31 results
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28ms
·
Sources: EU EUDAMED, US FDA
MODIFIED METAL SPECULUM & SPECIAL BULLET FORCEPS
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
HOTWIRE™ RF GUIDEWIRE
FDA UDI
Atraverse Medical, Inc·00850057445442·The HOTWIRE™ is a sterile, single-use guidewire...
Trochanteric Nail Tray, 11mm x 125˚
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665027976·
Symmetry Surgical
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482129500·Endo Supercut Scissors, Curved, 5MM
Elite®
FDA UDI
Ortho Organizers, Inc.·00190707051280·.018/045 U6R TBT/NC 0T 5 OFF
RETROGRADE CARDIOPLEGIA CANNULA, SELF-INFLATING, WITH MALLEABLE OR GUIDEWIRE STYLET
FDA 510(k)
FDA Class 2
·Cardiovascular
MODEL 1014 PC ELECTROMETER
FDA 510(k)
FDA Class 2
·Radiology
MENTOR SMOOTH ROUND HIGH PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·July 30, 2018
DIACAM (510(K) K 901019)
FDA Adverse Event
Other
·SIEMENS MEDICAL SYSTEMS·Product code KPS·March 13, 2001
STEALTHSTATION¿ S8 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·December 3, 2025
ASR ACETABULAR CUPS 52
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·November 10, 2010
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·January 8, 2013
TERUMO ADVANCED PERFUSION SYSTEM 1
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·February 24, 2014
RP RIVERPOINT MEDICAL 18G Brachy Grid B&K(TM) style, REF RPG-18 Product Usage: The Riverpoint Brachytherapy Grid is used during Brachytherapy procedures to assist with the precise insertion of the needle or other probes. The Riverpoint Brachytherapy Grid is placed against the skin of the patient to help the user place the needles in a grid pattern. The letters and numbers can also correspond with computerized grids to aid in placement.
FDA Recall
Terminated
·Riverpoint Medical, LLC·Product code IWJ·January 9, 2018
LIFECATH S PICC Catheter, Percutaneous, Intravascular Product Code 2296.211 Product Usage:: Intravascular catheter
FDA Recall
Terminated
·Vygon Corporation·Product code LJS·April 26, 2011
LIFECATH S PICC with Microflash Introducer Catheter, Percutaneous, Intravascular Product Code 2296.214 Product Usage: Intravascular catheter
FDA Recall
Terminated
·Vygon Corporation·Product code LJS·April 26, 2011
Churchill Medical Systems Central Line and Port Dressing Kit; Item AMS-8295CP-1 Intended use: Intravascular Administration Set
FDA Recall
Terminated
·Churchill Medical Systems, Inc.·Product code FPA·November 16, 2010
WalkMed Infusion Triton 90" 20 drop IV Administration Set with Needlefree Y-site Item # T090-000V Intended use: Intravascular Administration Set
FDA Recall
Terminated
·Churchill Medical Systems, Inc.·Product code FPA·November 16, 2010
WalkMed Infusion Triton 90" 20 drop IV Administration Set with Needlefree Y-site and 0.22 Intended use: Intravascular Administration Set
FDA Recall
Terminated
·Churchill Medical Systems, Inc.·Product code FPA·November 16, 2010
Churchill Medical Systems Central Line Dressing Kit; Item # AMS-8316CP-1 Intended use: Intravascular Administration Set
FDA Recall
Terminated
·Churchill Medical Systems, Inc.·Product code FPA·November 16, 2010