18 results · 22ms · Sources: EU EUDAMED, US FDA

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Unity Total Knee System

FDA 510(k)
FDA Class 2 ·Orthopedic

SILICONE MCP

FDA UDI
Stryker GmbH·00886385021812·Instrument Tray Lid

STRAUMANN HEALING ABUTMENTS, HEALING CAPS, CLOSURE SCREWS

FDA 510(k)
FDA Class 2 ·Dental

EXPORT XT CATHETER, EXPORT AP CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

SOFT-VU ANGIOGRAPHIC CATHETER

FDA Adverse Event
Malfunction ·ANGIODYNAMICS·Product code DQO·May 23, 2013

HEART START XL

FDA Adverse Event
Malfunction ·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·June 22, 2011

FENESTRATED BIPOLAR FORCEPS INSTRUMENT

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL, INC·Product code GEI·September 12, 2008

OSTEO-SITE BONE BIOPSY NEEDLE

FDA Adverse Event
Malfunction ·COOK INC·Product code KNW·July 18, 2019

OSTEO-SITE BONE BIOPSY NEEDLE

FDA Adverse Event
Malfunction ·COOK INC·Product code KNW·June 17, 2019

KIT BD MAX EXT ENTERIC BACTERIAL PANEL

FDA Adverse Event
Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code PCH·June 21, 2022

OSTEO-SITE BONE BIOPSY NEEDLE

FDA Adverse Event
Malfunction ·COOK INC·Product code KNW·January 23, 2019

OSTEO-SITE BONE BIOPSY NEEDLE

FDA Adverse Event
Malfunction ·COOK INC·Product code KNW·July 16, 2019

OSTEO-SITE BONE BIOPSY NEEDLE

FDA Adverse Event
Malfunction ·COOK INC·Product code KNW·October 8, 2019

OSTEO-SITE BONE BIOPSY NEEDLE

FDA Adverse Event
Malfunction ·COOK INC·Product code KNW·July 17, 2019

OSTEO-SITE BONE BIOPSY NEEDLE

FDA Adverse Event
Malfunction ·COOK INC·Product code KNW·July 11, 2019

STABLE BASE

FDA Adverse Event
Injury ·LEONHARD LANG GMBH·Product code DRX·December 18, 2018

SIGN IM NAIL

FDA Adverse Event
Injury ·SIGN FRACTURE CARE INTERNATIONAL·Product code HSB·August 16, 2023

CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024