1,166 results
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10ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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Natus neoBLUE blanket LED Phototherapy system which includes the following items: 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007302 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS
FDA Enforcement
Class II
·Terminated·Natus Medical Incorporated·April 22, 2015
Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS
FDA Enforcement
Class II
·Terminated·Natus Medical Incorporated·December 21, 2016
Integra¿ LED Battery Charger, Single Bay. Product Number: 90523 The LED Headlight System Battery Charger (90523) is an accessory to the LED Headlight System: 90520US - LED Headlight w/Battery & AC/DC Power Supply - US 90520EU - LED Headlight w/Battery & AC/DC Power Supply - EU 90520UK - LED Headlight w/Battery & AC/DC Power Supply - UK 90520AU - LED Headlight w/Battery & AC/DC Power Supply - AU Product Usage: The Integra LED Headlight System Is designed to provide illumination to aid visualization during minor surgical, diagnostic, or therapeutic procedures
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·July 9, 2014
Updated Natus neoBLUE blanket LED Phototherapy Systems. It provides phototherapy underneath the infant and can be used in a bassinet, open bed, radiant warmer, incubator, or while holding the infant. Affected systems including: 1) Updated light boxes (serial number xxxx004283 or greater) have protection built in to turn off the device if an overheat condition is detected. 2) Updated fiberoptic blankets (Lot Nxxxx16-xx or greater) have an improved fiberoptic cable end to reduce the degradation and increase its useful life. Affected Part Numbers and Description: 006244 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007302 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS
FDA Enforcement
Class II
·Terminated·Natus Medical Incorporated·December 21, 2016
reVive Light Therapy Pain Relief Device (Model Number: RVPNSYS) Product Usage: The reVive Light Therapy Pain Relief Device is a device designed to deliver LED light spectrum in 880nm and 660nm directly into the body tissue to increase circulation and temporarily relieve pain associated with muscle spasms, arthritis, general aches and strains.
FDA Enforcement
Class II
·Terminated·LED Technologies, LLC·May 4, 2016
The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infrared (IR) light-emitting diodes (LEDs) as well as an electronics control unit for the LEDs which includes its own battery power supply. The measured LED positions can be used in one of three different modes of operation: Patient tracking, Registration using surface matching, and Automatic intra-operative mask registration.
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·December 31, 2025
Freedom Cordless LED Light System. Freedom System, Standard Length, Part Number 910863-1, Serial Numbers 77001000-77003470 and Freedom System, Long Length, Part Number 910863-2, Serial Numbers 77001000-77003470. Freedom Cordless LED Light System is a Class I Medical Device. The device listing number this product is E115952. The intended use of this device is to illuminate oral structures and operating areas.
FDA Enforcement
Class II
·Terminated·Kerr Corporation·November 28, 2012
EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs).
FDA Enforcement
Class II
·Terminated·Haag-Streit USA Inc·March 29, 2017
Replacement LED PCB Kit, part number 001840, of the Natus neoBLUE (aka neoBLUE 2) Phototherapy system. Neonatal phototherapy.
FDA Enforcement
Class II
·Terminated·Natus Medical Incorporated·December 31, 2014
Flex IUI Set with LED Lighted Speculum and Test kit, SKU fls1001
FDA Enforcement
Class II
·Ongoing·Tenderneeds Fertility LLC·August 11, 2021
#1 MAC F/O LARYNGOSCOPE; F/O Laryngoscope Set-MAC; F/O Laryngoscope Set-MAC W/LED
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corporation·July 6, 2022
UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF:B23858
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Inc.·September 24, 2025
cobas Liat Analyzer, for in vitro diagnostic use.
FDA Enforcement
Class II
·Terminated·Roche Molecular Systems, Inc.·September 9, 2015
UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C34520
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Inc.·September 24, 2025
UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C11478
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Inc.·September 24, 2025
Olympus Scientific Solutions Americas Corporation ( OSSA ) VANTA¿ XRF Analyzer. Model Vanta VCR and Vanta VMR Analytical X-ray systems
FDA Enforcement
Class II
·Terminated·Olympus Scientific Solutions Americas·February 8, 2017
UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer REFs:B24802, 629029, B63322
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Inc.·September 24, 2025
Quasar Power Pack contains a Baby Quasar and a Baby Blue. The Baby Quasar is an infrared LED lamp. The Baby Blue uses blue LED light to be used in combination with the Baby Quasar to treat acne. The Quasar Power Pack is labeled in part: "***BABY QUASAR & BABY BLUE***QUASAR POWERPACK***FOR YOUTHFUL, RADIANT, CLEAR SKIN***SKIN REJUVENATING SYSTEM WITH SEQUEPULSE PLUS ADVANCED ACNE CLARIFYING SYSTEM***Manufactured by: Quasar Biotech, Inc., BPP101 LAB-003-E, ***Made in the USA with highest quality components and durable aluminum. Five Year Warranty.***"
FDA Enforcement
Class II
·Terminated·Quasar Bio-Tech, Inc. dba Silver Bay LLC·December 19, 2012
MRI LED Mobile Exam Light Battery REF SL-111 This non-magnetic UL and CE approved battery is used in conjunction with SL-110, Mobile Exam Light
FDA Enforcement
Class II
·Ongoing·MRIMed Inc.·March 4, 2026
Sony LMD-1951MD, Sony LMD1951MD/BS, Sony LMD-1951MC (Foreign) 19 inch medical grade liquid crystal display (LCD) Medical Monitors with light-emitting diode (LED) backlight technology.
FDA Enforcement
Class II
·Terminated·Sony Medical Systems·September 23, 2015