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

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PK Lap Loop

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772814220·GENUMEDI PT SILVER L V

LEONE SPA

FDA UDI
LEONE SPA·08033707011477·CALIBRA 1ST MOL BANDS W/G8025-02 n.UR 25

Vilex Power Accessory

FDA UDI
VILEX IN TENNESSEE, INC.·00841731122247·KWire .054x9" (1.4x225mm)

PIPELINE

FDA UDI
Micro Therapeutics, Inc.·00847536009318·FA-71425-25 PIPELINE EMB DEVICE

PIPELINE

FDA UDI
Micro Therapeutics, Inc.·00847536009332·FA-71425-25 PIPELINE EMB DEVICE

Pipeline

FDA UDI
Micro Therapeutics, Inc.·00836462014893·Embolization Device

BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S)

FDA 510(k)
FDA Class 2 ·Anesthesiology

CENTRICITY RADIOLOGY RA600/CENTRICITY CARDIOLOGY CA1000/CENTRICITY DIGITAL HARDCOPY WORKSTATION

FDA 510(k)
FDA Class 2 ·Radiology

PIPELINE EMBOLIZATION DEVICE

FDA Adverse Event
Injury ·EV3 NEUROVASCULAR·Product code OUT·September 13, 2012

LINEAR ST

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 12, 2024

ECHI GREENVILLE NC 2

FDA Adverse Event
Other ·SORIN GROUP USA, INC.·Product code DTZ·November 22, 2011

ECHI GREENVILLE NC 2

FDA Adverse Event
Other ·SORIN GROUP USA, INC.·Product code DTZ·November 30, 2011

STONYBROOK HSP NY NY 1

FDA Adverse Event
Other ·SORIN GROUP USA, INC.·Product code OEZ·September 15, 2015

PELVICOL ACELLULAR COLLAGEN MATRIX

FDA Adverse Event
Injury ·TISSUE SCIENCE LABORATORIES·Product code FTL·April 25, 2013

9681707-2011-00002

FDA Adverse Event
Injury ·Product code ELW·June 2, 2011

VERSACARE

FDA Adverse Event
Malfunction ·HILL-ROM RITTER·Product code FNL·September 3, 2008

MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

FDA Recall
Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

PIPELINE EMBOLIZATION DEVICE

FDA Adverse Event
Injury ·EV3 NEUROVASCULAR·Product code OUT·March 5, 2013

C21785 IT TREVISO

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA·Product code GEI·December 14, 2012