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

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PRELUDE SHEATH INTRODUCER

FDA 510(k)
FDA Class 2 ·Cardiovascular

TruForm

FDA UDI
Rmo, Inc.·00885797099716·MD MLR BDS R/L SE ASIA ASST100

Paltop

FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108699692·Manual Hex Driver Ø1.25mm L23mm, Long

DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS

FDA 510(k)
FDA Class 2 ·Microbiology

AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO

FDA 510(k)
FDA Class 2 ·Radiology

SPECTRA WAVEWRITER

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 4, 2024

PRECISION? MONTAGE? MRI

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·May 1, 2025

OMNIGUIDE BEAMPATH FIBER AND ADAPTER

FDA Adverse Event
OMNIGUIDE, INC.·Product code GEX·October 19, 2010

ASR TAP SLV ADAP 12/14 -1

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL LTD.·Product code KWA·March 17, 2016

PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·April 15, 2013

RESTORE PRIME ADVANCED

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·April 25, 2011

COAGUCHEK S SYSTEM

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JPA·July 3, 2008

Welch Allyn Vital Signs Monitor 5300 Series 300 Part numbers 007-0098-00 through 007-0159-00

FDA Recall
Terminated ·Welch Allyn Protocol, Inc·Product code DQA·June 8, 2004

CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024