23 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BIORETEC ACTIVASCREW INTERFERENCE
FDA 510(k)
FDA Class 2
·Orthopedic
NA
FDA UDI
STERILMED, INC.·10888551039635·KNIFE, MYRINGOTOMY
Headless Compression Screw
FDA UDI
I.T.S. GmbH·09120047298916·Headless Compression Screw, Cannulated, D=3.0mm...
LCU Hip System - Instruments
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575415694·Orthopaedic joint/limb rongeur - LCU Hip System
General Instrument
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575448531·Modular Box Chisel
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197192071·Tebbet Breast Retractor
130x16...
AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5
FDA 510(k)
FDA Class 2
·Hematology
ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SOVEREIGN CATARACT EXTRACTION SYSTEM
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HQC·May 24, 2013
PARADIGM INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code LZG·September 30, 2014
REVEAL XT
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code DSI·June 16, 2011
UNKNOWN
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·July 26, 2024
ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·October 6, 2022
UNKNOWN
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·July 15, 2020
ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·February 9, 2023
ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·December 6, 2024
SLEEK OTW PTA CATHETER
FDA Adverse Event
Injury
·CLEARSTREAM TECHNOLOGIES LTD.·Product code DQY·December 13, 2023
WONDFO
FDA Adverse Event
Malfunction
·GUANGZHOU WONDFO BIOTECH CO., LTD.·Product code LCX·September 28, 2016
Single Shot Epidural Tray Catalog Number: 6183R1
FDA Enforcement
Class II
·Terminated·Busse Hospital Disposables, Inc.·June 8, 2022
Syngo.via picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 28, 2016