23 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SOAR Retractor System
FDA UDI
SPINEOLOGY INC.·M7403041510·15mm x 100mm Portal Tube
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07310K0115100·Handle, Targeting Needle
PC
FDA UDI
Allied Medical, LLC·00026072013038·ADPTR,M/S,CO2,1/4"MPT
STITH BSSO LINGULA RETRAC 10mm
FDA UDI
W.H. Holden, Inc.·D928200415100·
BD 60ML SYRINGE LUER-LOK TIP
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·April 28, 2021
OS-2000 OPTICAL SONOGRAPHY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
MULTI HI-FLO PNEU, WISAP #7080
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
BD LUER-LOK DISPOSABLE SYRINGE WITH BD LUER-LOK TIP
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·April 23, 2021
BD LUER-LOK DISPOSABLE SYRINGE WITH BD LUER-LOK TIP
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·May 19, 2021
REMSTAR AUTO M SERIES
FDA Adverse Event
Injury
·RESPIRONICS, INC.·Product code BZD·April 14, 2024
LIFESHIELD LATEX FREE SYMBIQ PUMP SET
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·May 16, 2012
UNK
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·February 23, 2011
UNK
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·July 1, 2010
UNK
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·January 7, 2011
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - AIBONITO·Product code FPA·April 8, 2013
NEW LIGASURE 5MM
FDA Adverse Event
Malfunction
·COVIDIEN LP (VALLEYLAB)·Product code GEI·March 10, 2011
CONTAK RENEWAL 3
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code NIK·May 8, 2008
SYRINGE 3ML LL 200 S/C
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·May 28, 2021
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
FDA Enforcement
Class I
·Ongoing·Thoratec Corp.·May 8, 2024