21 results · 23ms · Sources: EU EUDAMED, US FDA

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Zimmer Nexel Total Elbow Ulnar Cement Diverter

FDA 510(k)
FDA Class 2 ·Orthopedic

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04051526768451·GENUMEDI PSS GREEN I

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04064984699533·GENUMEDI PSS BLUE, SIZE I

ORTHOPEDIC SALVAGE SYSTEM (OSS)

FDA UDI
Biomet Orthopedics, LLC·00880304240131·

MONOPOLY/CONKLUSION

FDA UDI
SIGNUS Medizintechnik GmbH·04047844039946·The CONKLUSION Pedicle Screw System is a spinal...

LEONE SPA

FDA UDI
LEONE SPA·08033707069218·TWISTER FOR PREF LIG TIES

TIBIAL INSERT IMPACTOR TIP

FDA Adverse Event
Malfunction ·CONFORMIS, INC.·Product code OOG·April 28, 2017

Ophthalmic Speculum

FDA UDI
KATENA PRODUCTS, INC.·00841668100158·KRATZ-BARRAQUER SPECULUM LARGE

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197456289·OESCH Phlebectomy hook Fig. 1...

MULTIFUNCTIONAL LINEAR PEN

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

MODIFICATION TO: XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM

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

SPECTRANETICS QUICK-CROSS SUPPORT CATHETER

FDA Adverse Event
Injury ·THE SPECTRANETICS CORPORATION·Product code DQY·March 6, 2019

HOMECHOICE PRO

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·June 6, 2013

ACCOLADE PLUS TMZF HIP STEM #5

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS CORK·Product code MEH·June 23, 2011

ANGIO-SEAL DEVICE

FDA Adverse Event
Injury ·ST. JUDE MEDICAL·Product code MGB·September 4, 2008

MICRA

FDA Adverse Event
Injury ·MEDTRONIC IRELAND·Product code PNJ·June 27, 2022

MISAGO RX Self Expanding Peripheral Stem

FDA Enforcement
Class II ·Terminated·Terumo Medical Corp·December 7, 2016

Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038200; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.

FDA Enforcement
Class I ·Ongoing·Medline Industries, LP·May 20, 2026

KING LAD SILI CONE SINGLE USE, King Systems devices/case, ETO Sterile. Size 2 / Infant Silicone King LAD¿ Patient Size: 10-20kg Product Usage: Laryngeal airway

FDA Enforcement
Class II ·Terminated·King Systems Corp.·November 28, 2012

Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722223, (2) 722224, (3) 722225, (4) 722226

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024