22 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TRI-FIT FEMORAL STEM
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526743519·LEVAMED ANKLE SUPPORT SILVER III
Medallion®
FDA UDI
Merit Medical Systems, Inc.·00884450021712·
neoWave LS
FDA UDI
XENIX MEDICAL LLC·00818345023963·PADDLE SPREADER, 13MM
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0102130·Shaver, Open 13mm
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033119570·
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0100430·Caddie Lid, Adjustable Cross Links
MINIMED MIO ADVANCE
FDA Adverse Event
Injury
·UNOMEDICAL A/S·Product code FPA·July 29, 2025
MINIMED MIO ADVANCE
FDA Adverse Event
Injury
·UNOMEDICAL A/S·Product code FPA·September 23, 2025
DORNIER MEDILAS H
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ACCU-PULSE TENS UNIT
FDA 510(k)
FDA Class 2
·Neurology
MINIMED MIO ADVANCE
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 27, 2025
BATT-HANDPIECE MOD F/TRS
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code GEY·March 19, 2013
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·March 1, 2011
ANGIO-SEAL
FDA Adverse Event
Injury
·ST JUDE MEDICAL·Product code MGB·March 8, 2008
GAIA FIRST
FDA Adverse Event
Injury
·ASAHI INTECC CO., LTD.·Product code DQX·March 31, 2023
ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·June 30, 2025
Stryker Instruments 0400-850-000 T4 Toga, Zipper, (XL-Tall) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.
FDA Enforcement
Class II
·Terminated·Stryker Instruments Div. of Stryker Corporation·June 12, 2013
Stryker Instruments 0400-820-000 T4 Zipper Toga (L/XL) Sterile, O; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.
FDA Enforcement
Class II
·Terminated·Stryker Instruments Div. of Stryker Corporation·June 12, 2013
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·June 29, 2022