15 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
THROMBOLYTIC ASSESSMENT SYSTEM PROTHROMBIN TIME TEST CONTROLS
FDA 510(k)
FDA Class 2
·Hematology
VASOPRESS DVT SYSTEM, MODEL VP500D
FDA 510(k)
FDA Class 2
·Cardiovascular
Solana Influenza A+B Assay
FDA 510(k)
FDA Class 2
·Microbiology
BEHRING FIBRINTIMER A
FDA Adverse Event
Injury
·BEHRING DIAGNOSTIC, INC.·Product code GKT·July 1, 1997
MEON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·June 25, 2014
VITROS CHEMISTRY PRODUCTS PHBR SLIDES
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code DLZ·February 14, 2013
DYONICS INCISOR PLUS ELITE
FDA Adverse Event
Malfunction
·SMITH AND NEPHEW ENDOSCOPY, INC.·Product code HRX·December 28, 2010
VASOPRESS DIGITAL MINI PUMP
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL, INC.·Product code JOW·January 6, 2020
VASOPRESS DIGITAL MINI PUMP
FDA Adverse Event
Malfunction
·COMPRESSION THERAPY CONCEPTS, INC.·Product code JOW·February 18, 2020
VASOPRESS DIGITAL MINI PUMP
FDA Adverse Event
Malfunction
·COMPRESSION THERAPY CONCEPTS, INC.·Product code JOW·September 17, 2019
VASOPRESS DIGITAL MINI PUMP
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL, INC.·Product code JOW·November 19, 2019
VASOPRESS DIGITAL MINI PUMP
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL, INC.·Product code JOW·November 19, 2019
VASOPRESS DIGITAL MINI PUMP
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL, INC.·Product code JOW·December 10, 2019
Medtronic INTREPID Spinal System SPACER, 32X23, 8 DEG, Size: 10MM, Part Number: REF 7961810; 12MM, REF 7961812; 14MM, REF 7961814; 16MM, REF 7961816; 18MM, REF 7961818; 20MM, REF 7961820; Rx only, STERILE R. The INTREPID Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease.
FDA Recall
Terminated
·Medtronic Sofamor Danek USA Inc·Product code MAX·February 6, 2009
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