiocare™ Tri-Lobe-compatible RP Straight M...
PowerPICC
FDA UDI
Bard Access Systems, Inc.·00801741109553·Catheter Placement Kit
NUZONE NITRILE SURGICAL GLOVES POWDER FREE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TUFF PRO IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·March 30, 2025
ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·March 12, 2013
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·February 1, 2011
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS, INC·Product code JAA·February 21, 2008
RESOLUTION CLIP CLIPPING DEVICE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MND·February 15, 2012
RESOLUTION CLIP CLIPPING DEVICE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MND·February 15, 2012
RESOLUTION CLIP CLIPPING DEVICE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MND·February 15, 2012
RESOLUTION CLIP CLIPPING DEVICE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MND·February 15, 2012
RESOLUTION CLIP CLIPPING DEVICE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MND·February 15, 2012
RESOLUTION CLIP CLIPPING DEVICE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MND·February 15, 2012
BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015
Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD, Inc.·August 8, 2012
BrightView, Gamma Camera System, Product Code 882480.
FDA Enforcement
Class II
·Ongoing·Philips North America·January 17, 2024