20 results · 34ms · Sources: EU EUDAMED, US FDA

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MONOLYTH C 600 AND 1200 HOLLOW FIBER MEMBRANE LUNG WITH INTEGRATED SOFTSHELL VENOUS RESERVOIR , CVR 600 AND 1200 SOFTSHE

FDA 510(k)
FDA Class 2 ·Cardiovascular

DeRoyal

FDA UDI
DEROYAL INDUSTRIES, INC.·00749756095204·ECONOMY ARM SLING

APEX Knee System

FDA UDI
Omni Life Science, Inc.·00841690199250·AK3 PS Notch Reamer Guide Size 3/2+

Sprint®

FDA UDI
Forestadent Bernhard Förster GmbH·EFOR79901031·Sprint II Bracket McLaugh/Benn/Trev. .018" max....

Sprint®

FDA UDI
Forestadent Bernhard Förster GmbH·EFOR79901030051·Sprint II Bracket McLaugh/Benn/Trev. .018" max....

Sprint®

FDA UDI
Forestadent Bernhard Förster GmbH·EFOR79901031001·Sprint II Bracket McLaugh/Benn/Trev. .018" max....

Sprint®

FDA UDI
Forestadent Bernhard Förster GmbH·EFOR79901030101·Sprint II Bracket McLaugh/Benn/Trev. .018" max....

EARGO

FDA UDI
Eargo, Inc.·00850010429151·EARGO NEO HiFi, Replacement Hearing Device, Left

Shoreline ACS

FDA UDI
Seaspine Orthopedics Corporation·10889981161972·Tray, Plates, Screws, and Locking Covers

General

FDA UDI
Seaspine Orthopedics Corporation·10889981289263·BOTTOM TRAY

V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 1 Plus Low Temperature Sterilization System, V-PRO 1 Low Temperature Sterilization System

FDA 510(k)
FDA Class 2 ·General Hospital

100KGY E-POLY ACETABULAR LINERS- ADDITIONAL PROFILES: +3 MAXROM AND +3 HI-WALL

FDA 510(k)
FDA Class 2 ·Orthopedic

UNKNOWN LINER

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JDI·February 10, 2015

RX CYTOLOGY BRUSH

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code FDX·March 5, 2013

CAPSUREFIX NOVUS

FDA Adverse Event
Injury ·MPRI·Product code DTB·August 7, 2014

ASKU

FDA Adverse Event
Malfunction ·MEDTRONIC, INC.·Product code DTB·February 15, 2011

BD¿ SYRINGE WITH BD LUER-LOK¿ TIP

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·January 8, 2018

UNKNOWN

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·June 9, 2021

ZIMMON PANCREATIC STENT

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·October 16, 2020

Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number 320-46-10, b) +2.5mm, Item Number 320-46-13; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024