21 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MI-750 PROCEDURAL/MINOR SURGICAL LIGHT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776384197·TC CRILE WOOD NH 7" SMOOTH
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319705056·Allis Tissue Forceps 10" (25cm), 5x6 teeth
TALOS®-A
FDA UDI
SpineArt SA·07640375237644·TALOS®-A (HA) PEEK PLANAR, SYMMETRIC IBFD D26 ...
TALOS® HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B167321408120·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B167311408120·
MiniSPC Button
FDA UDI
APPLIED MEDICAL TECHNOLOGY, INC.·00842071149932·14F x 0.8cm MiniSPC Low Profile Suprapubic Cath...
MiniSPC Button
FDA UDI
APPLIED MEDICAL TECHNOLOGY, INC.·00842071147310·14F x 0.8cm MiniSPC Low Profile Suprapubic Cath...
DETECT SURGICAL PACING AND MAPPING TOOL
FDA 510(k)
FDA Class 2
·Cardiovascular
ULTICARE DISPOSABLE PEN NEEDLES
FDA 510(k)
FDA Class 2
·General Hospital
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·February 20, 2025
MAGEC® SPINAL BRACING AND DISTRACTION SYSTEM
FDA Adverse Event
Injury
·NUVASIVE SPECIALIZED ORTHOPEDICS, INC.·Product code PGN·November 17, 2016
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code IOR·October 3, 2014
BARD
FDA Adverse Event
BARD ACCESS SYSTEMS, INC.·Product code DQO·May 27, 2013
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·May 31, 2011
PKG, BIOPSY FORCEPS, PUNCH, P/N 0250080290. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014
Lifesaver Single Patient Use Manual Resuscitator Product Usage: The Hudson RCI Lifesaver Single Patient Use manual resuscitator with pressure monitoring port is a disposable medical device intended for use on patients requiring temporary augmentation of ventilation with or without supplemental oxygen delivery during episodes of acute ventilatory failure or insufficiency.
FDA Enforcement
Class I
·Terminated·Teleflex Medical·July 1, 2015
C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear Accelerator is intended to provide sterotactic radiosurgery and precision radio-therapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·September 24, 2014
C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy linear accelerator; Versions 7, 8 and 9. The UNIQUE is not sold in the US. Product Usage: The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. The UNIQUE is a single energy medical linear accelerator. UNIQUE is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·December 11, 2013
Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc. Oncology Systems·May 22, 2013