11 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ENDOSCOPIC ULTRASOUND CENTER EU-Y0008
FDA 510(k)
FDA Class 2
·Radiology
OsteoMed
FDA UDI
OSTEOMED LLC·00845694003315·1.6mm Pre-bent Plate, 12mm step, Left
OsteoMed
FDA UDI
OSTEOMED LLC·00845694064217·1.6 OSA 12mm Pre-bent Left Plate Sterile Qty 2
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
FDA 510(k)
FDA Class 1
·General Hospital
EARLYDETECT MENOPAUSE TEST FOR FSH
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BAROUK SCREW - 3 0MM X 32MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HWC·April 7, 2020
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 24, 2013
OSCILL-SAW-ATTACHM W/QUICK-COUPL F/COMPA
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code GFA·September 30, 2014
CAPSUREFIX NOVUS MRI
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code NVN·June 16, 2011
syngo.CT VA20A, VA30A and VA40A in: syngo.via RT Image Suite / Sim&Go SOMATOM go.Now SOMATOM go.Up SOMATOM go.All SOMATOM go.Top SOMATOM go.Sim SOMATOM go.Open Pro and SOMATOM X.cite Material Numbers: 11061620 11061628 11061630 11061640 11061660 11061670
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·September 22, 2021
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