29 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Nitrile Patient Examination Gloves
FDA 510(k)
FDA Class 1
·General Hospital
Orfit Industries
FDA UDI
Orfit Industries NV·05420028705018·Head, Neck and Shoulders Base Plate in CFL exte...
Zavation
FDA UDI
Zavation LLC·00842166132641·Ti3Z CIF 13mmx15mmx12mm -10 deg
PMT® Halo Systems
FDA UDI
PMT CORPORATION·00650551110378·HALO, 1203-5 VEST PED00, COOLMAX LINER, 1211-1 ...
10PC - UP - 380-54620 - Locamotive
FDA UDI
Certified Safety Manufacturing, Inc.·00766588110127·10PC - UP - 380-54620 - Locamotive
EVOS Lumbar Interbody System
FDA UDI
Cutting Edge Spine, LLC·00841193114439·HA PEEK EVOS Straight, ,12mmx11mmx 30mm , FLAT ...
ELISA enzyme conjugate, anti-human IgA
FDA UDI
EUROIMMUN Medizinische Labordiagnostika AG·04049016151562·
SBRT
FDA UDI
Orfit Industries NV·05401172039495·
POWDER FREE NITRILE EXAMINATION GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (BLUE/GREEN) (AND MULTIPLE LABELS)
FDA 510(k)
FDA Class 1
·General Hospital
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 22, 2024
ACCELERATOR A3600
FDA Adverse Event
Malfunction
·INPECO SA·Product code JQP·December 20, 2024
SD01 65/16
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NVY·October 29, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 13, 2011
CONTAK RENEWAL
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 8, 2013
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 18 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-118/00
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·August 16, 2023
VIDAS SARS-COV-2 IGG
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code QKO·February 18, 2021
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.
FDA Recall
Terminated
·Synthes (USA) Products LLC·Product code GXQ·December 8, 2015
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.
FDA Recall
Terminated
·Synthes (USA) Products LLC·Product code GXQ·December 8, 2015
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.
FDA Recall
Terminated
·Synthes (USA) Products LLC·Product code GXQ·December 8, 2015