163 results · 30ms · Sources: EU EUDAMED, US FDA

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Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter

FDA 510(k)
FDA Class 2 ·Cardiovascular

MSI Precision Specialty Instruments

FDA UDI
Med Saver, Inc.·00194613106379·Slit Blade, Angled, 3.2mm Blade, Screw-In Tip, ...

BELLA

FDA 510(k)
FDA Class 2 ·Radiology

QUICKDRAW CONVERTIBLE FIXATION IMPLANT SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

NMIC-312

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·January 16, 2026

ALTRUA

FDA Adverse Event
Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·July 23, 2011

ALTRX NEUT 32IDX52OD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC./REG. #1818910·Product code LPH·June 17, 2013

SYMBIQ DCHANNEL 3.01

FDA Adverse Event
Malfunction ·HOSPIRA HOLDINGS DE COSTA RICA LTD.·Product code FRN·October 10, 2014

PANEL PHOENIX NMIC-312

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 3, 2026

PANEL PHOENIX NMIC-312

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 23, 2026

PANEL PHOENIX NMIC-312

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 19, 2026

PANEL PHOENIX NMIC-312

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 19, 2026

PANEL PHOENIX NMIC-312

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 19, 2026

PANEL PHOENIX NMIC-312

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 19, 2026

PANEL PHOENIX NMIC-312

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 19, 2026

RaPET¿ RF Latex Reagent used as a component in the following kits: RaPET RF (1155-100, Control# 173201 expiry 2019-04-30) RF Latex (1156-001, Control# 172224 expiry 2019-12-31) RF Latex (1155L-100B, Control # 172701 expiry 2019-09-30 and Control # 173262 expiry 2019-12-31) Product Usage: RaPET¿ RF is intended for the qualitative and semiquantitative detection of rhematoid factor in human serum. The latex slide test is intended to be used as an aid in the diagnosis of rheumatoid arthritis.

FDA Enforcement
Class II ·Terminated·Stanbio Laboratory, LP·March 21, 2018

PANEL PHOENIX NMIC-312

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 19, 2026

PANEL PHOENIX NMIC-312

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 19, 2026

PANEL PHOENIX NMIC-312

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 19, 2026

RaPET RF Latex Reagent used as a component in the following kits: RaPET RF (1155-100, Control# 173201 expiry 2019-04-30) RF Latex (1156-001, Control# 172224 expiry 2019-12-31) RF Latex (1155L-100B, Control # 172701 expiry 2019-09-30 and Control # 173262 expiry 2019-12-31) Product Usage: RaPET RF is intended for the qualitative and semiquantitative detection of rhematoid factor in human serum. The latex slide test is intended to be used as an aid in the diagnosis of rheumatoid arthritis.

FDA Recall
Terminated ·Product code DHR·February 13, 2018