12 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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Genesys Spine Apache Interbody Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
Novo Surgical
FDA UDI
NOVO SURGICAL, INC.·G586G1716560·tissue forceps, standard pattern, serrated hand...
BD ULTRA FINE¿ PEN NEEDLES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND CO.·Product code FMI·May 2, 2019
GEMINI LITHOTRIPTER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SBI ARTFIX
FDA 510(k)
FDA Class 2
·Orthopedic
TROCHANTERIC NAIL KIT, TI GAMMA3 10X170MM X 125
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·September 14, 2012
APEX HOLE ELIM POSITIVE STOP
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·October 14, 2014
DHS/DCS-SCR Ø12.5 L105 SST
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code KTT·June 15, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 21, 2011
ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH)
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·December 10, 2020
CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L e. 21-2120-0105-08L f. 21-2120-0105-12L g. 21-2120-0105-13L h. 21-2120-0105-14L i. 21-2120-0105-15L j. 21-2120-0105-17L k. 21-2120-0105-50L l. 21-2127-0105-02L m. 21-2127-0105-06L n. 21-2127-0105-50L
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD Inc.·October 27, 2021
Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781342 781377
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021