18 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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E-TYPE CONTRA ANGLE NAC-E
FDA 510(k)
FDA Class 1
·Dental
BA102
FDA Adverse Event
Malfunction
·NAKANISHI INC.·Product code EGS·March 31, 2016
BA105
FDA Adverse Event
Malfunction
·NAKANISHI INC.·Product code EGS·March 28, 2016
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EGS·August 29, 2017
VITROS
FDA UDI
ORTHO-CLINICAL DIAGNOSTICS, INC.·10758750005215·VITROS Chemistry Products TDM Performance Verif...
Sklar®
FDA UDI
SKLAR CORPORATION·50649111054967·STRABIS SCISS STR 4.5"STER 50
ENDOCLAMP AORTIC CATHETER
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code DXC·June 23, 2006
INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls
FDA 510(k)
FDA Class 2
·Hematology
NASOPORE EAR, MODELS ND04, ND05
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
Medical procedure kits labeled as: 1) ECONO STERILE STRABIS SCISS STR 4.5"STER 50, Model Number 96-2540; 2) ECONO STERILE STRABIS SCISS CVD 4.5"STER 50, Model Number 96-2541; 3) ECONO STERILE STRABIS SCISS STR 4.5"STER 25, Model Number 96-2542; 4) ECONO STERILE STRABISMUS SCISS STR4.5"CS/25, Model Number 96-2542M; eye surgery
FDA Enforcement
Class II
·Ongoing·Sklar Instruments·January 22, 2025
X-STOP INTERSPINOUS SPACER SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code NQO·February 14, 2013
45MM LFT NARROW MAND
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code LZD·January 18, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 29, 2014
CONTOUR ACETABULAR RECONSTRUCTION RING
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JDJ·June 6, 2025
MESH, SURGICAL, ACETABULAR, HIP, PROSTHESIS
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JDJ·January 23, 2026
CARTON LABEL: ''TDM Performance Verifier I''; 6 x 2 mL vials **** Catalog Number 896 2540 **** Made in USA by Ortho-Clinical Diagnostics , Inc., 100 Indigo Creek Drive, Rochester, NY 14626 ****
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·December 18, 2002
Depuy P.F.C. E Knee System, all polyethylene posterior-lipped tibial component, Sz 3, 8 mm; Ref 96-2540.
FDA Recall
Terminated
·Depuy Orthopaedics, Inc.·Product code NJL·May 26, 2005
Medical procedure kits labeled as: 1) ECONO STERILE STRABIS SCISS STR 4.5"STER 50, Model Number 96-2540; 2) ECONO STERILE STRABIS SCISS CVD 4.5"STER 50, Model Number 96-2541; 3) ECONO STERILE STRABIS SCISS STR 4.5"STER 25, Model Number 96-2542; 4) ECONO STERILE STRABISMUS SCISS STR4.5"CS/25, Model Number 96-2542M; eye surgery
FDA Recall
Open, Classified
·Sklar Instruments·Product code HNF·December 3, 2024