12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VITALSTIM EXPERIA
FDA 510(k)
FDA Class 2
·Physical Medicine
Kalitec Universal Instruments
FDA UDI
Kalitec Direct LLC·B07301K0604250·Tray, Base, 4.25"
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197541237·RZ Tebbet Breast Retractor
70x25m...
DRACO
FDA UDI
HNM TOTAL RECON LLC·00841742121970·DRACO MetaFuse U Midfoot/Lisfranc Plate, Ti - (...
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 21, 2023
EPIDURAL CATHETER WITH CONNECTOR (AND ACCESSORY)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ISOBAR SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SELUTE PICOTIP
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVN·April 22, 2013
RENAISSANCE 26 STRETCHER
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·March 29, 2011
LEAD MODEL 302
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code MUZ·July 3, 2008
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 ( 21-2120 , 21-2125 , and 21-2127 ) 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
Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
FDA Enforcement
Class I
·Ongoing·Datex-Ohmeda, Inc.·October 30, 2024