16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ANAXBLEND MODEL 20XXX (SEVERAL), ANAXGUM MODEL 25XXX (U), MOCK-UP DIRECT MODEL 240XXX (U), MOCK-UP DIRECT FLOW MODEL 24A
FDA 510(k)
FDA Class 2
·Dental
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017705·K-Wire, Double Ended, Trocar Point, Diameter Si...
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017712·K-Wire, Double Ended, Trocar Point, Diameter Si...
Marker Pin Inserter
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215068608·
ELECSYS DIGOXIN CALCHECK 5
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BI-PHASIC INFILTRATOR
FDA 510(k)
FDA Class 2
·General Hospital
ZIMMER SKIN GRAFT MESHER
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL, INC.·Product code FWZ·November 19, 2019
BD PLASTIPAK¿ SYRINGES
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·October 29, 2022
INFINITI VISION SYSTEM OZIL
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·May 7, 2013
EBI MODEL 10D
FDA Adverse Event
Injury
·EBI, LLC·Product code ILO·June 2, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 15, 2008
ZYSTON IMPLANT, UNKNOWN SIZE OR TYPE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code MAX·August 22, 2020
ZYSTON IMPLANT, UNKNOWN SIZE OR TYPE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code MAX·August 22, 2020
BD LUER-LOK¿ TIP SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·December 29, 2021
50 ML BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·March 21, 2022
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021