18 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TRITANIUM NON-MODULAR SHELL & X3 ALL-POLY INSERT
FDA 510(k)
FDA Class 2
·Orthopedic
SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FOZ·February 15, 2024
CALIBRITE PERCP-CY5.5 BEADS AND FACSCOMP SOFTWARE
FDA 510(k)
FDA Class 2
·Hematology
MERIDIAN-PORTABLE
FDA 510(k)
FDA Class 2
·Neurology
SYR 10ML PUMP COMPATIBLE SALI NE 10ML FIL
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FOZ·February 2, 2024
SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FOZ·February 22, 2024
SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FOZ·February 5, 2024
SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FOZ·February 22, 2024
SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code NGT·February 1, 2024
SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FOZ·February 22, 2024
BD SAFETY-LOK¿ BLOOD COLLECTION WINGSET 23G X .75 IN, W/ 7 IN TUBING
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·November 27, 2017
FOOTPRINT ULTRA PK SUTURE ANCHOR, 4.5
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code MBI·August 4, 2015
FOOTPRINT ULTRA PK SUTURE ANCHOR, 4.5
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code MBI·July 28, 2015
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 2, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 15, 2014
28MM 0MM V40 ALUMINA HEAD
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS CORK·Product code LZO·May 12, 2011
SHELL 45 MM O.D.
FDA Adverse Event
Injury
·ZIMMER MANUFACTURING B.V.·Product code KWY·August 22, 2022
BIOMET 3i, PROVIDE PROTECTION CAP KITS, Catalog # PAK4140, PAK4155, PAK4240, PAK4255, PAK4340, PAK4355, PAK4440, PAK4455, PAK5140, PAK5155, PAK5240, PAK5255, PAK5340, PAK5355, PAK5440, PAK5455, PAK6140, PAK6155, PAK6240, PAK6255, PAK6340, PAK6355, PAK6440, and PAK6455 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