13 results · 21ms · Sources: EU EUDAMED, US FDA

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APEX NRG

FDA 510(k)
FDA Unclassified ·Unknown

Baltic Denture System BD Load

FDA UDI
Merz Dental GmbH·D7091032743·Baltic Denture System BDLoad ↓ Lw6 PLSEum4DFl B...

REPROCESSED DISPOSABLE TROCARS

FDA 510(k)
FDA Class 1 ·Ear, Nose, Throat

TRILLIUM TRI-OPTIC MEASUREMENT CELL, MODEL TMC 25T, TMC38 T, TMC 50T

FDA 510(k)
FDA Class 2 ·Cardiovascular

XORAN

FDA Adverse Event
Malfunction ·XORAN TECHNOLOGIES, INC.·Product code JAK·May 9, 2011

FLEXI-SEAL FMS

FDA Adverse Event
Other ·CONVATEC·Product code KNT·June 7, 2006

GENESIS

FDA Adverse Event
Other ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 13, 2013

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·March 29, 2011

MESH - COMPOSIX KUGEL

FDA Adverse Event
Death ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·April 21, 2008

FLEXI-SEAL FECAL MANAGEMENT SYSTEM

FDA Adverse Event
Malfunction ·CONVATEC INC.·Product code KNT·October 20, 2016

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

Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024