23 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AVT NATURASOFT
FDA 510(k)
FDA Class 2
·Ophthalmic
CoRoent
FDA UDI
Nuvasive, Inc.·00887517577252·CoRoent Ant TLIF PEEK, 12x11x32mm 4°
Z Liquid HT C2-S 100ml
FDA UDI
ARGEN CORPORATION, THE·D818121324·Dental porcelain/ceramic restoration kit
TASMIN R 12°
FDA UDI
SIGNUS Medizintechnik GmbH·04047844014967·The basic shape of the TASMIN R devices is a ho...
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515016613·Hegar NH, stubby jaw, 8"
GE ECHOPAC MODEL BT10
FDA 510(k)
FDA Class 2
·Radiology
FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAILING SYSTEM)
FDA 510(k)
FDA Class 2
·Orthopedic
ANGEL SYSTEM WITH ASPIRATION KIT W/ ACDA
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code ORG·March 5, 2019
ARTHREX ANGEL SYSTEM WITH ASPIRATION KIT
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code ORG·May 1, 2019
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 20, 2013
ALARIS SYSTEM PUMP MODULE
FDA Adverse Event
Other
·CARDINAL HEALTH ALARIS PRODUCTS·Product code FRN·August 13, 2008
TOTAL ASR ACET IMP SIZE 58
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·June 1, 2011
ARCHITECT B12 REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code CDD·April 17, 2025
INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code PKL·September 29, 2023
ALINITY I B12 REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code CDD·January 27, 2025
ALINITY I B12 REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code CDD·September 22, 2025
ARTIS Q biplane with Material 10848282- - a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography system developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis zee includes cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee can also support the acquisition of position triggered imaging for spatial data synthesis.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·November 21, 2018
Artis Q biplane, Model Number 10848282
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022
XTANT Medical, ## mm x ## mm x # mm x # ,Lordotic/Packaged InTice - C, Sterile R, Single Use Only, for the following Reference numbers/ Primary DI Number/Material Grade on Label: Ref: X098-0106-STR DI Number: M697X0980106STR1 Mat.: CP Ti Grade 3, Ref: X098-0107-STR DI Number: M697X0980107STR1 Mat.: CP Ti Grade 4, Ref: X098-0108-STR DI Number: M697X0980108STR1 Mat.: CP Ti Grade 5, Ref: X098-0109-STR DI Number: M697X0980109STR1 Mat.: CP Ti Grade 6, Ref: X098-0110-STR DI Number: M697X0980110STR1 Mat.: CP Ti Grade 7, Ref: X098-0111-STR DI Number: M697X0980111STR1 Mat.: CP Ti Grade 8, Ref: X098-0112-STR DI Number: M697X0980112STR1 Mat.: CP Ti Grade 9, Ref: X098-0205-STR DI Number: M697X0980205STR1 Mat.: CP Ti Grade 10, Ref: X098-0206-STR DI Number: M697X0980206STR1 Mat.: CP Ti Grade 11, Ref: X098-0207-STR DI Number: M697X0980207STR1 Mat.: CP Ti Grade 12, Ref: X098-0208-STR DI Number: M697X0980208STR1 Mat.: CP Ti Grade 13, Ref: X098-0209-STR DI Number: M697X0980209STR1 Mat.: CP Ti Grade 14, Ref: X098-0210-STR DI Number: M697X0980210STR1 Mat.: CP Ti Grade 15, Ref: X098-0211-STR DI Number: M697X0980211STR1 Mat.: CP Ti Grade 16, Ref: X098-0212-STR DI Number: M697X0980212STR1 Mat.: CP Ti Grade 17, Ref: X098-0305-STR DI Number: M697X0980305STR1 Mat.: CP Ti Grade 18, Ref: X098-0306-STR DI Number: M697X0980306STR1 Mat.: CP Ti Grade 19, Ref: X098-0307-STR DI Number: M697X0980307STR1 Mat.: CP Ti Grade 20, Ref: X098-0308-STR DI Number: M697X0980308STR1 Mat.: CP Ti Grade 21, Ref: X098-0309-STR DI Number: M697X0980309STR1 Mat.: CP Ti Grade 22, Ref: X098-0310-STR DI Number: M697X0980310STR1 Mat.: CP Ti Grade 23, Ref: X098-0311-STR DI Number: M697X0980311STR1 Mat.: CP Ti Grade 24, Ref: X098-0312-STR DI Number: M697X0980312STR1 Mat.: CP Ti Grade 25
FDA Enforcement
Class III
·Terminated·XTANT Medical·November 18, 2020
Artis Q Interventional Fluoroscopic X-Ray System, Model Numbers 10848280, 10848281, 10848282, 10848283, 10848354 & 10848355
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 26, 2018