33 results · 25ms · Sources: EU EUDAMED, US FDA

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SCANDINAVIAN IVF SCIENCES AB, SPERMRINSE -20/100

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

PowerPICC SOLO

FDA UDI
Bard Access Systems, Inc.·00801741122712·Catheter Placement Kit

LEGION

FDA UDI
Smith & Nephew, Inc.·00885556701430·LEGION PRESSFIT STEM 17MM X 160MM

LIFEPAK® 500 Automated External Defibrillator

FDA UDI
PHYSIO-CONTROL, INC.·00721902559914·LP500AACBAZZZZZLP500EECGIAAAAAAZZZZZ

Millennia Software

FDA UDI
BRAEMAR MANUFACTURING, LLC·B146C4MA080·

Millennia Software

FDA UDI
BRAEMAR MANUFACTURING, LLC·B146C4MA000·

Millennia Software

FDA UDI
BRAEMAR MANUFACTURING, LLC·B146C4MA020·

EliA IgM Calibrator Strip

FDA UDI
Phadia AB·07333066012971·EliA IgM Calibrator Strip

AESCULAP BONE WAX

FDA 510(k)
FDA Unclassified ·Unknown

IMMAGE IMMUNOCHEMISTRY SYSTEM LIPOPROTEIN(A) LPAX REAGENT, ARRAY SYSTEM LIPOPROTEIN(A) LPA REAGENT, LIPOPROTEIN(A) CALIB

FDA 510(k)
FDA Class 2 ·Immunology

AUTOSOFT XC

FDA Adverse Event
Malfunction ·UNOMEDICAL A/S·Product code FPA·December 19, 2024

AUTOSOFT XC

FDA Adverse Event
Malfunction ·UNOMEDICAL A/S·Product code FPA·December 19, 2024

TUFF IMPLANT

FDA Adverse Event
Injury ·NORIS MEDICAL LTD·Product code DZE·May 27, 2026

TUFF IMPLANT

FDA Adverse Event
Injury ·NORIS MEDICAL LTD·Product code DZE·January 25, 2026

BONE WAX 24X2.5G

FDA Adverse Event
Malfunction ·B.BRAUN SURGICAL SA·Product code MTJ·October 30, 2019

ASR ACETABULAR IMPLANT 52

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KWA·March 12, 2013

PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code MGB·February 24, 2011

SMART CONTROL NITINOL STENT SYSTEM

FDA Adverse Event
Malfunction ·CORDIS DE MEXICO·Product code FGE·February 15, 2008

BONE WAX 24X2.5G

FDA Adverse Event
Malfunction ·B.BRAUN SURGICAL SA·Product code MTJ·May 7, 2019

BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

FDA Enforcement
Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015