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

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITS

FDA 510(k)
FDA Class 2 ·Hematology

SchureMed

FDA UDI
SCHUERCH CORPORATION·00810014608235·ALLEN, STERIS-AMSCO 3" STANDARD

MEDICON YASARGIL CLIP APPLYING FORCEPS

FDA 510(k)
FDA Class 2 ·Neurology

SUBDERMAL NEEDLE ELECTRODE FOR ELECTROENCEPHALOGRAPHY, MODELS PRO-E12SAF AND DEN-12SAF

FDA 510(k)
FDA Class 2 ·Neurology

WAVEWRITER ALPHA

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 24, 2023

ADULT BREATHING CIRCUIT

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD.·Product code BZE·November 27, 2008

Power Cords, marketed under the following models: a) CORD,METAL EARTH PIN, 2.5A,250V,2.5M,C7, 714682; b) PLFM CLASS II POWER CORD - AUSTRALIA, 716010; c) PLFM CLASS II POWER CORD - EUROPE, 716012; d) POWER CORD,AUSTRALIA,2.5A,250V,2.5M,C7, 008-0910-00; e) POWER CORD,EUROPEAN,2.5A,250V,2.5M,C7, 008-0912-00; f) LINE CORD (EURO), 4500-402; g) LINE CORD (UK), 4500-404; h) LINE CORD (AUS), 4500-406

FDA Enforcement
Class II ·Ongoing·Baxter Healthcare Corporation·April 17, 2024

ACCU-CHEK ® COMPACT TEST DRUM

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·April 26, 2013

ADAPTER SLEEVES 12/14 +5

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·July 22, 2008

UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code JJE·May 7, 2011

THE ELECTRODE STORE

FDA Adverse Event
Malfunction ·THE ELECTRODE STORE·Product code GXZ·July 17, 2021

Power Cords, marketed under the following models: a) CORD,METAL EARTH PIN, 2.5A,250V,2.5M,C7, 714682; b) PLFM CLASS II POWER CORD - AUSTRALIA, 716010; c) PLFM CLASS II POWER CORD - EUROPE, 716012; d) POWER CORD,AUSTRALIA,2.5A,250V,2.5M,C7, 008-0910-00; e) POWER CORD,EUROPEAN,2.5A,250V,2.5M,C7, 008-0912-00; f) LINE CORD (EURO), 4500-402; g) LINE CORD (UK), 4500-404; h) LINE CORD (AUS), 4500-406

FDA Recall
Open, Classified ·Baxter Healthcare Corporation·Product code DXN·March 26, 2024