23 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K0140400·Driver Shaft, T30 Final Cap Driver
FAMILY OF ALTUS MEDICAL MODIFIED COOLGLIDE AESTHETIC LASERS, MODELS COOLGLIDE I, II AND FUTURE MODELS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ENT-single-use suction tubes, angled
FDA UDI
Spiggle & Theis Medizintechnik GmbH·04250381815076·suction control on top
140x4....
UNIVERSAL THREAD
FDA UDI
FGX INTERNATIONAL INC.·00193033574966·
UNIVERSAL THREAD
FDA UDI
FGX INTERNATIONAL INC.·00196365849320·
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0100400·Assembly, Caddie, Curved Rods
REDTECH GIPC 2000
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SLEEVED FILTER
FDA 510(k)
FDA Class 2
·Anesthesiology
GOOD SAM CINCINNATI OH 1
FDA Adverse Event
Malfunction
·SORIN GROUP USA, INC.·Product code DWE·December 11, 2008
ARROW CVC SET: 3-LUMEN 12 FR X 16 CM
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL LLC·Product code FOZ·March 31, 2022
ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL LLC·Product code LFJ·January 12, 2023
ICON PREMO
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZD·November 20, 2024
ICON PREMO
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZD·June 26, 2025
ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL LLC·Product code LFJ·January 12, 2023
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 21, 2013
IDENTITY XL DR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWP·March 10, 2011
SPACEMAKER BLUNT TIP TROCAR 12MM
FDA Adverse Event
Malfunction
·PONCE - USS·Product code GCJ·March 14, 2008
POCKET DOP II
FDA Adverse Event
Malfunction
·NATUS NEUROLOGY INCORPORATED·Product code JAF·March 25, 2020
ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC.·Product code MPB·January 20, 2022
WALLACH LL 100 cryosurgical units: LL100 Cryosurgical - Part Number 900001; LL110 with Pinned Yoke - Part Number 900019-70; LL100 Multi Tip W/TC - Part Number: 900629; LL100 - CO2 - Part Number 900162
FDA Enforcement
Class II
·Terminated·CooperSurgical, Inc.·April 22, 2015