21 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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CIRRUS PHOTO
FDA 510(k)
FDA Class 2
·Ophthalmic
Moretz / Polycel®
FDA UDI
MEDTRONIC XOMED, INC.·00763000033354·PROSTHESIS 1112184 MORETZ CAM PRT 10MM
Mortez
FDA UDI
MEDTRONIC XOMED, INC.·00681490033541·PROSTHESIS 1112184 MORETZ CAM PRT 10MM
Evolve Stem Template - Size 1
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215055639·
Evolve Stem Template - Size 4
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215055660·
Evolve Stem Template - Size 3
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215055653·
Evolve Stem Template - Size 5
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215055677·
Evolve Stem Template - Size 2
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215055646·
BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MEDPOR CONTAIN CAN IMPLANT
FDA 510(k)
FDA Class 2
·Dental
CASPIAN Spinal System
FDA UDI
VB Spine LLC·10888857242494·Anti-Torque Guide
ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)
FDA Adverse Event
Malfunction
·ANGIOSCORE, INC·Product code LIT·November 18, 2015
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·June 3, 2011
LARGE NEEDLE DRIVER INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC.·Product code GCJ·July 27, 2007
DERMABOND TOPICAL SKIN ADHESIVE
FDA Adverse Event
Other
·CLOSURE MEDICAL CORPORATION·Product code MPN·August 6, 2008
BD¿ ALLERGY SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·November 19, 2021
EXPRESSEW III AC+ GUN
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SÃ RL·Product code LXH·September 10, 2019
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.
FDA Enforcement
Class II
·Terminated·Carl Zeiss Meditec AG·December 9, 2015
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021