36 results
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51ms
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Sources: EU EUDAMED, US FDA
ONY BIOTECH INC.
FDA registration
ONY BIOTECH INC.·1 product·🇺🇸 United States
AerVia Neonatal Supraglottic Airway Device, Small, <1000g
FDA UDI
ONY Biotech Inc.·00361938122012·6-Pack of AerVia Neonatal Supraglottic Airway D...
AerVia Neonatal Supraglottic Airway Device, X-Large, 3500-5000g
FDA UDI
ONY Biotech Inc.·00361938122043·6-Pack of AerVia Neonatal Supraglottic Airway D...
AerVia Neonatal Supraglottic Airway Device, Large, 2000-3500g
FDA UDI
ONY Biotech Inc.·00361938122036·6-Pack of AerVia Neonatal Supraglottic Airway D...
AerVia Neonatal Supraglottic Airway Device, Variety
FDA UDI
ONY Biotech Inc.·00361938122050·AerVia Neonatal Supraglottic Airway Device, Var...
AerVia Neonatal Supraglottic Airway Device, Medium, 1000-2000g
FDA UDI
ONY Biotech Inc.·00361938122029·6-Pack of AerVia Neonatal Supraglottic Airway D...
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
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
Cook Medical Biodesign Dural Graft, REF C-DUR-7X10, REF G31091, Sterile
FDA Recall
Open, Classified
·Cook Biotech, Inc.·Product code GXQ·November 22, 2024
Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; and
FDA Recall
Open, Classified
·Cook Biotech, Inc.·Product code OWV·November 22, 2024
Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.
FDA Recall
Open, Classified
·Cook Biotech, Inc.·Product code KHJ·November 22, 2024
Trep-Chek Syphilis Test Kit, 960 tests, Catalog No. TP-960, Distributed by DiaSorin, Inc. 1951 Northwestern Ave, Stillwater, MN 55082-0285 USA. Manufactured by Phoenix Bio-Tech Corp., 6910 Kitimat Road, Unit #1, Mississauga, Ontario, Canada L5N 5M2.
FDA Recall
Terminated
·Diasorin Inc.·Product code LIP·March 16, 2005
Biodesign Fistula Plug C-FPS-0.2-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46374
FDA Recall
Open, Classified
·Cook Biotech, Inc.·Product code FTM·August 7, 2024
Biodesign Inguinal Hernia Graft C-IHM-10X15 - To reinforce soft tissues in the inguinal floor to repair inguinal hernias. Order Number (GPN): G46603
FDA Recall
Open, Classified
·Cook Biotech, Inc.·Product code FTM·August 7, 2024
Biodesign Recto-Vaginal Fistula Plug RVP-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46602
FDA Recall
Open, Classified
·Cook Biotech, Inc.·Product code FTM·August 7, 2024
Biodesign Fistula Plug C-FPS-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G54613
FDA Recall
Open, Classified
·Cook Biotech, Inc.·Product code FTM·August 7, 2024