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

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RECON system - Compression Screws

FDA 510(k)
FDA Class 2 ·Orthopedic

Surgical Instrument

FDA UDI
Jeil Medical Corporation·08800089476848·

Surgical Instrument

FDA UDI
Jeil Medical Corporation·08800089476688·

HAcancellous™ PEEK-C

FDA UDI
INNO Holdings, Inc.·M711591517080·HAcancellous PEEK-C, 15L x 17W x 8H x 8°, HA PE...

Cadet Cervical Cage

FDA UDI
VALORUS SPINE LLC·00811771034091·Cadet Cervical Cage, 15mm x 17mm x 08mm, 7° Lor...

Cadet Cervical Cage

FDA UDI
VALORUS SPINE LLC·00811771033469·Cadet Cervical Cage, 15mm x 17mm x 08mm, Non-Lo...

BWCSH-1 SHARPS CONTAINER

FDA 510(k)
FDA Class 2 ·General Hospital

PATIENT SAFE LUER CAP

FDA 510(k)
FDA Class 2 ·General Hospital

PEN NDL 32G 4MM 90 CT MAIL ORDER ONLY

FDA Adverse Event
Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·May 16, 2019

THREADED HOLDING SLEEVE FOR POLYAXIAL SCREWS

FDA Adverse Event
Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code LXH·August 13, 2019

ALTRUA

FDA Adverse Event
Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·July 6, 2011

PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

FDA Adverse Event
Malfunction ·MEDTRONIC MILACA, INC.·Product code LWP·June 7, 2013

VERSACARE

FDA Adverse Event
Malfunction ·HILL-ROM RITTER·Product code FNL·September 10, 2008

Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·March 20, 2013

Precise Treatment Table. To be used as part of radiation therapy treatment process.

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·April 17, 2013

All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·March 12, 2014

Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,

FDA Enforcement
Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025