18 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Vitrification Kit and Thawing Kit
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Key Surgical K-Wires and Steinmann Pins
FDA UDI
KEY SURGICAL, INC.·00849771015482·Steinmann Pins, Double diamond, threaded, .177-...
NA
FDA UDI
KEY SURGICAL, INC.·10849771050138·Steinmann Pins, Double diamond, threaded, .177-...
SOLID CANCELLOUS LAG SCREW
FDA UDI
Biomet Orthopedics, LLC·00887868005183·
THE POWERWAND SAFETY INTRODUCER WITH AND EXTENDED DWELL
FDA 510(k)
FDA Class 2
·Cardiovascular
RECOVERY+ MODEL PS 511, DVTHERAPY MODEL PS 511A
FDA 510(k)
FDA Class 2
·Cardiovascular
ACCU-CHEK ® MOBILE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·October 15, 2014
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·July 22, 2011
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 17, 2013
M.U.S.T. MIDLINE CORTICAL (MC) SCREW SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·October 4, 2024
PEDICLE SCREW MUST COMBINED SETSCREW H4-T27 - (4X)
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code NKB·October 9, 2019
UNKNOWN
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·July 26, 2024
ROADRUNNER EXTRA-SUPPORT BARE MANDRIL WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·January 19, 2021
PEDICLE SCREW 6X45
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code KWP·July 5, 2019
UNKNOWN HIP FEMORAL STEM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·October 11, 2019
UNKNOWN HIP ACETABULAR LINERS
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWZ·October 11, 2019
UNKNOWN HIP FEMORAL HEAD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·October 11, 2019
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