16 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG
FDA 510(k)
FDA Class 2
·Cardiovascular
BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA S.R.L.·Product code DTN·February 22, 2017
BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTN·March 24, 2016
BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTN·March 24, 2016
BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTN·July 25, 2018
ADVIA Centaur® BR MCM
FDA UDI
Siemens Healthcare Diagnostics Inc.·00630414182247·BR CA27-29 (US) Master Curve Material Set - CEN...
TROCAR SLEEVE AND ACCESSORIES, MODELS 1287-XX-XX
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BIOPSY HANDY, MRI BIOPSY HANDY
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BILATERAL DOUBLE BALLOON SET
FDA Adverse Event
Malfunction
·PAJUNK GMBH MEDIZINTECHNOLOGIE·Product code KOG·December 7, 2006
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·May 14, 2013
ECHELON 60 ENDOPATH STAPLER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·August 12, 2008
UNKNOWN DEPUY CORT LOCK SCRW (6 EACH)
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code HWC·May 18, 2011
FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
FDA Adverse Event
Injury
·COOK INC·Product code FOZ·November 16, 2018
Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator The CUSA Electrosurgical Module (CEM) provides Desiccate Coagulation waveform electrosurgical capability to CUSA Excel handpieces. The CUSA handpiece with the CEM Nosecone works in conjunction with the Force FX generator in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·February 26, 2014
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
ACCOLADE DR EL MRI (Model L331)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025