9 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EXACTECH ALL POLY ACETABULAR CUP
FDA 510(k)
FDA Class 2
·Orthopedic
SIGMA
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295246077·SIGMA TC3 RP INSERT TRIAL SIZE 1.5 15mm
ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor
FDA 510(k)
FDA Class 2
·Radiology
FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (3.5 MM TO 5.5 MM)
FDA 510(k)
FDA Class 2
·Cardiovascular
DC PLUM W/SEC CONVPN (48/CASE)
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·June 19, 2014
SUMMIT POR TAPER SZ5 STD OFF
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LPH·February 15, 2013
L9000 LIGHTSOURCE
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY SAN JOSE·Product code FCW·January 6, 2011
HEARTWARE VENTRICULAR ASSIST SYSTEM - SHOULDER PACK
FDA Adverse Event
Malfunction
·HEARTWARE, INC.·Product code DSQ·January 7, 2025
Model 055: Thermophore Classic, Professional Quality, Deep-Heat Therapy, Model 055 Large 14' x 27", Model 056: Thermophore Classic, Professional Quality Deep-Heat Therapy, Model 056 Medium 14" x 14", Model 077: Thermophore Classic Professional Quality Deep-Heat Therapy, Model 077 Petite 4"x 17",Model 095: Thermophore Classic, Professional Quality Deep-Heat Therapy, Model 095 Large 14" x 27 Model 096: Thermophore Classic, Professional Quality Deep-Heat therapy Model 096, Medium, 14" x 14" Model 097: Thermophore Classic, Professional quality Deep-Heat Therapy, Model 097 , Petite, 4" x 17", Model 255: Thermophore Classic Plus, Professional Quality Deep-Heat Therapy, Model 255 Large,14" x 27", Model 256: Thermophore Classic Plus Professional Quality Deep-Heat Therapy, Model 256, Medium, 14" X 14 Model 277: Thermophore Classic Plus Professional Quality Deep-Heat Therapy, Model 277, Petite , 4" x 17" Used for the temporary relief of joint and muscle pain.
FDA Enforcement
Class II
·Terminated·Battle Creek Equipment Co.·November 9, 2016