15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Soft Plug Extended Duration 180 Canalicular Plug
FDA 510(k)
FDA Unclassified
·Unknown
BI-METRIC REVISION HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304252264·
Bi-Metric® Revision Hip System
FDA UDI
Biomet Orthopedics, LLC·00887868261503·
BI-METRIC(R) HEAD/NECK PROVISIONAL
FDA UDI
Biomet Orthopedics, LLC·00880304307537·
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·October 20, 2023
ZIP'R4/ ZIP'R4 XTRA SCOOTER
FDA 510(k)
FDA Class 2
·Physical Medicine
INNOVACON HCG UKTRA TEST DEVICE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CONSULT HCG TEST
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code JHI·March 4, 2025
AMISTEM C, CEMENTED STEM SIZE 4 STD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·December 7, 2016
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 14, 2011
GYNECARE MORCELLEX* TISSUE MORCELLATOR
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code HET·June 11, 2013
ONE TOUCH ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·September 9, 2008
CONSULT HCG URINE CASSETTE 5001 25T
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code JHI·September 9, 2019
PEDICLE SCREW LATERAL CONNECTOR L150
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·December 13, 2023
OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021