14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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