31 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RHAUSLER PLAGE ANTERIOR CERVICAL FUSION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3
FDA 510(k)
FDA Class 2
·Anesthesiology
STERILE POLYISOPRENE POWDER-FREE SURGICAL GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUG
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
COOK-SWARTZ DOPPLER PROBE
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code ITX·April 4, 2022
COOK-SWARTZ DOPPLER PROBE
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code ITX·February 22, 2022
COOK-SWARTZ DOPPLER PROBE
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code ITX·February 2, 2022
CADD SOLIS VIP PUMPS
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FRN·June 3, 2022
ELONGATED PECTUS STABILIZER
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HRS·May 14, 2013
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·September 23, 2014
LIGAMAX - CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·June 2, 2011
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
CADD-SOLIS VIP AMBULATORY INFUSION PUMP
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FRN·August 18, 2022
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
COOK-SWARTZ DOPPLER PROBE
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code ITX·November 23, 2022
ECHELON
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRA·July 25, 2025
MARATHON
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRA·July 25, 2025
ONYX
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3·Product code MFE·July 25, 2025
COOK-SWARTZ DOPPLER PROBE
FDA Adverse Event
Injury
·Product code ITX·May 25, 2021
COOK-SWARTZ DOPPLER PROBE
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code ITX·April 16, 2024
COOK-SWARTZ DOPPLER PROBE
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code ITX·April 2, 2024