17 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FOUNDATION KNEE AUGMENTATION BLOCKS
FDA 510(k)
FDA Class 2
·Orthopedic
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471122987·K-WIRE - SINGLE TROCAR 1.25mm DIA x 150mm
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471193444·K-WIRE - SINGLE TROCAR 3.0mm DIA x 150mm
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471150737·K-WIRE - SINGLE TROCAR 1.0mm DIA x 150mm
TEVADAPTOR; CONNECTING SET W/ ULTRASITE INJECTION SITE, SPIKE PORT ADAPTOR SET W/ ULTRASITE INJECTION SITE
FDA 510(k)
FDA Class 2
·General Hospital
NUMED PTS X SIZING BALLOON CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
UNICEL® DXI 600 ACCESS® IMMUNOASSAY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·December 29, 2010
3874 1X8 COMPACT TRIAL LEAD
FDA Adverse Event
Malfunction
·NEURO - VILLALBA·Product code LGW·February 4, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 17, 2014
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 Recall
Terminated
·Quasar Bio-Tech, Inc. dba Silver Bay LLC·Product code ILY·October 25, 2012
Quasar MD is an infrared LED lamp that is labeled in part: "***QUASAR MD***Bringing the Spa Home***Radiant and Youthful Skin***QUASAR MD INCLUDES***QUASAR MD***USER MANUAL***12 VOLT POWER SUPPLY***1 OZ PURE SILK SERUM***Made in the USA.***Five year warranty***" The product emits energy in the near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature. This device may be used to provide temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm. This device may temporarily increase local blood circulation, and may be used to promote relaxation of the muscle tissue.
FDA Recall
Terminated
·Quasar Bio-Tech, Inc. dba Silver Bay LLC·Product code ILY·October 25, 2012
Baby Quasar (LAB-001-D, BQ101) and Baby Quasar Pink (LAB-046-A BQ101-P) are infrared LED lamps that are labeled in part: "***BABY QUASAR***FOR YOUTHFUL RADIANT SKIN***Skin Rejuvenating System with Sequepulse***Manufactured by: Silver Bay, LLC; Made in the USA, with highest quality components and durable aluminum. Five Year Warranty The product emits energy in the near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature. This device may be used to provide temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm. This device may temporarily increase local blood circulation, and may be used to promote relaxation of the muscle tissue.
FDA Recall
Terminated
·Quasar Bio-Tech, Inc. dba Silver Bay LLC·Product code ILY·October 25, 2012
Baby Quasar Plus, Light Therapy System, packaging, box, sleeve and user manual. Handheld Wrinkles Reduction Device.
FDA Recall
Terminated
·Quasar Bio-Tech, Inc.·Product code OHS·June 29, 2018
Pure Rayz, Light Therapy System, packaging, box, sleeve and user manual. Handheld Wrinkles Reduction Device.
FDA Recall
Terminated
·Quasar Bio-Tech, Inc.·Product code OHS·June 29, 2018
Quasar MD Plus, Light Therapy System, packaging, box, sleeve and user manual. Handheld Wrinkles Reduction Device.
FDA Recall
Terminated
·Quasar Bio-Tech, Inc.·Product code OHS·June 29, 2018
ev3 Pipeline Flex Embolization Device. For neurological endovascular use.
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·April 1, 2020
Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the 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. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation
FDA Enforcement
Class II
·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013