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

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VACUTAINER BRAND CTAD TUBE (MULTIPLE)

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

BD VACUTAINER® CTAD BLOOD COLLECTION TUBES

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·June 4, 2018

BD VACUTAINER® CTAD BLOOD COLLECTION TUBES

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·May 31, 2018

BD VACUTAINER® CTAD BLOOD COLLECTION TUBES

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·May 3, 2018

XCALIBER BONE SCREWS

FDA UDI
ORTHOFIX SRL·18054242512646·BONE SCREW HAND DRILL STERILE

MEDPOR CONTAIN IMPLANT

FDA 510(k)
FDA Class 2 ·Dental

MIDDLE EAR PICKS, HOOKS CURETTES,

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

ACCESSORIES

FDA Adverse Event
Malfunction ·ABBOTT VASCULAR INC.·Product code DQX·March 20, 2025

ACTIVA

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·March 6, 2013

SPRINT QUATTRO SECURE

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·February 15, 2011

PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

FDA Adverse Event
Malfunction ·MEDTRONIC MILACA, INC.·Product code LWP·August 8, 2014

INDEFLATOR

FDA Adverse Event
Malfunction ·ABBOTT VASCULAR INC.·Product code MAV·February 27, 2024

INDEFLATOR

FDA Adverse Event
Malfunction ·ABBOTT VASCULAR INC.·Product code MAV·March 21, 2024

M2A-MAGNUM MOD HD SZ 46MM

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWA·August 20, 2018

Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

FDA Enforcement
Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012

Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

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