13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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JUGGERLOC BONE TO BONE IMPLANTS/ BONE INSTRUMENTS/ BONE IMPLANT AND INSTRUMENT KITS
FDA 510(k)
FDA Class 2
·Orthopedic
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221037060·Unitek(TM) Bicuspid Band General Purpose Narrow...
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613090654·Adson Periostel Elevator Chisel
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973578·
GMD UNIVERSAL URINARY INCONTINENCE SLING
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ELECTRO
FDA 510(k)
FDA Class 2
·Physical Medicine
NEEDLE SFTYGLD 23X1 RB MCK
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMI·December 29, 2020
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 3, 2014
ATTAIN ABILITY
FDA Adverse Event
Death
·MPRI·Product code OJX·June 3, 2013
ASR UNI FEMORAL IMPL SIZE 51
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 22, 2011
UNKNOWN
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·November 17, 2016
PKG, GRASPER FORCEPS, SERRSTED FENESTRATED, P/N 0250080318. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014
Various products which were contract sterilized.
FDA Enforcement
Class II
·Ongoing·Anewmed Corporation·November 6, 2019