37 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MDRIVE
FDA 510(k)
FDA Class 2
·Anesthesiology
MAXCUT CARBIDE BUR (10/pk) FGSU # 702
FDA UDI
SCOTT'S DENTAL SUPPLY L.L.C.·D77811117421·MAXCUT CARBIDE BUR (10/pk) Shape: Round; Size: ...
ONESTEP ADULT MULTI-FUNCTION ELECTRODE
FDA 510(k)
FDA Class 3
·Cardiovascular
THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·October 29, 2015
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code NKB·June 11, 2014
SIMPLEX P-JAPANESE TWIN PACK
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code LOD·May 14, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 2, 2011
MIRAGE .008 HYDROPHILIC GUIDEWIRE
FDA Adverse Event
Injury
·EV3 NEUROVASCULAR·Product code DQX·August 13, 2008
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·May 25, 2018
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·May 25, 2018
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·December 22, 2017
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code NKB·May 6, 2022
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code NKB·May 6, 2022
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
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·December 22, 2017
CD HORIZON - CHROMALOY PLUS ROD
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·July 22, 2020
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·July 4, 2025
CONTOUR® NEXT
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code JJX·September 4, 2025
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