12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ENDOFAST RELIANT SCP, ENDOFAST RELIANT LAP
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
OsteoMed
FDA UDI
OSTEOMED LLC·00845694003322·1.6mm Pre-bent Plate, 12mm step, Right
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172971185·
OsteoMed
FDA UDI
OSTEOMED LLC·00845694064231·1.6 OSA 12mm Pre-bent Right Plate Sterile Qty 2
PORTABLE RO+ MODEL MROS09
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE)
FDA 510(k)
FDA Class 1
·General Hospital
VENTRICULAR CATHETERS
FDA Adverse Event
Death
·INTEGRA NEUROSCIENCES IMPLANTS S.A.·Product code JXG·June 28, 2013
PFC*SIGMA A/P CVD TB10MM,SZ 3
FDA Adverse Event
Injury
·8010379 DEPUY INTL., LTD.·Product code JWH·May 24, 2013
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·September 30, 2014
CAPSUREFIX NOVUS MRI
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code NVN·June 16, 2011
SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670 & 11061678 SOMATOM X.cite 11330001 Intended Use: Computed tomography x-ray system
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022
Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare Inc·May 13, 2015