16 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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BIOMET SPORTS MEDICINE ANCHOR DEVICES AND ZIPLOOP CONSTRUCTS
FDA 510(k)
FDA Class 2
·Orthopedic
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450322383·
Disposable Cuff
FDA UDI
SUNTECH MEDICAL, INC.·10840935104247·
REAL PATIENT AMBULATORY EEG, MODEL EX-AMB-RP (PROPOSED)
FDA 510(k)
FDA Class 2
·Neurology
MODIFICATION OF THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
22 G X 1.00 IN. BD INSYTE-W¿ PERIPHERAL VENOUS CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·September 8, 2017
BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·August 5, 2024
BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·December 8, 2023
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 26, 2013
4-WAY STOPCOCK WITH MALE LUER LOCK
FDA Adverse Event
Malfunction
·ARGON MEDICAL DEVICES, INC.·Product code DTL·April 6, 2011
COZMO INSULIN PUMP
FDA Adverse Event
Malfunction
·SMITHS MEDICAL MD (FORMERLY DELTEC, INC)·Product code LZG·July 17, 2008
BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·October 30, 2024
2.5 mm Reaming Rod W/Ball Tip 650 mm, Sterile
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·November 30, 2016
Instructions For Use document of the GPS Trackers.
FDA Enforcement
Class II
·Terminated·Blue Ortho·November 4, 2020
Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014