13 results
·
23ms
·
Sources: EU EUDAMED, US FDA
ASTRA PRINTER PAPER #88112-CHLORIDE SILV
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PROTECTIVE BAG SIZE 3 100 PCS
FDA UDI
PaloDEx Group Oy·06430035873661·
ACUMED
FDA UDI
Acumed LLC·10806378095023·2.3 mm MultiScrew/Lag Screw Caddy
VENTRIX TRUE TECH VENTRICULAR TUNNELING PRESSURE MONITORING KIT, MODEL NL960-V
FDA 510(k)
FDA Class 2
·Neurology
EVOTECH ENDOSCOPE CLEANER AND REPROCESSOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MENTOR SILTEX CONTOUR PROFILE MODERATE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·December 30, 2020
BUR 1884562HS 3PK AGGRESSIVE ROUTER 4.5M
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code EQJ·May 9, 2014
IMPLANT PDS3000M 6PK PILLAR PALATAL
FDA Adverse Event
Injury
·XOMED MFG JACKSONVILLE·Product code LRK·October 19, 2012
BESTCARE
FDA Adverse Event
BESTCARE LLC·Product code FSA·February 25, 2015
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
FDA Enforcement
Class I
·Terminated·Animas Corporation·April 10, 2013
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