17 results
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35ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HYGIA HEALTH SERVICES REPROCESSED NELLCOT D-25 OXISENSOR II
FDA 510(k)
FDA Class 2
·Cardiovascular
Lumbar Interbody Fusion System (OLLIF)
FDA UDI
ADVANCED RESEARCH MEDICAL LLC·00850014575120·Lumbar Interbody Fusion System (OLLIF) Oblique ...
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0120150·Assembly, Screwdriver, Polyaxial, Lockable
STEVE MADDEN
FDA UDI
FGX INTERNATIONAL INC.·00193033440476·
True Position® Spacer System
FDA UDI
Spine Wave, Inc.·10840642107555·Implant, Lordotic, 27 (L) x 15 (H) mm, 7°
True Position®
FDA UDI
ATLAS SPINE, INC.·M68112080127150·27mm x 15mm Lordotic Spacer
ECAT PET SCANNER
FDA 510(k)
FDA Class 2
·Radiology
AL-40
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PNEUPAC PARAPAC VENTILATOR
FDA Adverse Event
Malfunction
·Product code BTL·December 30, 2019
STEM: AMISTEM C CEMENTED STD SIZE 0
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·November 7, 2021
TOTALCARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·February 22, 2013
ASR UNI FEMORAL IMPL SIZE 43
FDA Adverse Event
Injury
·DEPUY INTL LTD·Product code KWA·February 24, 2011
PROGRAMMING WAND
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·March 11, 2008
ON-Q C-BLOC 400ML, 2-14ML/HR SELECT-A-FLOW
FDA Adverse Event
Injury
·HALYARD - IRVINE·Product code MEB·April 17, 2015
Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·June 29, 2022
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024