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

… — A Chicago-area physician unlawfully used veterinary catheters to perform intrauterine inseminations on his patients, according to a … Affairs … FDA OCI, Joel Brasch, MD, veterinary catheters, intrauterine, insemination, patients, human, adulterated, …

506J Device List

… Anesthesia Masks BSJ MASK, GAS, ANESTHETIC Angioplasty Catheters DRB STYLET, CATHETER DYB INTRODUCER, CATHETER ONU … Monitors GWM DEVICE, MONITORING, INTRACRANIAL PRESSURE Intrauterine Tamponade Balloon OQY INTRAUTERINE TAMPONADE BALLOON Intravenous (IV) Containers …

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 …

GHPUDP Feb. 6, 2024 Proposed 506J Device List

… Anesthesia Masks BSJ MASK, GAS, ANESTHETIC Angioplasty Catheters DRB STYLET, CATHETER DYB INTRODUCER, CATHETER ONU … Monitors GWM DEVICE, MONITORING, INTRACRANIAL PRESSURE Intrauterine Tamponade Balloon OQY INTRAUTERINE TAMPONADE BALLOON Page 6 of 11 …

GHPUDP Feb. 6, 2024 Presentation (FDA)

… Examples: N95 respirators, masks, syringes & needles, catheters, PPE The FDA considers these devices vulnerable to … • Device types include those used for fetal monitoring and intrauterine dilation, as well as those used to perform diagnostic imaging • Fetal monitoring and intrauterine dilation • Fetal monitors and intrauterine …

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 …

Robert Dracker_New CV

… 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-IgG 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 …

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 …

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 …