24 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
OsteoMed
FDA UDI
OSTEOMED LLC·00845694032698·FPS .189 x 9" Smooth Steinman Pin
GUMS SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896083677·GUMS SCISSORS SHARP CURVED BLADE POWER CUT GOLD
NA
FDA UDI
Biedermann Motech GmbH & Co. KG·04250869691994·MOSS VRS/MIS Locking Instrument
OsteoMed
FDA UDI
OSTEOMED LLC·00845694073066·FPS .189 x 9" Smooth Steinman Pin Sterile Qty 2
LIFESTYLES, CONTEMPO OR PRIVATE LABEL STRAWBERRY, VANILLA, OR BANANA FLAVORED CONDOM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SYSTEM 2000 CONTROLLER, SYSTEM 5000 CONTROLLER, FOOTSWITCH, POWER CORD, AND VISAGE WANDSFF
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DS2ADV AUTO CPAP
FDA Adverse Event
Injury
·RESPIRONICS, INC.·Product code BZD·May 27, 2024
DREAMSTATION 2 ADV AUTO CPAP
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·March 3, 2025
DS2ADV AUTO CPAP
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·October 8, 2024
DS2ADV AUTO CPAP
FDA Adverse Event
Injury
·RESPIRONICS, INC.·Product code BZD·July 30, 2024
COLLEAGUE 3 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 20, 2008
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 11, 2011
UNKNOWN NEUROSTIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LGW·July 1, 2013
BD LUER-LOK
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·December 19, 2024
FREEDOM NEUROSTIMULATOR
FDA Adverse Event
Injury
·STIMWAVE TECHNOLOGIES INC·Product code GZB·December 24, 2020
DiaSorin 25-HydroxyvitaminD [125I] RIA Kit. For the quantitative determination of 25-OH-D and other hydroxylated metabolites in serum or plasma. REF: 68100E. DiaSorin Stillwater, Minnesota 55082-0285, U.S.A., Lot # 113300B.
FDA Recall
Terminated
·Diasorin Inc.·Product code LCI·June 30, 2004
Olympus Sterile Optical Laser Fiber, single use and reusable
FDA Enforcement
Class II
·Terminated·Quanta System, S.p.A.·June 16, 2021
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 200 MM, Silicone, Sterile, Item 431196.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.
FDA Enforcement
Class II
·Terminated·Bayer Corp·June 11, 2014