20 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DIA-ROOT BIO MTA
FDA 510(k)
FDA Class 2
·Dental
StarDental Instrument Solutions
FDA UDI
DENTALEZ, INC.·D7022001740·CLASSIQUE DIA INSTRUMENTS 110P
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114049·J-SHAPED CANNULA 25GA STRAIGHT (PK/10)
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306823329·Marina Nasal Osteotome, 3mm, 18cm
Initia Total Hip System
FDA UDI
KYOCERA MEDICAL CORPORATION·04580810058430·"MX LINER 36-72/74
Size:36-72/74
Type:Elevated
...
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306830945·Telescope, 4mm OD, 30 Degree, 17.5cm Length
DESS dental smart solutions
FDA UDI
TERRATS MEDICAL SL.·08435457200376·External Hex Universal
Initia Total Hip System
FDA UDI
KYOCERA CORPORATION·04547898306884·MX LINER 36-72/74
Liberty SI
FDA UDI
Spinal Simplicity, LLC·M9432001740000·Parallel Pin Placement Guide
O-arm O2 Imaging System
FDA 510(k)
FDA Class 2
·Radiology
ACTION AF-1 WHEELCHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·December 18, 2015
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·January 11, 2016
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 24, 2014
CAPSURE SENSE
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 10, 2011
UNK
FDA Adverse Event
Injury
·ETHICON INC.·Product code FTL·July 1, 2013
ANSPACH***REF SP-5000-00***Threaders, Arthroscopic Suture Anchor***Rx Only*** This device is intended to be used with Anspach Systems
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·July 2, 2014
StarDental Classique(TM) Diamond Dental Bur. Used for specific applications in dental procedures.
FDA Enforcement
Class II
·Terminated·Dental EZ Stardental Division·June 19, 2013
Azurion 5 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722227 (2) 722228
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024
Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.
FDA Enforcement
Class II
·Terminated·Bayer Corp·June 11, 2014