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12,251 catalysts · 3,603 8k filing · 2,283 grant · 1,771 approval · 1,164 device 510k · 1,000 device adverse event · 848 device pma
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12,251 catalysts · 3,603 8k filing · 2,283 grant · 1,771 approval · 1,164 device 510k · 1,000 device adverse event · 848 device pma
PRISMAFLEX ST150 SET US, Product Code 107640US; Dialyzer, High Permeability With Or Without Sealed Dialysate System — Reason: There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. — Status: Ongoing
WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM — Reason: The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown. — Status: Ongoing
PRISMAFLEX HF1000 SET, Product Code 107142; Dialyzer, High Permeability With Or Without Sealed Dialysate System — Reason: There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. — Status: Ongoing
DA grant. $49,538. PI: Lily Torp
NS grant. $74,632. PI: THADDEUS KUNKEL
NS grant. $50,000. PI: Huaye Zhang
Sponsor: ELI LILLY AND CO. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: ELI LILLY AND CO. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: ACCORD HLTHCARE. Form: TABLET. Route: ORAL
Sponsor: HEBEI CHANGSHAN. Form: INJECTABLE. Route: SUBCUTANEOUS
Sponsor: EPIC PHARMA LLC. Form: TABLET. Route: ORAL
Sponsor: BIOCON BIOLOGICS INC. Form: INJECTABLE. Route: INJECTION
Sponsor: HUMANWELL. Form: TABLET. Route: ORAL
Sponsor: HUMANWELL. Form: TABLET. Route: ORAL
Sponsor: MYLAN. Form: TABLET. Route: ORAL-28
Sponsor: MICRO LABS LTD INDIA. Form: TABLET. Route: ORAL
Sponsor: INNOGENIX. Form: TABLET. Route: ORAL
traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufactured by: Zydus Lifesciences Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-806-10 — Reason: Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface. — Status: Ongoing
Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercards each containing 10 tablets), Rx only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-157-13 — Reason: Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale. — Status: Ongoing
Wegovy (semaglutide) Injection, 1 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark, Product of Denmark, Novo Nordisk A/S, Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-4501-14 — Reason: Presence of Particulate Matter: Hair was found in a prefilled syringe — Status: Ongoing
Wegovy (semaglutide) Injection, 0.5 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark, Product of Denmark, Novo Nordisk A/S, Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-4505-14 — Reason: Presence of Particulate Matter: Hair was found in a prefilled syringe — Status: Ongoing
BD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG), 2% w/v and Isopropyl alcohol (IPA), 70% v/v), 5.25 mL Applicator, CareFusion 213, LLC, El Paso, TX 79912, NDC 54365-401-29 — Reason: Lack of Assurance of Sterlity — Status: Ongoing
Product code: KIF. Advisory committee: Dental. Type: Traditional
Product code: QAU. Advisory committee: General, Plastic Surgery. Type: Special
Product code: PHN. Advisory committee: Unknown. Type: Special
Product code: MYN. Advisory committee: Radiology. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: BZD. Advisory committee: Anesthesiology. Type: Special
Product code: QAS. Advisory committee: Radiology. Type: Traditional
Product code: PPT. Advisory committee: Neurology. Type: Special
Product code: NXC. Advisory committee: Dental. Type: Traditional
Product code: PNE. Advisory committee: Cardiovascular. Type: Traditional
Product code: QEW. Advisory committee: Cardiovascular. Type: Traditional
Product code: NHA. Advisory committee: Dental. Type: Traditional
Product code: MQP. Advisory committee: Orthopedic. Type: Traditional
Product code: NKB. Advisory committee: Orthopedic. Type: Special
Product code: NKB. Advisory committee: Orthopedic. Type: Special
Product code: DQA. Advisory committee: Cardiovascular. Type: Traditional
Product code: PNN. Advisory committee: Dental. Type: Traditional
Supplement type: 30-Day Notice. Product code: NIP. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: SDA. Advisory committee: AN. Decision: OK30
Supplement type: 30-Day Notice. Product code: QON. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: QWN. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: EZW. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: LPM. Advisory committee: OP. Decision: OK30
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current. — Reason: Devices which did not undergo thermoforming could deform and lose performance. — Status: Ongoing
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current. — Reason: Devices which did not undergo thermoforming could deform and lose performance. — Status: Ongoing
Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84A; 2) KIT SURG ONC EXPLORATORY LAP, Model Number: DYKMBNDL87A; 3) CT BIOPSY TRAY, Model Number: DYNDH1143C; 4) BIOPSY SPECIALS PACK, Model Number: DYNDH1873; 5) BIOPSY SPECIALS PACK, Model Number: DYNDH1934; 6) BREAST BIOPSY PACK, Model Number: DYNJ17489I; 7) VOR PACK-LF, Model Number: DYNJ48539; 8) VOR PACK-LF, Model Number: DYNJ48539A; 9) IR BIOPSY PACK, Model Number: DYNJ59897B; 10) BREAST PACK, Model Number: DYNJ82998 — Reason: Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products. — Status: Ongoing
Medline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM1031A — Reason: Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products. — Status: Ongoing
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0330; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current. — Reason: Devices which did not undergo thermoforming could deform and lose performance. — Status: Ongoing