11 results
·
27ms
·
Sources: EU EUDAMED, US FDA
HELFET ELBOW PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
ACUMED
FDA UDI
Acumed LLC·10806378097782·FFN 3.1mm Reamer
CENEFOM PVA SURGICAL SPEAR
FDA 510(k)
FDA Class 2
·Ophthalmic
LIQUICHEK LIPIDS CONTROL, MODEL 641, 642
FDA 510(k)
FDA Class 1
·Clinical Chemistry
HEARTSTART ONSITE
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·February 21, 2014
PATIENT INTERFACE 8253410 NIM NEURO 3.0
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED, INC.·Product code ETN·October 18, 2012
ANTI-REFLEC Y-SET 8"
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code ---·August 17, 2010
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025