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10,064 catalysts · 3,189 8k filing · 2,091 grant · 1,128 approval · 1,000 device adverse event · 848 device 510k · 610 device pma
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10,064 catalysts · 3,189 8k filing · 2,091 grant · 1,128 approval · 1,000 device adverse event · 848 device 510k · 610 device pma
10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029. 850 bulk non-sterile units per case. — Reason: During the bulk packaging process, some Luer Slip syringes were incorrectly included in a batch designated for Luer Lok syringes. — Status: Ongoing
CLARITY II Laser System; Model No. 1110200210. — Reason: Reports of devices sparking/popping and potentially burning patients. — Status: Ongoing
AI grant. $43,914. PI: Adrianna M. Rivera-León
NS grant. $625,859. PI: Rujuta Bhatt Wilson
AI grant. $780,787. PI: Gregoire Stephane Lauvau
Sponsor: PF PRISM CV. Form: TABLET. Route: ORAL
Sponsor: PF PRISM CV. Form: POWDER. Route: INTRAVENOUS
Sponsor: PF PRISM CV. Form: FOR SUSPENSION. Route: ORAL
Sponsor: HIKMA. Form: SOLUTION. Route: ORAL
Sponsor: HIKMA. Form: SOLUTION. Route: ORAL
Sponsor: VISUS. Form: SOLUTION/DROPS. Route: OPHTHALMIC
Sponsor: LUPIN LTD. Form: TABLET. Route: ORAL
Sponsor: MYLAN INSTITUTIONAL. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: TARO. Form: CAPSULE. Route: ORAL
Sponsor: OTSUKA PHARM CO LTD. Form: FOR SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR
Sponsor: AMNEAL. Form: CAPSULE. Route: ORAL
Sponsor: UNICHEM. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: UNICHEM. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: DPT Laboratories, Ltd., 307 E Josephine Street, San Antonio, TX 78215. NDC: 76282-103-39 — Reason: Failed PH Specifications — Status: Ongoing
Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1592-07 — Reason: Subpotent Drug: Due oxidation caused by leakage of the contents of the Icosapent Ethyl 1g capsules. Use of the affected product may lead to inconsistent therapeutic effects and an increase in potential gastrointestinal side effects in some patients. — Status: Ongoing
Furosemide Tablets, USP 40 mg, 1,000 Tablets, Rx Only, Manufactured for: Rising Pharmaceuticals Inc., East Brunswick, NJ 08816, Manufactured by: Graviti Pharmaceuticals Pvt. Ltd. Telangana - 502307, India, NDC 64980-563-10. — Reason: Presence of Foreign Substance — Status: Ongoing
Thyroid, USP, Rx only, Net Wt: 0.50kg, For Manufacturing, Processing or Repackaging Use Only, Specialty Process Labs, Phoenix, AZ 85034, NDC 81305-100-02 — Reason: Subpotent Drug — Status: Ongoing
Product code: QKB. Advisory committee: Radiology. Type: Traditional
Product code: IRP. Advisory committee: Physical Medicine. Type: Traditional
Product code: FRG. Advisory committee: General Hospital. Type: Traditional
Product code: DRT. Advisory committee: Cardiovascular. Type: Special
Product code: FRN. Advisory committee: General Hospital. Type: Traditional
Product code: DQK. Advisory committee: Cardiovascular. Type: Traditional
Product code: LYK. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: MBI. Advisory committee: Orthopedic. Type: Special
Product code: NDN. Advisory committee: Orthopedic. Type: Traditional
Product code: OBH. Advisory committee: Cardiovascular. Type: Traditional
Product code: ELC. Advisory committee: Dental. Type: Traditional
Product code: OUR. Advisory committee: Orthopedic. Type: Traditional
Product code: LPH. Advisory committee: Orthopedic. Type: Traditional
Supplement type: Special (Immediate Track). Product code: EZY. Advisory committee: GU. Decision: APPR
Supplement type: Special (Immediate Track). Product code: MVC. Advisory committee: PA. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: SGV. Advisory committee: SU. Decision: APPR
Supplement type: 30-Day Notice. Product code: QPY. Advisory committee: PM. Decision: OK30
Supplement type: 135 Review Track For 30-Day Notice. Product code: NIM. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: LMF. Advisory committee: SU. Decision: OK30
Supplement type: 30-Day Notice. Product code: NVZ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MCN. Advisory committee: OB. Decision: OK30
Supplement type: 30-Day Notice. Product code: POH. Advisory committee: NE. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: NPV. Advisory committee: CV. Decision: APPR
Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011. — Reason: Composite polisher cups may crumble and break apart easily, which could cause a delay in patient treatment. — Status: Ongoing
Medline Medcrest Surgical Gowns: MDTGXC4J5XL DBQ-GOWN,SURG,XALT,L4, CRTCL CVR, GRN, 5 MDTGXC4JL DBD-GOWN,SURG,XALT,L4,CRTCL CVR,GREEN,L MDTGXC4JXL DBD-GOWN,SURG,XALT,L4,CRTCL CVR,GREEN,XL MDTGXC4JXXL DBD-GOWN,SURG,XALT,L4,CRTCL CVR,GREEN,XX MDTGXP4JL DBD-GOWN,SURG,XALT,L4,PANEL CVR,GREEN,L MDTGXP4JXL DBD-GOWN,SURG,XALT,L4,PANEL CVR,GREEN,XL MDTGXP4JXXL DBD-GOWN,SURG,XALT,L4,PANEL CVR,GREEN,XX MDTL1002862EF DBD-GOWN,SURG,XALT,L4,PANEL CVR,GREEN,XL MDTZ1000893AJ DBD-GOWN,SRG,PNL CVR, GREEN,SNPS,XL — Reason: Fabric may experience premature delamination when using included laundering instructions. Identifying delaminated gown or drape in a surgical setting may result in brief delay in patient care. If delaminated product is used and surgical strikethrough occurs, there may be risk of infection. — Status: Ongoing
Medline Surgical Drapes: MDTBTCS6070GN DBD-DRAPE,COVER,TABLE,RESIS/XALT GRN,60X MDTBTCS6090GN DBD-DRAPE,COVER,TABLE,RESIS/XALT GRN,60X MDTDXUNDBGN DBD-DRAPE,UNDERBUTTOCK,28 X 50.5,XALT GR MDTMAYOXGN DBD-DRAPE,COVER,MAYO STAND,RESISTAT/XALT MDTZ1003656GN DBD-POCKET SHEET,RESISTAT/XALT — Reason: Fabric may experience premature delamination when using included laundering instructions. Identifying delaminated gown or drape in a surgical setting may result in brief delay in patient care. If delaminated product is used and surgical strikethrough occurs, there may be risk of infection. — Status: Ongoing
AI grant. $921,320. PI: Michaelle Chojnacki