23 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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S9 ELOUERA
FDA 510(k)
FDA Class 2
·Anesthesiology
Fuji Cervical Plate System
FDA UDI
Altus Spine, LLC·B41711401241·24mm Level 1 Cervical Plate System - Fuji
GYRUS ACMI, INC
FDA UDI
Gyrus ACMI, LLC·00821925017580·SCHUKNECHT WIRE PISTON SLIM SHAFT .6MM DIAMETER...
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319704547·Rochester (Pean) Hemostatic Forceps 8" (20cm), ...
FETAL DOPPLER JPD-100S
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
FASTX STERNAL INTRAOSSEOUS DEVICE
FDA 510(k)
FDA Class 2
·General Hospital
ONE TOUCH PROFILE
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·May 2, 2002
ROD, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code MNH·May 14, 2019
5.5 TI CANNULATED TRANSLATION SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code NKB·November 27, 2019
DEPUY ASR XL FEM IMP SIZE 49
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD - 8010379·Product code KWA·May 31, 2013
UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·June 25, 2011
MATRIX2 STANDARD 2D SR COIL
FDA Adverse Event
Death
·NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP.·Product code HCG·August 30, 2008
TRUEMETRIX
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH, INC.·Product code NBW·February 9, 2017
POLARIS SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code NKB·January 8, 2020
PEDICLE SCREW UNSPECIFIED
FDA Adverse Event
Malfunction
·ZIMMER BIOMET SPINE INC.·Product code NKB·April 20, 2021
PEDICLE SCREW UNSPECIFIED
FDA Adverse Event
Malfunction
·ZIMMER BIOMET SPINE INC.·Product code NKB·April 20, 2021
PEDICLE SCREW UNKNOWN TYPE/SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code NKB·April 20, 2021
CANNULATED TRANSLATION SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code NKB·December 3, 2020
POLARIS TRANSLATION SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code NKB·November 27, 2019
C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear Accelerator is intended to provide sterotactic radiosurgery and precision radio-therapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·September 24, 2014