19 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CORIN TRINITY ACETBULAR SYSTEM WITH HXLPE LINERS
FDA 510(k)
FDA Class 2
·Orthopedic
7D Surgical Facet Array Adaptor
FDA UDI
7D Surgical ULC·00628341520720·
Leva® Anterior Interbody System
FDA UDI
Spine Wave, Inc.·10840642109061·Modular Spacer, 38 mm (W) x 30 mm (L) x 17 mm (...
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K1100070·Tray Insert 1, NIDO
XLTEK REAL PATIENT EVOKED POTENTIAL HEADBOX, MODEL EP-16-RP
FDA 510(k)
FDA Class 2
·Neurology
REPROCESSED RESTEP COMPRESSION SLEEVES
FDA 510(k)
FDA Class 2
·Cardiovascular
RESPIRONICS
FDA Adverse Event
Malfunction
·Product code MNT·April 8, 2021
PALAXPRESS, CLEAR, 1000G POWDER
FDA Adverse Event
Injury
·HERAEUS KULZER GMBH & CO. KG, MEDICAL DIVISION·Product code EBI·February 1, 2012
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·May 13, 2013
L-CATH PICC
FDA Adverse Event
Other
·ARGON MEDICAL DEVICES, INC.·Product code LJS·May 20, 2011
GE OEC 9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS, INC.·Product code JAA·August 14, 2008
BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·November 26, 2018
Video Duodenoscope
FDA Enforcement
Class II
·Terminated·Pentax Medical Company·June 8, 2016
EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.
FDA Enforcement
Class II
·Terminated·Pentax Medical Company·July 30, 2014
Syringes with exchangeable needles labeled as: SOL-CARE: 1) SOL-CARE 10ml Luer Lock Syringe w/Safety Needle 21G*1 1/2 (needle aside), Model No. 102115SN, UPC 818392019858; 2) SOL-CARE 10ml Luer Lock Syringe w/Safety Needle 22G*1 1/2 (needle aside), Model No. 102215SN, UPC 818392019865; 3) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 25G*1 (needle aside), Model No. 12510SN, UPC 818392018851; 4) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 25G*5/8 (needle aside), Model No. 12558SN, UPC 818392018950; 5) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 27G*1/2 (needle aside), Model No. 12705SN, UPC 818392018967; 6) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 30G*1/2 (needle aside), Model No. 13005SN, UPC 818392018974; 7) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 21G*1 (needle aside), Model No. 32110SN, UPC 818392019001; 8) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 21G*1 1/2 (needle aside), Model No. 32115SN, UPC 818392019018; 9) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 22G*1 (needle aside), Model No. 32210SN, UPC 818392019025; 10) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 22G*1 1/2 (needle aside), Model No. 32215SN, UPC 818392019032; 11) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 23G*1 (needle aside), Model No. 32310SN, UPC 818392019049; 12) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 25G*1 (needle aside), Model No. 32510SN, UPC 818392019063; 13) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 25G*5/8 (needle aside), Model
FDA Enforcement
Class II
·Ongoing·Sol-Millennium Medical Inc.·September 18, 2024
Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·January 24, 2024
Spectral CT. Computed tomography X-ray system.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 2, 2025
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024