29 results · 22ms · Sources: EU EUDAMED, US FDA

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WAVEON FRACTURE REPAIR SYSTEM (WAVEON RX)

FDA 510(k)
FDA Class 2 ·Orthopedic

Bard® Blakemore Esophageal-Nasogastric Tube

FDA UDI
C. R. Bard, Inc.·00801741076817·Bard® Blakemore Esophageal-Nasogastric Tube

Medtronic Reusable Instruments

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00673978959139·DISTRACTOR 9092110 STRGHT HOUSING 10MM

GALILEO® CRT²™ LAG SCREW, RIGHT, 10.5mm x 110mm

FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665036732·

APEX Knee System

FDA UDI
Omni Life Science, Inc.·00841690198413·AK3 Ultra Insert Trial Size 1, 10mm

SPL CRIMP SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

DRI ECSTASY ENZYME IMMUNOASSAY

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

SLEEPEASY

FDA Adverse Event
Injury ·RESPIRONICS INC.·Product code BZD·April 12, 2012

REMSTAR PLUS M-SERIES

FDA Adverse Event
Malfunction ·RESPIRONICS INC.·Product code BZD·May 6, 2010

REMSTAR M SERIES

FDA Adverse Event
Malfunction ·RESPIRONICS INC.·Product code BZD·November 25, 2009

M-SERIES DC POWER SUPPLY

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·May 25, 2012

BARD® BLAKEMORE ESOPHAGEAL-NASOGASTRIC TUBE

FDA Adverse Event
Malfunction ·C.R. BARD INC. (COVINGTON) -1018233·Product code KNT·January 23, 2026

BARD® BLAKEMORE ESOPHAGEAL-NASOGASTRIC TUBE

FDA Adverse Event
Malfunction ·C.R. BARD INC. (COVINGTON) -1018233·Product code KNT·January 13, 2026

Bard Blakemore Esophageal-Nasogastric Tube (Child) REF: 0092110

FDA Recall
Open, Classified ·C.R. Bard Inc·Product code KNT·April 17, 2025

RIATA ACTIVE FIXATION LEAD

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D·Product code NVY·January 13, 2014

ENDURANT

FDA Adverse Event
Death ·MEDTRONIC CARDIOVASCULAR SANTA ROSA·Product code MIH·May 3, 2013

GREENLIGHT ADDSTAT

FDA Adverse Event
Malfunction ·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·April 27, 2011

Bard¿ Blakemore Esophageal-Nasogastric Tube (Child) REF: 0092110

FDA Enforcement
Class I ·Ongoing·C.R. Bard Inc·May 28, 2025

REMSTAR PLUS M-SERIES

FDA Adverse Event
Death ·RESPIRONICS, INC.·Product code BZD·March 16, 2012

REMSTAR M SERIES

FDA Adverse Event
Malfunction ·RESPIRONICS INC·Product code BZD·February 24, 2010