14 results · 26ms · Sources: EU EUDAMED, US FDA

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PEM 2400 PET SCANNER

FDA 510(k)
FDA Class 2 ·Radiology

BUSCH®, BNA®

FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120320631·Diamond, pear, COOL DIAMANT, medium grit

BIOTRACE, MODEL 1730

FDA 510(k)
FDA Class 2 ·Neurology

SAFEPRO SAFETY SYRINGE

FDA 510(k)
FDA Class 2 ·General Hospital

EON MINI

FDA Adverse Event
Injury ·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 26, 2013

OT ULTRA2 METER

FDA Adverse Event
Injury ·LIFESCAN INC.·Product code NBW·March 28, 2011

ONE TOUCH ULTRA METER

FDA Adverse Event
Injury ·LIFESCAN, INC.·Product code NBW·April 18, 2008

Spirit Plus Bed, A-C Powered Hospital Bed

FDA Enforcement
Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

Spirit Select Bed, A-C Powered Hospital Bed

FDA Enforcement
Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025

The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018

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