37 results · 11ms · 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.

Intera Achieva 1.5T Pulsar. Model (REF) Number 781171.

FDA Recall
Open, Classified ·Philips North America·Product code LNI·January 3, 2024

Intera 1.5T Achieva Nova-Dual. Model (REF) Number 781173.

FDA Recall
Open, Classified ·Philips North America·Product code LNI·January 3, 2024

Ingenia 3.0T CX. Model (REF) Numbers 781271, 782105.

FDA Recall
Open, Classified ·Philips North America·Product code LNI·January 3, 2024

Achieva 1.5T Conversion. Model (REF) Numbers 781346, 781283.

FDA Recall
Open, Classified ·Philips North America·Product code LNI·January 3, 2024

Intera 1.5T Achieva Nova. Model (REF) Numbers 781172.

FDA Recall
Open, Classified ·Philips North America·Product code LNI·January 3, 2024

SmartPath to dStream for XR and 3.0T. Model (REF) Numbers 781270, 782113, 782129.

FDA Recall
Open, Classified ·Philips North America·Product code LNI·January 3, 2024

7.5 cm Large Rotating Craniotome Attachment. Use with XMax, microMax, and eMax Systems Ref: CRANI-L-R Intended for cutting and shaping bone including the spine and cranium

FDA Recall
Open, Classified ·The Anspach Effort, Inc.·Product code HBC·December 7, 2022

6.5 cm Adult Craniotome, Thin Foot Plate Attachment. Use with XMax, microMax, and eMax Systems Ref: CRANI-A-01 intended for cutting and shaping bone including the spine and cranium by trained medical/surgical personnel

FDA Recall
Open, Classified ·The Anspach Effort, Inc.·Product code HBC·December 7, 2022

6.5 cm Adult Rotating Craniotome Attachment. Use with XMax, microMax, and eMax Systems Ref: CRANI-A-R intended for cutting and shaping bone including the spine and cranium

FDA Recall
Open, Classified ·The Anspach Effort, Inc.·Product code HBC·December 7, 2022

Adult Craniotome Ref: CRANI-A-G1 Intended for cutting and shaping bone including the spine and cranium

FDA Recall
Open, Classified ·The Anspach Effort, Inc.·Product code HBC·December 7, 2022

ADVIA Centaur BNP (B-type Natriuretic Peptide), Catalog Numbers: 02816138 (100 tests), 02816634 (500 tests)

FDA Recall
Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code NBC·December 18, 2017

6.5 cm Adult Rotating Craniotome Attachment. Use with XMax, microMax, and eMax Systems. Ref: CRANI-A Intended for cutting and shaping bone including the spine and cranium

FDA Recall
Open, Classified ·The Anspach Effort, Inc.·Product code HBC·December 7, 2022

VITROS NT-proBNP Reagent, Cat No. 6802156 Product Usage: For in vitro diagnostic use only. For the quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the diagnosis of congestive heart failure and for the risk stratification of acute coronary syndrome and congestive heart failure. The test is further indicated as an aid in the assessment of increased risk of cardiovascular events and mortality in patients at risk for heart failure who have stable coronary artery disease. The test can also be used in the assessment of heart failure severity in patients diagnosed with congestive heart failure.

FDA Recall
Open, Classified ·ORTHO-CLINICAL DIAGNOSTICS Felindre Meadows Bridgend United Kingdom·Product code NBC·November 1, 2018

Pediatric Craniotome Ref:CRANI-P-G1

FDA Recall
Open, Classified ·The Anspach Effort, Inc.·Product code HBC·December 7, 2022

7.5 cm Large Craniotome Attachment Use with XMax, microMax, and eMax Systems. Ref: CRANI-L Intended for cutting and shaping bone including the spine and cranium

FDA Recall
Open, Classified ·The Anspach Effort, Inc.·Product code HBC·December 7, 2022

6.5 cm Pediatric Craniotome Attachment. Use with XMax, microMax, and eMax Systems Ref: CRANI-P Intended for cutting and shaping bone including the spine and cranium

FDA Recall
Open, Classified ·The Anspach Effort, Inc.·Product code HBC·December 7, 2022

Adult Craniotome, Large Ref: CRANI-L-G1 Intended for cutting and shaping bone including the spine and cranium

FDA Recall
Open, Classified ·The Anspach Effort, Inc.·Product code HBC·December 7, 2022