12 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Wesper Lab
FDA 510(k)
FDA Class 2
·Anesthesiology
Karatrode
FDA UDI
COMPASS HEALTH BRANDS CORP.·10850689007619·2"x 2" Foam, Case of 10
Karatrode
FDA UDI
COMPASS HEALTH BRANDS CORP.·00850689007612·2"x 2" Foam
Karatrode
FDA UDI
COMPASS HEALTH BRANDS CORP.·00092237900840·2"x 2" Foam
L300 PLUS SYSTEM (RIGHT, LEFT), L300 PLUS SYSTEM UPGRADE KIT (RIGHT, LEFT)
FDA 510(k)
FDA Class 2
·Neurology
ENVIRON-NP DISPOSABLE SYNTHETIC VINYL EXAM GLOVES, POWDERED
FDA 510(k)
FDA Class 1
·General Hospital
840 VENTILATOR
FDA Adverse Event
Malfunction
·PURITAN-BENNETT CORP.·Product code CBK·October 15, 2008
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011
ASR ACETABULAR CUPS 52
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KWA·July 2, 2013
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
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