17 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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X & V FACTOR DISCS
FDA 510(k)
FDA Class 1
·Microbiology
RMO
FDA UDI
Rmo, Inc.·00885797099747·LING RETNR BD 3X3 6 CS WO/INST
LEONE SPA
FDA UDI
LEONE SPA·08033707062431·TUBE MIM 22/51 R
Innomed, Inc.
FDA UDI
INNOMED, INC.·00840277114389·Nordt Micro Fracture 40 Degree Awl
ACUMED
FDA UDI
Acumed LLC·10806378096303·2.7mm QR Drill, Lag
Reprocessed 2.7mm Surgibit Drill, Lag
FDA UDI
SURETEK MEDICAL·B3908025021·
FacetLINK MI
FDA UDI
LINKSPINE, INC.·00817329024477·Dilator 2
Acumed
FDA UDI
Provision·B504OM8025020·
GOLIFE NASAL MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
CERAM-PRIME
FDA 510(k)
FDA Class 2
·Dental
TRUE TRACK
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·February 21, 2014
VISUM LED II SURGICAL LIGHT
FDA Adverse Event
Malfunction
·STRYKER COMMUNICATIONS·Product code FSY·October 19, 2012
CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·August 17, 2010
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025