33 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ULTIMED ULTICARE SAFETY SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014606484·MIDMARK CHIC CST 5.25 SOFTCARE PLUS
Conformis Hip System
FDA UDI
Conformis, Inc.·00810933030094·REAMER, ACETABULAR, 54MM FULL
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702290332·ELVAREX 3/THIGH HIGH/OPEN TOE, KNEE FUNCTION/WI...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702367393·Elvarex 3/Knee High/Slant-Closed Toe-Elephantia...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702247534·Elvarex 2/Thigh High/Slant-Open Toe/Dotted Sil....
Kalitec Universal Instruments
FDA UDI
Kalitec Direct LLC·B07301K0606000·Tray, Base, 6"
SYVA EMIT 2000 THYROXINE ASSAY, CALIBRATORS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SUPREMA POWERED WHEELCHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
QUILL SRS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code NEW·April 30, 2009
QUILL SRS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code NEW·April 30, 2009
QUILL SRS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code NEW·August 24, 2009
OT VERIO PRO PLUS METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 26, 2013
ENDURANT ABDOMINAL STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·April 22, 2011
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 22, 2008
QUILL SRS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code NEW·March 12, 2009
Mercury Spinal System DIA 5.5 x 110mm Straight Rod, Part Number: 60101-110. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
FDA Enforcement
Class III
·Terminated·Spinal Elements, Inc·May 15, 2013
GORE DUALMESH® PLUS BIOMATERIAL
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code FTL·October 25, 2019
QUILL SRS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code NEW·October 31, 2008
DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 28 cm Straight Basic Kit, Catalog Number/REF 10302804, 510 (k) 080400, Sterile --- Manufactured in USA by AngioDynamics, Inc. 603 Queensbury Avenue, Queensbury, NY 12804
FDA Recall
Terminated
·Angiodynamics, Inc.·Product code MSD·January 8, 2010