20 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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OSCILLAIRE
FDA 510(k)
FDA Class 2
·Anesthesiology
Sphero Attachment
FDA UDI
Preat Corporation·00842092113943·Sphero Block Abutment Astra 3.0 x 1mm (2.5mm Ball)
Zavation
FDA UDI
Zavation LLC·00842166174894·Reduction Head Assembly
Bioplate®
FDA UDI
Bioplate, Inc.·M3848120010·Straight Plate - Ø1.5 mm - 4 hole - 19 mm
CONMED
FDA UDI
Conmed Corporation·20653405008481·MONOPOLAR ELECTROSURGICAL FORCEPS, 7-1/2" HAND-...
A.T.S.®
FDA UDI
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024376526·Dual Hose Sterile 36 Inches
Flagship HS
FDA UDI
BRIVANT LIMITED·00816349010989·
Bioplate®
FDA UDI
Bioplate, Inc.·M384812001CP1·Straight Plate - Ø1.5 mm - 4 hole - 19 mm
Bioplate®
FDA UDI
Bioplate, Inc.·M384812001US0·Straight Plate - Ø1.5 mm - 4 hole - 19 mm
SMARTSCREW
FDA 510(k)
FDA Class 2
·Orthopedic
Acucy Influenza A&B Test with the Acucy System
FDA 510(k)
FDA Class 2
·Microbiology
SYNVISC
FDA Adverse Event
Injury
·GENZYME BIOSURGERY·Product code ---·July 31, 2002
PROMUS PREMIER?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·May 15, 2014
CONSULTA CRT-P
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code NVZ·October 31, 2012
PUMP MMT-522NAB PRDGM INS V2.2 BL EN
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·August 17, 2010
BD ECLIPSE¿ SAFETY NEEDLE - 23G
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·December 6, 2022
HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN)
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GEI·December 17, 2019
Sterile Water: Product Name/Product Code: USP STERILE WATER SYRINGE/1030A, SYRINGE PREFILLED 10 ML/6496722, 30CC PREFILLED SYRINGE/6496723, USP STERILE WATER SYRINGE/1030, 10CC PREFILLED SYRINGES/51638, 30CC PREFILLED SYRINGES/52333, 10CC PREFILLED SYRINGES/1010
FDA Enforcement
Class I
·Ongoing·Nurse Assist, LLC·December 27, 2023
Ingenia Ambition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781359
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021
Ingenia 3.0T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781271
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021