18 results · 21ms · Sources: EU EUDAMED, 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