15 results
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33ms
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Sources: EU EUDAMED, US FDA
ACCULAB SUPPLIES CHEMICAL ANALYZERS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PHB, Autoalert, Japan - Primary
FDA UDI
Lifeline Systems Company·00884838071797·PHB, Autoalert, Japan - Primary
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78405011·Micro Sprint Bracket Roth .022" max. 4+5 right
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78405011001·Micro Sprint Bracket Roth .022" max. 4+5 right
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78405010051·Micro Sprint Bracket Roth .022" max. 4+5 right
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78405010101·Micro Sprint Bracket Roth .022" max. 4+5 right
VertebraLINK
FDA UDI
LINKSPINE, INC.·00817329023500·TLIF Tamp - Straight
VertebraLINK
FDA UDI
LINKSPINE, INC.·00817329023517·TLIF Tamp - Angled
DBX DEMINERALIZED BONE MATRIX PUTTY, PASTE AND MIX
FDA 510(k)
FDA Class 2
·Dental
XENMATRIX SURGICAL GRAFT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·May 30, 2014
TURBO-JECT DOUBLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER TRAY
FDA Adverse Event
Injury
·COOK INC·Product code LJS·November 13, 2012
HOMECHOICE CYCLER-REFURBISHED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·September 21, 2010
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·April 20, 2016
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018