16 results · 28ms · Sources: EU EUDAMED, US FDA

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GAMMA-BSM, BETA-BSM

FDA 510(k)
FDA Class 2 ·Orthopedic

LEONE SPA

FDA UDI
LEONE SPA·08033707065647·INTRAORAL ELASTICS 2,5 oz 3/16" green

Millennium

FDA UDI
Avalign Technologies, Inc.·00190776363291·Lucas Curette, #1R-1L

N/A

FDA UDI
BIOMET MICROFIXATION, INC·00841036028107·

Nitinol Stone Extractor, straight basket, 4 wires, 2.5 Fr, 90cm

FDA UDI
Promepla·03700512967729·

ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT AND ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT WITH HYDROXYAPATITE

FDA 510(k)
FDA Class 2 ·Orthopedic

COOK ZILVER BILIARY STENT

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

VERSAFITCUP DM ACETABULAR CUP 50

FDA Adverse Event
Injury ·Product code MEH·September 12, 2014

VERSAFITCUP DM SHELL 50

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL, SA·Product code MEH·June 26, 2015

LANX SPINOUS PROCESS FUSION PLATE

FDA Adverse Event
Injury ·LANX, INC.·Product code KWP·March 17, 2011

RIATA ACTIVE FIXATION

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·May 2, 2013

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 15, 2014

PIN COLLET

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code GET·April 19, 2011

BIPAP AUTOSV ADV

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code MNS·March 10, 2022

BD Vacutainer CPT Cell Preparation Tube with Sodium Heparin, 8 mL, 16 x 125 mm, Catalog #REF 362753, Lot #4063409 with expiry 03/2015, intended for the collection of whole blood and the separation of mononuclear cells.

FDA Enforcement
Class II ·Terminated·Becton Dickinson & Company·September 3, 2014

Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

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