17 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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CENTRIFUGAL PUMP
FDA 510(k)
FDA Class 2
·Cardiovascular
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040012376·Zirlux 16+ 0M3 95X22
PROGRESS
FDA UDI
ABBOTT VASCULAR INC.·08717648144103·HI-TORQUE PROGRESS 80 Guide Wire .014 Straight ...
Henry Schein Cover Film
FDA UDI
HENRY SCHEIN, INC.·00304040003923·Cover film Blue
Phonak
FDA UDI
Phonak AG·07613275080726·Phonak Bolero Q70-P (purple transparent)
TAPER-LOCK DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
FOX PTA CATHETER, 3.0, 4.0, 5.0, 6.0, 7.0, AND 8.0 X 40 MM, MODELS A14003, A14004, A14005, A14006, A14007, A14008
FDA 510(k)
FDA Class 2
·Cardiovascular
SCR REPLACEMENT SW-V GOLD COPING
FDA Adverse Event
Malfunction
·ZIMMER DENTAL·Product code DZE·October 19, 2017
SCR FIXATION REPLACE SPEC TRA-CONE & TAPERED ABU
FDA Adverse Event
Malfunction
·ZIMMER DENTAL·Product code DZE·December 8, 2020
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 19, 2013
ACRYSOF IQ TORIC
FDA Adverse Event
Other
·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·February 25, 2011
9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC·Product code JAA·March 11, 2008
BD Interlink threaded lock cannula This is a locking blunt plastic cannula specifically designed for IV connection to an Interlink¿ injection site. It is screwed down over the Interlink¿ injection site and a blunt plastic cannula inside the housing enters the Interlink¿ injection site to provide a pathway for IV fluid administration.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·January 22, 2014
Stopcock rotator (Component): a. 1050 STOPCOCK ROTATOR, OFF HANDLE, Model Number MX1431MR b. 1050 STOPCOCK LEFT ROTATOR, OFF HANDLE, Model Number MX1431MRL c. 700 PSI STPCK W/ ROTATOR, Model Number MX4331R. Stopcocks and manifolds used to control the direction of IV fluid flow.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·April 28, 2021
Oxford Femoral Knee System REF 154600, LOT 2272736, WARNING DO NOT RESTERILIZE, STERILE UNLESS PACK DAMAGED, BIOMET UK Ltd, (510K# K011138) This device is used in partial knee replacement surgery as a result of patients who are experiencing degenerative arthritis.
FDA Recall
Terminated
·Product code HRY·April 22, 2011
UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
FDA Enforcement
Class II
·Terminated·Unomedical As·July 1, 2015