18 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SENSATION SHORT THROW, CAPTIFLEX, CAPTIVATOR, CAPTIVATOR II, PROFILE, SINGLE-USE POLYPECTOMY SNARES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Prestige® Orthopaedic
FDA UDI
INNOVATIVE HEALTHCARE CORPORATION·10813172022360·Gloves, Surgical, Latex, Powder-Free, Textured,...
NC Screw-retained Abutment
FDA UDI
BIO CONCEPT Co., Ltd.·06947600381112·
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702270495·Elvarex 3/Thigh High/Open Toe-Elephantiasis-Ver...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702554892·ELVAREX 3/KNEE HIGH/PROFILE-SLANT-OPEN TOE/DOTT...
Freedom Pedicle Screw System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215027223·
IO FIX HAND, IO FIX FOOT, EXTREMITY MEDICAL SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MEDTRONIC RESTING HEART SYSTEM, MODEL AAR1000 AND 711
FDA 510(k)
FDA Class 2
·Cardiovascular
BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·August 14, 2023
COGNIS
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·October 1, 2014
OT VERIO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 29, 2013
ASKU
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA INC.·Product code DTE·June 16, 2011
EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
FDA Adverse Event
Malfunction
·AIZU OLYMPUS CO., LTD.·Product code FDS·July 22, 2022
HYALGAN
FDA Adverse Event
Injury
·FIDIA FARMACEUTICI S.P.A.·Product code MOZ·March 23, 2011
HYALGAN
FDA Adverse Event
Injury
·FIDIA FARMACEUTICI S.P.A.·Product code MOZ·March 23, 2011
MAYFIELD INFINITY XR2 BASE UNIT, EXTENDED
FDA Adverse Event
Malfunction
·INTEGRA LIFESCIENCES CORP (INTEGRA-OHIO)·Product code FWZ·February 15, 2017
LASSO® 2515 NAV ECO VARIABLE CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code DRF·November 21, 2012
Alaris PC unit, model 8015, with version 9.12-Keyboard Processor and logic board assembly part number TC10006584. The Alaris PC Unit is the main user interface unit and power supply of the Alaris System, a modular system to be used with Alaris System modules intended for use in todays growing professional healthcare environment for facilities that utilize infusion and/or monitoring devices.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 14, 2013