22 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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