17 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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