13 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Bernafon
FDA UDI
Bernafon AG·05711583025599·CL80 ITCW, WL L BE CELEBRATE 80
MODEL 950-12L HOLTER RECORDER WITHOUT ANALYSIS
FDA 510(k)
FDA Class 2
·Cardiovascular
SEVEN STAR NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
BLUNT TIP SCREW, ÿ 4X48MM
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code HSB·April 29, 2025
TENSION FREE VAGINAL TAPE - ABBREVO UNKNOWN PROD
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·September 28, 2018
TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·September 28, 2018
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 8, 2014
LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 MEDIUM-LARGE TITANIUM LIGA
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code FZP·September 10, 2008
6800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 24, 2011
EDI BZO Uncut Sheet - Cup*, Item No. 160170
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 9, 2014