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10,210 catalysts · 3,124 8k filing · 2,098 grant · 1,170 approval · 1,000 device adverse event · 885 device 510k · 633 device pma
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10,210 catalysts · 3,124 8k filing · 2,098 grant · 1,170 approval · 1,000 device adverse event · 885 device 510k · 633 device pma
Sponsor: RUBICON RESEARCH. Form: TABLET. Route: SUBLINGUAL
Sponsor: TARO. Form: TABLET. Route: ORAL
Sponsor: MANKIND PHARMA. Form: CAPSULE. Route: ORAL
Sponsor: LGM PHARMA. Form: TABLET. Route: ORAL
Product code: GXP. Advisory committee: Neurology. Type: Special
Product code: EZD. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: INI. Advisory committee: Physical Medicine. Type: Traditional
Product code: OWX. Advisory committee: General, Plastic Surgery. Type: Special
Supplement type: 30-Day Notice. Product code: FTR. Advisory committee: SU. Decision: OK30
Supplement type: 30-Day Notice. Product code: LNM. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: QZI. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: FTR. Advisory committee: SU. Decision: OK30
Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01. — Reason: Tyvek bag seal issue which may compromise sterility of the kit. — Status: Ongoing
ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 267-01-000-10-N UDI-DI code: 00190376541471; GMDN 12844 The ATEC Navigation Disc Prep Instruments are intended for use in surgical procedures. These instruments are non-sterile or sterile packaged, re-usable or single-use instruments designed to function with the Medtronic StealthStation System and NavLock Tracker. — Reason: Due a design issue where the navigated array connection geometry is incorrect. — Status: Ongoing
ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 266-01-000-10-N UDI-DI code: 00190376476179; GMDN 12844 The ATEC Navigation Disc Prep Instruments are intended for use in surgical procedures. These instruments are non-sterile or sterile packaged, re-usable or single-use instruments designed to function with the Medtronic StealthStation System and NavLock Tracker. — Reason: Due a design issue where the navigated array connection geometry is incorrect. — Status: Ongoing
NS grant. $42,647. PI: Colista Sue West
Sponsor: RISING. Form: TABLET. Route: ORAL
Sponsor: SANDOZ INC. Form: FOR SUSPENSION. Route: ORAL
Sponsor: GLENMARK PHARMS LTD. Form: SUSPENSION. Route: ORAL
Sponsor: ZYDUS PHARMS. Form: INJECTABLE. Route: INJECTION
Sponsor: ACTAVIS ELIZABETH. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: AMNEAL PHARMS. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Product code: LTJ. Advisory committee: Immunology. Type: Traditional
Product code: FXX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: QJP. Advisory committee: Cardiovascular. Type: Traditional
Product code: IYE. Advisory committee: Radiology. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: FRO. Advisory committee: Unknown. Type: Traditional
Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: LTI. Advisory committee: GU. Decision: APPR
Product code: LPB. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NIK. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWQ. Advisory committee: CV. Decision: OK30
VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem/Vaborbactam (mev01n) o Imipenem (ipm05n) o Imipenem/Relebactam (ipr01n); CARD NAME/ PRODUCT REFERENCE: AST-N399 423701 AST-N402 423644 AST-N403 423645 AST-N404 423664 AST-N405 423864 AST-N406 423869 AST-N407 423870 AST-N409 423925 AST-N412 423936 AST-N413 423928 AST-N414 423933 AST-N415 423934 AST-N416 423935 AST-N417 423880 AST-N419 423948 AST-N421 424055 AST-N428 424320 AST-N429 424321 AST-N430 424322 AST-N433 424389 AST-N439 424501 AST-N440 424502 AST-N443 424541 AST-N444 424587 AST-N467 424857 AST-N476 424934 AST-N478 425052 AST-N480 425084 AST-N481 425085 AST-N485 425182 AST-N496 425265 AST-N800 423310 AST-N802 423706 AST-N804 424634 AST-N808 424711 AST-N810 424712 AST-N811 424713 AST-N813 424722 AST-N815 425054 AST-XN09 423425 AST-XN15 423829 AST-XN17 423673 AST-XN18 423874 AST-XN20 423947 AST-XN21 424197 AST-XN22 424199 AST-XN23 424198 AST-XN24 424351 AST-XN26 424500 AST-XN28 424586 AST-XN29 424604 AST-XN30 424639 AST-XN31 424640 AST-XN32 424678 AST-XN33 424723 AST-XN34 424752 AST-XN35 424810 AST-XN36 424860 AST-XN37 424888 AST-XN38 425074 AST-XN39 425086 AST-XN40 425095 AST-XN41 425204 AST-XN42 425309 — Reason: Potential risk of Quality Control failures and/or false resistant antibiotic results when testing isolates of Enterobacterales/Enterobacteriaceae species and/or Pseudomonas aeruginosa with the identified antibiotic formulations. Issue may lead to QC failure or false resistant results. — Status: Ongoing
Raz-AT (Attendant Tilt) Mobile Shower Commode Chair, Catalog Number Z300 UDI-DI code: (01)00628758003007 Raz-ART (Attendant Rotational Tilt) Mobile Shower Commode Chair, Catalog Number Z333 UDI-DI code: (01)00628758003335 Raz-AT600 (Bariatric Tilt) Mobile Shower Commode Chair, Catalog Number Z360 UDI-DI code: (01)00628758003601 Raz-SP (Self Propel) Mobile Shower Commode Chair, Catalog Number Z200 UDI-DI code: (01)00628758001003 Raz-AP (Attendant Propel) Mobile Shower Commode Chair, Catalog Number Z100 UDI-DI code: (01)00628758001003 The Raz Mobile Shower Commode Chair is intended to be used by people with mobility impairments, who may have difficulty in standing or keeping their balance while completing activities such as showering, toileting, or personal hygiene. — Reason: Due to a modification by a vendor and may be reinstalled without properly engaging the outside rear seat brackets that are used to keep the seat in place. — Status: Ongoing
Medline Convenience Kits: 1) NAIL KIT, Model Number: DYKM1528 — Reason: Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products. — Status: Ongoing
Meijer STERILE saline wound wash, First Aid Cleansing Spray, 0.9% USP SODIUM CHLORIDE, 7.1FL OZ (210 mL), DBD-CAN,SPRAY,7.1-OZ,SALINE,WOUND WASH,S, Model Number MJSALINE7 — Reason: Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products. — Status: Ongoing
EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705 — Reason: 942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery. — Status: Ongoing
Medline Sterile Saline Wound Wash, Cleansing & Wound Irrigation, USP Normal Saline (0.9% Sodium Chloride), 7.1 FL OZ (210 mL), DBD-CAN,SPRAY,7.1-OZ,SALINE,WOUND WASH,S, Model Number MDSALINE7 — Reason: Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products. — Status: Ongoing
Medline Convenience Kits: 1) TRUNK KIT W/EXPIRATION, Model Number: DYKM1361A; 2) TRUNK KIT 1EA, Model Number: DYKM2013; 3) TRUNK KIT 1EA, Model Number: DYKM2013A; 4) RN TRUNK KIT, Model Number: DYKM2699; 5) TRUNK KIT, Model Number: DYKTRUNK1 — Reason: Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products. — Status: Ongoing
EMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, REF: 942-01-36H; Liner, 10 degree Hooded, HXe+, 36J, REF: 942-01-36J; Liner, 10 degree Hooded, HXe+, 40G, REF: 942-01-40G; Liner, 10 degree Hooded, HXe+, 32C, REF: 942-01-32C — Reason: 942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery. — Status: Ongoing
Medline Convenience Kits: 1) NAIL KIT, Model Number: POD14214 — Reason: Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products. — Status: Ongoing
NS grant. $33,538. PI: SEAN COLLIER
Sponsor: GLAND. Form: SOLUTION/DROPS. Route: OPHTHALMIC
Sponsor: UPSHER SMITH LABS. Form: SUSPENSION/DROPS. Route: OTIC
Sponsor: HIKMA. Form: SOLUTION. Route: ORAL
Sponsor: HIKMA. Form: SOLUTION. Route: ORAL
Sponsor: HIKMA. Form: SOLUTION. Route: ORAL