34 results
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30ms
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Sources: EU EUDAMED, US FDA
IMMUNOCAP RAPID INHALANT PROFILE , IMMUNOCAP RAPID READER, IMMUNOCAP RAPID READER CHECK DEVICE, AND IMMUNOCAP RAPID QC1
FDA 510(k)
FDA Class 2
·Immunology
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16740818300·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1674081830060·
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X0818300·8mm H x 18mm W x 30mm L x 0 degrees XLIF
ComfortGel
FDA UDI
Respironics, Inc.·00606959021051·
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587L081830120·8mm H x 18mm W x 30mm L XLIF Trial 12 degree Lo...
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X081830120·8mm H x 18mm W x 30mm L x 12 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X08183080·8mm H x 18mm W x 30mm L x 8 degrees XLIF
TRI-FIX SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
G7 NEUTRAL ARCOMXL LNR 36MM H
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code PBI·November 19, 2018
2520274-2013-11143
FDA Adverse Event
Malfunction
·SYNTHES (USA·Product code HWC·April 29, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 9, 2011
COROX OTW-S 85-BP
FDA Adverse Event
Injury
·BIOTRONIK GMBH AND CO.·Product code LWS·July 23, 2008
G7 PPS LTD ACET SHELL 62H
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PBI·June 26, 2018
G7 NEUTRAL ARCOMXL LINER
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PBI·March 27, 2018
G7 NEUTRAL ARCOMXL LNR 36MM H
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PBI·November 19, 2018
G7 NEUTRAL ARCOMXL LNR 36MM H
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PBI·November 19, 2018
G7 NEUTRAL E1 LINER
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PBI·March 27, 2018
SORIN BIOMEDICA SMARXT BCD VANGUARD
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTR·November 20, 2019