35 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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S51D DIGITAL ENDOSCOPY CAMERA
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Ti-MESH
FDA UDI
pfm medical titanium gmbh·04042301117809·Ti-MESH 12" X 12" Strong 65g/m²
CUSTOM PROCEDURE KIT
FDA UDI
MEDIVATORS INC.·40677964004443·CUSTOM PROCEDURE KIT
TEWA
FDA UDI
asia-med Gesellschaft für Akupunkturbedarf mbH & Co. KG·04251282501969·TeWa CB-Type 3030 (s): uncoated acupuncture ne...
TEWA
FDA UDI
asia-med GmbH·04251282509286·TeWa CB-Type 3030 (s): uncoated acupuncture ne...
PowerPICC
FDA UDI
Bard Access Systems, Inc.·00801741101441·Catheter Placement Kit
Brite-Gear
FDA UDI
ORMCO CORPORATION·00889989023534·Facebow SHORT #4 044 YELLOW
GeneXpert Dx System
FDA UDI
CEPHEID·07332940004170·Additional catalog number: 900-0424R
FLUROPERM 60-OK, PARAGON HDS-OK
FDA 510(k)
FDA Class 2
·Ophthalmic
SENSATION -VACUUM ASSIST DEVICES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
COYOTE¿ ES
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LIT·March 12, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 24, 2011
ANEURX STENT GRAFT (FLEXIBLE) WITH XPEDIENT
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR·Product code MIH·February 21, 2008
EVIS X1 VIDEO SYSTEM CENTER
FDA Adverse Event
Injury
·SHIRAKAWA OLYMPUS CO., LTD.·Product code FET·September 27, 2024
INSORB 30 STAPLER
FDA Adverse Event
Injury
·COOPERSURGICAL, INC.·Product code GDW·November 1, 2023
UNKN BIRMINGHAM HIP RESURFACING (BHR) IMPL
FDA Adverse Event
Injury
·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code NXT·July 9, 2024
CMD 20-1413 GLENOID IMPLANT
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code KWS·March 11, 2022
BrightView SPECT model number 882480 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, and total body studies, as well as circular-orbit and noncircular orbit SPECT studies, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors only).
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·April 12, 2017
BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015
BrightView XCT
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·February 22, 2017