22 results · 23ms · Sources: EU EUDAMED, US FDA

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DEPUY PULSE ANTERIOR CERICAL PLATE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

VITROS

FDA UDI
ORTHO-CLINICAL DIAGNOSTICS, INC.·10758750004393·VITROS Chemistry Products AMYL Slides

HEX-FIX

FDA UDI
Smith & Nephew, Inc.·03596010042361·HEX-FIX TIGHTENING BAR WITH HANDLE

Rod long

FDA UDI
Noras MRI products GmbH·04251269203428·

POWDER-FREE VINYL PATIENT EXAMINATION GLOVES

FDA 510(k)
FDA Class 1 ·General Hospital

SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273

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

BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code FPA·April 26, 2024

BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·September 17, 2025

BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code FPA·April 15, 2024

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE SUZHOU·Product code CAW·May 14, 2013

FUSION OMNI-TOME

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code KNS·May 27, 2011

VERSACARE

FDA Adverse Event
Malfunction ·HILL-ROM RITTER·Product code FNL·August 15, 2008

NSK

FDA Adverse Event
Malfunction ·NAKANISHI INC.·Product code EFB·December 6, 2018

NSK

FDA Adverse Event
Malfunction ·NAKANISHI INC.·Product code EFB·December 6, 2018

BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code FPA·April 20, 2026

NSK

FDA Adverse Event
Injury ·NAKANISHI INC.·Product code EFB·February 11, 2020

VITROS Chemistry Products AMYL Slides packaged as 300 slides/pack catalog number 1202670 and packaged as 90 slides/pack catalog number 8112724 VITROS AMYL Slides quantitatively measure amylase (AMYL) activity in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

FDA Enforcement
Class II ·Terminated·Ortho-Clinical Diagnostics·November 27, 2013

VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/90 SLDS, Product Code 8112724, UDI # 10758750004393 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems.

FDA Enforcement
Class II ·Terminated·Ortho-Clinical Diagnostics·June 24, 2020

VITROS Chemistry Products AMYL Slides packaged as 300 slides/pack catalog number 1202670 and packaged as 90 slides/pack catalog number 8112724 VITROS AMYL Slides quantitatively measure amylase (AMYL) activity in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

FDA Recall
Terminated ·Ortho-Clinical Diagnostics·Product code CIW·June 12, 2013

VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/90 SLDS, Product Code 8112724, UDI # 10758750004393 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems.

FDA Recall
Terminated ·Ortho-Clinical Diagnostics·Product code CIW·May 11, 2020