19 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
CoRoent
FDA UDI
Nuvasive, Inc.·00887517565198·CoRoent Ant TLIF PEEK, 13x11x30mm 0°
Clear Readers
FDA UDI
Diversified Products, Inc.·00842894138397·
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702595543·ELVAREX 2/KNEE HIGH/SLANT-CLOSED TOE-ELEPHANTIA...
CASTROVIEJO CORNEOSCLERAL SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896014152·CASTROVIEJO CORNEOSCLERAL SCISSORS SMALL RIGHT ...
SENSTOUCH NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE (GREEN, ORANGE, VIOLET AND WHITE)
FDA 510(k)
FDA Class 1
·General Hospital
IBC FLOPUMP WITH GBS COATING
FDA 510(k)
FDA Class 2
·Cardiovascular
M-SERIES
FDA UDI
Savaria Concord Lift·10688503001556·Patient lifter
GMK-PRIMARY FEMUR PS CEMENTED SIZE 6 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·July 16, 2020
GMK-PRIMARY FEMUR PS CEMENTED SIZE 4
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·May 22, 2019
GMK-PRIMARY FEMUR PS CEMENTED SIZE 4 LEFT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·August 23, 2017
GMK-PRIMARY FEMUR PS CEMENTED SIZE 6 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 25, 2018
ITREL 4
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·March 13, 2013
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·October 1, 2014
INTEGRITY MULTI CURE
FDA Adverse Event
Injury
·DENTSPLY CAULK·Product code EBG·May 15, 2013
DIAMOND 3
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code DXY·June 16, 2011
INTELLIS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·February 5, 2024
INTELLIS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·February 6, 2025
BIOMET 3i, PROVIDE IMPRESSION COPINGS, Catalog # PIC484, PIC484H, PIC485, PIC485H, PIC654, PIC654H, PIC655, and PIC655H BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·January 13, 2016