19 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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25OH VITAMIN D TOTAL ELISA TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CoRoent
FDA UDI
Nuvasive, Inc.·00887517574473·CoRoent Ant TLIF Ti, 12x13x36mm 4°
ArgenZ ST 98x14 ML C3
FDA UDI
ARGEN CORPORATION, THE·D818123364·Dental porcelain/ceramic restoration kit
Paxeon Logical
FDA UDI
PAXEON RECONSTRUCTION LLC·08177570201327·Logical G-Series Shell – 3 Holes Size 64-E
Logical G-Series Acetabular Shell
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215052188·
Logical G-Series
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215000936·
SCREW,FIXATION,BONE
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HWC·June 9, 2017
OrthoMedFlex
FDA UDI
ORTHOMEDFLEX LLC·M7161111233640·64mm Acetabular Cup (3-hole)
BD ULTRA FINE¿ PEN NEEDLE
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FMI·September 18, 2019
MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, LEVEL 2, DUAL LEVEL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
2.7MM LCP ULNA OSTEOTOMY SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
VENTO Cup
FDA UDI
AMPLITUDE SAS·03701089514118·
OT VERIO TEST STRIPS
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 21, 2013
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC·Product code GJS·June 10, 2011
VERSACARE BED
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 20, 2008
SENSITHERM PROBE
FDA Adverse Event
Injury
·FIAB S.P.A.·Product code FLL·July 10, 2023
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES SELZACH·Product code HWC·June 2, 2015
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES SELZACH·Product code HWC·June 3, 2015
Synchro .014"guide wire, 35 cm tip, Catalog: M00313010 Synchro .014 guide wire, 300 cm length, Catalog: M00313310 SYNCHRO .010 WIRE SOFT STRAIGHT 200cm, Catalog: M00316310 SYNCHRO .010 WIRE SOFT STRAIGHT 300cm, Catalog: M00316330
FDA Enforcement
Class II
·Ongoing·Stryker Neurovascular·June 5, 2024