11 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MOBIS SPINAL IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00610821·
STACKHOUSE SMOKE EVACUATOR, MODELS ST-3000, ST 3100
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TPO IGG ANTIBODY EIA TEST
FDA 510(k)
FDA Class 2
·Immunology
INCLUSIVE TAPERED IMPLANT 4.7 MMD X 11.5 MML X 4.5 MMP
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·May 2, 2024
NA
FDA UDI
Zimmer, Inc.·00889024186330·
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code CBK·April 9, 2013
INRATIO2
FDA Adverse Event
Other
·ALERE SAN DIEGO, INC.·Product code GJS·April 8, 2011
LIFEVEST WCD 3000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·June 13, 2008
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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015