17 results · 19ms · Sources: EU EUDAMED, 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