16 results · 27ms · Sources: EU EUDAMED, US FDA

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POLLER CALIBRANTS

FDA 510(k)
FDA Class 2 ·Hematology

Monolith

FDA UDI
Nuvasive, Inc.·00887517677297·Monolith Core, Ø14x39mm

HEAD FIXATION ARC AND TABLE BASE

FDA 510(k)
FDA Class 2 ·Neurology

OverStitch 2-0 Polypropylene Suture

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

CDS/R/4K DILUENT/SHEATH, 20L

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS DIV/CELLDYN·Product code GKL·April 12, 2007

CD SAPPHIRE, CD 4000 SYSTEMS DILUENT/SHEATH

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS DIV/CELLDYN·Product code GKL·December 8, 2006

ZEPHIR ANTERIOR CERVICAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDIC INC.·Product code KWQ·June 11, 2009

CELL-DYN DILUENT/SHEATH

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKL·January 5, 2007

ELECTRODE, PACEMAKER, PERMANENT

FDA Adverse Event
Death ·RICE CREEK MFG·Product code DTB·March 6, 2013

RENAL - DISPOSABLE

FDA Adverse Event
Product code KDJ·February 15, 2011

SELECTSECURE

FDA Adverse Event
Injury ·MPRI·Product code NVN·August 8, 2014

Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CATHETER

FDA Enforcement
Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO

FDA Enforcement
Class II ·Terminated·Terumo BCT, Inc.·November 22, 2017

HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical Use Only, REF 51416, Rx Only, STERILE EO

FDA Enforcement
Class II ·Terminated·Terumo BCT, Inc.·November 22, 2017

HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical Use Only, REF 51416, Rx Only, STERILE EO

FDA Recall
Terminated ·Terumo BCT, Inc.·Product code JQC·October 20, 2017

HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO

FDA Recall
Terminated ·Terumo BCT, Inc.·Product code JQC·October 20, 2017