11 results · 20ms · Sources: EU EUDAMED, US FDA

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ELECTROSURGICAL AND ARTHROSCOPY ACCESSORY ELECTRODES

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Freedom Syringe

FDA 510(k)
FDA Class 2 ·General Hospital

COMBI SCAN 500 URINE TEST STRIP ANALYZER, MODEL A93005

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

NOVOPEN 3

FDA Adverse Event
Injury ·NOVO NORDISK A/S, MEDICAL SYSTEMS·Product code FMF·March 28, 2007

PRECISION QID

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC·Product code NBW·January 26, 2017

PRECISION XTRA

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC·Product code NBW·January 26, 2017

O2 OPTIX

FDA Adverse Event
Injury ·PT CIBA VISION BATAM·Product code LPM·June 19, 2014

VITROS CHEMISTRY PRODUCTS PHBR SLIDES

FDA Adverse Event
Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code DLZ·February 14, 2013

AUTOMATED PD SET W/CASSETTE4 PRONG

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·January 14, 2011

Selectra ProS Analyzer, Catalog # 6003-600/UDI # 03661540600418 Product Usage: :clinical chemistry system intended for use in clinical laboratories.

FDA Enforcement
Class II ·Terminated·Vital Scientific N.V.·October 23, 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