12 results
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25ms
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Sources: EU EUDAMED, US FDA
TOTAL IRON IN SERUM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SpheRx
FDA UDI
Nuvasive, Inc.·00887517123718·SpheRx EXT Rod, 160mm
Ingenia
FDA UDI
Philips Medical Systems Nederland B.V.·00884838115712·Enables trained physicians to obtain cross-sect...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197074124·Cone Retractor
3x4 te...
ELECTROSURGICAL GROUNDING PAD
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head with Integrated Coupler ; AIM 4K Coupler, 20mm, C-Mount ; L11 LED Light Source with AIM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
1688 AIM 4K CAMERA HEAD WITH INTEGRATED COUPLER - INTERNATIONAL KIT
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY-SAN JOSE·Product code GCJ·September 13, 2024
OMNIPOD INSULIN PUMP
FDA Adverse Event
Injury
·INSULET CORPORATION·Product code LZG·October 4, 2012
CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·April 30, 2014
HEARTWARE® VENTRICULAR ASSIST SYSTEM
FDA Adverse Event
Injury
·HEARTWARE, INC·Product code DSQ·May 19, 2015
Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF): 781356. 2. Model Number (REF): 782109. 3. Model Number (REF): 782138. 4. Model Number (REF): 782160.
FDA Recall
Open, Classified
·Philips North America·Product code LNH·April 14, 2026
Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF): 781356. 2. Model Number (REF): 782109. 3. Model Number (REF): 782138. 4. Model Number (REF): 782160.
FDA Enforcement
Class II
·Ongoing·Philips North America·May 6, 2026