35 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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IRIS ANTERIOR CERVICAL PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
OsteoMed
FDA UDI
OSTEOMED LLC·00845694031431·1.6mm Modified LeFort Plate, Left, 3mm
LIF-PTP
FDA UDI
ALPHATEC SPINE, INC.·00190376306926·Paddle, Pelvic Positioner
e-scope® F.O. otoscope / ophthalmoscope XL 2.5 V,
FDA UDI
Rudolf Riester GmbH·04045396177024·The Riester otoscope is produced for illuminati...
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481114045·LOCATOR R-Tx Abutment for Regular Platform Tiss...
LOCATOR F-Tx
FDA UDI
Zest Anchors, LLC·00840481121654·LOCATOR F-Tx Abutment for Regular Platform Tiss...
PREASSEMBLED SURGICAL WASH SET
FDA 510(k)
FDA Class 2
·Anesthesiology
SLIT LAMP BO 900, BQ 900, BP900
FDA 510(k)
FDA Class 2
·Ophthalmic
Coselgi
FDA UDI
Widex A/S·05706069666083·Coselgi C-tune II V2.4 DVD
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code ODG·July 24, 2021
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code ODG·July 21, 2021
INSPIRE 7F M N/S
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·December 29, 2025
LIFEPAK CR® PLUS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC. - 3015876·Product code MKJ·May 9, 2011
SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·IDEV TECHNOLOGIES, INC.·Product code FGE·May 22, 2013
CATHETER, ELECTRODE RECORDING
FDA Adverse Event
Injury
·BIOSENSE WEBSTER, INC (IRWINDALE)·Product code DRF·September 30, 2014
INSPIRE 7F M N/S
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA - S.R.L.·Product code DTZ·February 19, 2026
3.2MM Pellet Insertion Tray Catalog Number: B9743
FDA Enforcement
Class II
·Terminated·Busse Hospital Disposables, Inc.·June 8, 2022
HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL VENOUS/CAR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·May 10, 2019
INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA S.R.L.·Product code DTZ·March 10, 2017
INSPIRE 6F HOLLOW FIBER OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·August 3, 2022