Chicago-Area Physician Charged with Unlawfully Using Veterinary Catheters During Intrauterine Inseminations on Patients

… /chicago-area-physician-charged-unlawfully-using-veterinary-catheters-during-intrauterine … Department of Justice U.S. Attorney’s Office … physician unlawfully used veterinary catheters to perform intrauterine inseminations on his patients, according to a …

Tenderneeds Fertility LLC - 603383 - 04/13/2020

… importer of devices and a manufacturer of several types of Intrauterine Insemination (IUI) and Intracervical … classified under 21 CFR 884.6110, Assisted Reproduction Catheters are class II, prescription devices that require … in your firm’s IUI kits intended for use in human intrauterine insemination. • Based on evidence collected …

December 2022 510(K) Clearances

… CA 95050 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Rejoni Intrauterine Catheter Rejoni, Inc. 510(k) NO: K222798 … FROM FDA DEVICE: Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters Spectranetics Inc. 510(k) NO: K222837 (Special) …

Significant Risk and Nonsignificant Risk Medical Device Studies - Information Sheet

… and/or Accessories • Conventional General Hospital Catheters (long-term percutaneous, implanted, subcutaneous … Electrical Neuromuscular Stimulators • General Biliary Catheters • General Urological Catheters (e.g., Foley and … Vitro Diagnostics (IVDs) o Diaphragms o Female Condoms o Intrauterine Devices (IUDs) o New Electrosurgical Instruments …

EIR dated 06/04/2001 - 06/08/2001; (size 209KB)

… the cause of the adverse events associated with firm's Intrauterine Pressure monitors. The inspection revealed no … was not being performed to demonstrate that IUP-400 Catheters met all applicable device specifications. The last … Reports 9. Device Master Record for Intran Sensor Tipped Catheters page 15 page 16 Utah Medical Products, Inc. 7043 …

Nitinol: Medical Device Material Safety Summary

… transvenous pacemakers. For peripherally inserted central catheters, moderate-quality evidence from 1 study reported … malfunction/breakage as a local device event. 15. For intrauterine devices, low-quality evidence from 1 study … from 3 to 12 months. f. Peripherally inserted central catheters i. One RCT comparing a nitinol and non-nitinol PICC …

Dracker_05.19.21ConsentCV_508

… Aggressive Plasmapheresis, IV-IgG Therapy and Percutaneous Intrauterine Umbilical Transfusion in a Patient with Severe … K, DeHority L, Pontello P: Comparison of Apheresis Access Catheters, American Society for Apheresis, Boston … Successful Aggressive Plasmapheresis, IV-lgG Therapy and Intrauterine Transfusions in a Patient with Severe RH­ …

Robert Dracker New_CV

… Aggressive Plasmapheresis, IV-lgG Therapy and Percutaneous Intrauterine Umbilical Transfusion in a Patient with Severe … K, DeHority L, Pontello P: Comparison of Apheresis Access Catheters, American Society for Apheresis, Boston … Successful Aggressive Plasmapheresis, IV-IgG Therapy and Intrauterine Transfusions in a Patient with Severe RH­ …

Regulation of Medical Devices - Transcript

… those were heart valves, pace makers, intraocular lens and intrauterine devices. And at that time they were kind of in a … lenses, endoscopes, dental filling material, some types of catheters, some TENS devices, that transcutaneous electrical … significant risk devices. The various types of vascular catheters, anesthesia machines, some other types of catheters …