21 results
·
22ms
·
Sources: EU EUDAMED, US FDA
PROCEED MULTI-LAYER LAMINATE MESH
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·June 16, 2006
PROCEED TRILAMINATE SURGICAL MESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PROCEED MULTI-LAYER LAMINATE MESH
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·June 26, 2006
PROCEED MULTI-LAYER LAMINATE MESH
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·June 26, 2006
PROCEED MULTI-LAYER LAMINATE MESH
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·June 27, 2006
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR20319251·BioStarter wires Euro-Smile-F. mand. .010"
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATES
FDA 510(k)
FDA Class 2
·Microbiology
HYPODERMIC NEEDLE-PRO NEEDLE WITH NEEDLE PROTECTION DEVICE; HYPODERMIC NEEDLE-PRO SYRINGE & NEEDLE WITH NEEDLE PROTECTIO
FDA 510(k)
FDA Class 2
·General Hospital
BD ANGIOCATH IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·November 12, 2020
BD ANGIOCATH IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·February 18, 2021
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 28, 2013
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·March 28, 2011
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·April 17, 2008
GUIDE WIRE, BALL-TIPPED, STERILE T2 HUMERUS Ø2.5X800 MM
FDA Adverse Event
Injury
·STRYKER TRAUMA KIEL·Product code LXH·April 25, 2016
Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. 2 Model Numbers are used for this same Burette Administration Set described as 110 inch length/279 cm, 16.5ml priming volume, 60 drops/ml, 3 standard injection sites. Model Number I8C1630 (Reorder No. 21-0319-25) for product distributed Internationally. Model Number 8C1630 (Reorder No. 21-0306-01) for product distributed within the United States.
FDA Recall
Terminated
·Smiths Medical MD, Inc.·Product code FPA·December 3, 2004
Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014
Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
FDA Enforcement
Class II
·Terminated·Unomedical As·July 1, 2015
Spirit Plus Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
Spirit Select Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012