13 results · 23ms · Sources: EU EUDAMED, US FDA

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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