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

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DURHAM; ADM. SET-LUER LOCK W/.22 MICRON FILTER

FDA 510(k)
FDA Class 2 ·General Hospital

ORTHO

FDA UDI
ORTHO-CLINICAL DIAGNOSTICS, INC.·10758750005277·ORTHO® HCV Version 3.0 ELISA Test System

Barco

FDA UDI
Barco NV·05415334002012·MDSC-2324 LED

BOSS Instruments

FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515239630·Joseph Nasal Knife, str, 24mm, pt, dbl edge, sm bl

RHYTHMIA MAPPING SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

OSSIOfiber® Cannulated Trimmable Fixation Nail

FDA 510(k)
FDA Class 2 ·Orthopedic

Compress Device Short Anchor Plug, 16 MM- Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement Item Number: 178558

FDA Enforcement
Class II ·Ongoing·Biomet, Inc.·November 29, 2023

INTELLAMAP ORION¿

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code DRF·February 18, 2016

ACCU-CHEK ® AVIVA TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·December 16, 2010

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 28, 2013

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 12, 2014

BW Lasso 2515 ANV eco Variable Diagnostic EP Catheter, REF D134301 Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation.

FDA Enforcement
Class II ·Terminated·Stryker Sustainability Solutions·January 30, 2019