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