16 results · 24ms · Sources: EU EUDAMED, US FDA

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AEVUMED PHANTOM Suture Anchors

FDA 510(k)
FDA Class 2 ·Orthopedic

MAESTRO TOTAL WRIST

FDA UDI
Biomet Orthopedics, LLC·00880304555266·

Maestro™ Total Wrist

FDA UDI
Biomet Orthopedics, LLC·00887868240102·

UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION

FDA 510(k)
FDA Class 2 ·Immunology

INNESIS PEEK CAGE

FDA 510(k)
FDA Class 2 ·Orthopedic

RESOLUTE INTEGRITY RX

FDA Adverse Event
Malfunction ·MEDTRONIC IRELAND·Product code NIQ·January 8, 2019

ENDEAVOR RX

FDA Adverse Event
Malfunction ·MEDTRONIC IRELAND·Product code NIQ·January 8, 2019

Y-KNOT ALL SUTURE ANCHOR

FDA Adverse Event
Injury ·CONMED LINVATEC·Product code MBI·June 20, 2013

MITEK NON ABSORBABLE ANCHOR IMPLANT

FDA Adverse Event
Injury ·DEPUY MITEK·Product code JDR·July 27, 2011

SJM EPIC STENTED TISSUE VALVE

FDA Adverse Event
Injury ·ST JUDE MEDICAL BRASIL LTD.·Product code LWR·September 26, 2008

BINAXNOW COVID-19 ANTIGEN SELF-TEST

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·September 22, 2022

BINAXNOW COVID-19 ANTIGEN SELF-TEST

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·September 22, 2022

BINAXNOW COVID-19 ANTIGEN SELF-TEST

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·September 22, 2022

Artis icono biplane- Model No. 11327600 Artis icono floor- Model No. 11327700

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc·September 7, 2022

Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397, 397T, 386, 386T, 396, 396T)

FDA Enforcement
Class II ·Ongoing·Medtronic Inc.·November 29, 2017

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS25; b) PAED. TRACHEOSTOMY TUBE 3.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS30; c) PAED. TRACHEOSTOMY TUBE 3.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS35; d) PAED. TRACHEOSTOMY TUBE 4.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS40; e) PAED. TRACHEOSTOMY TUBE 4.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS45; f) PAED. TRACHEOSTOMY TUBE 5.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS50; g) PAED. TRACHEOSTOMY TUBE 5.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS55

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024