11 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACTIV VARNISH
FDA 510(k)
FDA Class 2
·Dental
n/a
FDA UDI
HANS RUDOLPH, INC.·00874750007110·3830B PNT/HTRSHELL/CONN ASSY
LGN PS HIGH FLEX XLPE SZ 1-2 13MM
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·August 9, 2017
CORELEADER COLLA-PAD MODEL CS 03030
FDA 510(k)
FDA Unclassified
·Unknown
SUNLITELED MODEL #2810
FDA 510(k)
FDA Class 2
·Dental
LGN PS HIGH FLEX XLPE SZ 1-2 13MM
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·August 9, 2017
RECONSTRUCTION NAIL R2.0, TI, LEFT T2 RECON Ø11X360 MM X 125°
FDA Adverse Event
Injury
·STRYKER TRAUMA KIEL·Product code HSB·July 23, 2018
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 14, 2013
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 3, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 15, 2008
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