94 results · 24ms · Sources: EU EUDAMED, US FDA

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Brisbane ALIF Device, Gladstone ALIF Device

FDA 510(k)
FDA Class 2 ·Orthopedic

External Fixation

FDA UDI
Life Spine, Inc.·00190837023010·Washer

SANTORINI Corpectomy Cage System

FDA UDI
VB Spine LLC·10888857243149·Bone Packing Mold Size 12x17 mm

AKITA2 APIXNEB

FDA 510(k)
FDA Class 2 ·Anesthesiology

RESTORATION ACETABULAR WEDGE AUGMENTS

FDA 510(k)
FDA Class 2 ·Orthopedic

PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

FDA Adverse Event
Injury ·ETHICON INC.·Product code NEW·April 21, 2020

VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

FDA Adverse Event
Injury ·ETHICON INC.·Product code GAM·April 21, 2020

NI

FDA Adverse Event
Injury ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·June 4, 2021

M2A MAGNUM PF CUP 52MM O.D. X 46MM I.D.

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code KWA·July 22, 2011

9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 10, 2013

LIFEPAK CR PLUS DEFIBRILLATOR

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC.·Product code MKJ·September 18, 2008

FILIFORM DOUBLE PIGTAIL URETERAL STENT SET

FDA Adverse Event
Malfunction ·COOK INC·Product code FAD·June 30, 2022

FILIFORM DOUBLE PIGTAIL URETERAL STENT SET

FDA Adverse Event
Malfunction ·COOK INC·Product code FAD·June 30, 2022

BLACK SILICONE FILIFORM DOUBLE PIGTAIL URETERAL STENT

FDA Adverse Event
Malfunction ·COOK INC·Product code FAD·January 31, 2023

FILIFORM DOUBLE PIGTAIL URETERAL STENT SET

FDA Adverse Event
Malfunction ·COOK INC·Product code FAD·January 2, 2020

UNK LINX MAGNETIC IMPLANT

FDA Adverse Event
Injury ·TORAX MEDICAL, INC.·Product code LEI·September 13, 2019

Thio Med w/Dex, Hem, Vit K (9ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes

FDA Enforcement
Class II ·Terminated·Remel Inc·May 29, 2019

OSCOR ADELANTE BREEZEWAY 10F C55¿ S79CM D84CM Catalog # AB101076 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

FDA Enforcement
Class II ·Terminated·Oscor, Inc.·December 28, 2016

Sysmex XN-Series Fluorocell PLT, Catalog #CD994563. Distributed in the U.S.A. by Sysmex America, Inc., Lincolnshire, IL. Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the Sysmex XN-Series automated hematology analyzers.

FDA Enforcement
Class II ·Terminated·Sysmex America, Inc.·September 5, 2018

Thio Med w/o Ind, w/Dex (9ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes

FDA Enforcement
Class II ·Terminated·Remel Inc·May 29, 2019