10 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Personal Lubricant Jelly
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Blade Scalpel
FDA UDI
KATENA PRODUCTS, INC.·00841668113509·MINIATURE BLADE #67 (BX/5)
HCMI X-RAY
FDA 510(k)
FDA Class 2
·Radiology
EyeArt
FDA 510(k)
FDA Class 2
·Ophthalmic
GENERATOR MODEL UNKNOWN
FDA Adverse Event
Injury
·HOUSTON·Product code LYJ·April 27, 2026
ACTIVA
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code MHY·October 27, 2014
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE -MOUNTAIN HOME·Product code FKX·August 11, 2011
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 2, 2013
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
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021