15 results
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25ms
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Sources: EU EUDAMED, US FDA
CLEARINSE
FDA UDI
PENO LLC·CRBFV1·
CLEARinse
FDA UDI
PENO LLC·B423CRPRO1·The CLEARinse Pro is designed to make nasal and...
Shusher Care
FDA UDI
PENO LLC·00850024829367·
CLEARinse Nasal Aspirator
FDA UDI
PENO LLC·CRBFV2·
pNeo LLC
Manufacturer
🇺🇸 United States
PNEO, LLC
FDA registration
PNEO, LLC·6 products·🇺🇸 United States
OTO-TIP EARWAX REMOVAL TOOL
FDA Adverse Event
Injury
·PNEO LLC.·Product code KYZ·April 8, 2026
DERMAPEN (MICRONEEDLING DEVICE)
FDA Adverse Event
Injury
·DERMA PEN, LLC.·Product code QAI·May 14, 2025
PRX-T33 (MICRONEEDLING DEVICE)
FDA Adverse Event
Injury
·DERMA PEN, LLC.·Product code QAI·May 14, 2025
Polarizer D Fixed w/Rotating Red 1 lambda plate. Utilized in upright Zeiss microscopes to aid in diagnosis by means of color variation.
FDA Recall
Terminated
·Zeiss, Carl Inc·Product code IBJ·May 28, 2013
DermaPen Pro Model, Micro Needling System, a motorized AC powered surgical instrument for dermabrasive use. Each motorized handpiece is packaged within a small box. Each disposable needle cartridge is packaged individually and then placed into boxes of 30 quantities per box.
FDA Recall
Terminated
·Derma Pen, LLC·Product code PIU·February 5, 2015
DermaPen Pro Model, Micro Needling System, a motorized AC powered surgical instrument for dermabrasive use. Each motorized handpiece is packaged within a small box. Each disposable needle cartridge is packaged individually and then placed into boxes of 30 quantities per box.
FDA Enforcement
Class II
·Terminated·Derma Pen, LLC·September 16, 2015
5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number 595000-001
FDA Recall
Terminated
·SynCardia Systems Inc.·Product code LOZ·October 21, 2016
Emergo Europe B.V.
Authorized representative
🇳🇱 Netherlands·900 Manufacturers·22100 Devices
SUNGO Europe B.V.
Authorized representative
🇳🇱 Netherlands·1571 Manufacturers·20390 Devices