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9,923 catalysts · 3,048 8k filing · 2,091 grant · 1,128 approval · 1,000 device adverse event · 848 device 510k · 610 device pma
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9,923 catalysts · 3,048 8k filing · 2,091 grant · 1,128 approval · 1,000 device adverse event · 848 device 510k · 610 device pma
Supplement type: 30-Day Notice. Product code: LMH. Advisory committee: SU. Decision: OK30
Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1 — Reason: During the manufacturing, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design. — Status: Ongoing
Laerdal Compact Suction Unit 4 RTCA version (LCSU 4 RTCA) 1) LCSU 4, 800 ml, RTCA; Catalog Number: 880052; 2) LCSU 4, 300 ml, RTCA; Catalog Number: 880062; 3) LCSU 4, RTCA; Catalog Number: 881152; — Reason: units manufactured in a limited time period may emit electromagnetic noise beyond the acceptable limits for RTCA application specified in RTCA DO-160G Chapter 21, Equipment Category M. — Status: Ongoing
Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 Software Version: N/A Product Description: Infusion Pump, one unit per carton Component: N/A — Reason: Pumps were released without full testing being performed, including occlusion alarm testing. — Status: Ongoing
DK grant. $450,479. PI: Zhijian Qian
Sponsor: TEVA PHARMS. Form: CAPSULE. Route: ORAL
Sponsor: TEVA PHARMS. Form: CAPSULE. Route: ORAL
Sponsor: KENVUE BRANDS. Form: AEROSOL, FOAM. Route: TOPICAL
Sponsor: MSN. Form: TABLET. Route: ORAL
Sponsor: AUROBINDO PHARMA LTD. Form: CAPSULE. Route: ORAL
Sponsor: KENVUE BRANDS. Form: SOLUTION. Route: TOPICAL
Sponsor: AMNEAL. Form: TABLET. Route: ORAL
Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION
Sponsor: CELLTRION INC. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: AUROBINDO PHARMA. Form: TABLET. Route: ORAL
Sponsor: LAURUS. Form: TABLET. Route: ORAL
Sponsor: NOVARTIS. Form: TABLET. Route: ORAL
Sponsor: LAURUS. Form: CAPSULE. Route: ORAL
Sponsor: SOMERSET THERAPS LLC. Form: TABLET
Sponsor: ZYDUS PHARMS. Form: TABLET. Route: ORAL
Sponsor: ORBICULAR. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: RISING. Form: TABLET. Route: ORAL
Sponsor: AUROBINDO PHARMA LTD. Form: TABLET, DELAYED RELEASE. Route: ORAL
Sponsor: KENVUE BRANDS. Form: SOLUTION. Route: TOPICAL
Sponsor: SANDOZ. Form: TABLET. Route: ORAL
Sponsor: ALEMBIC. Form: TABLET. Route: ORAL
Sponsor: PHARMACHEMIE BV. Form: INJECTABLE. Route: INJECTION
Sponsor: PHARMACHEMIE BV. Form: INJECTABLE. Route: INJECTION
Sponsor: RISING. Form: CAPSULE. Route: ORAL
ClearLife Allergy Nasal Spray, Extra Strength, 0.68 fl. oz. (20 mL) bottles, Distributed by: MediNatura, 10421 Research Rd., SE, Albuquerque, NM 87123, NDC 62795-4006-9, UPC 787647101887 — Reason: Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter. — Status: Ongoing
Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0523-01. — Reason: Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets. — Status: Ongoing
Tri-Moxi+¿ (Triamcinolone 9mg/0.6mL, Moxifloxacin 0.6 mg/ 0.6 mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852. NDC 71384-746-06. — Reason: Presence of particulate matter - Glass like particles. — Status: Ongoing
ReBoost Nasal Spray, 0.68 fl. oz. (20 mL) bottles, Distributed by: MediNatura, 10421 Research Rd., SE, Albuquerque, NM 87123, NDC 62795-4005-9, UPC 787647101863 — Reason: Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter. — Status: Ongoing
ORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz. (500ml) per bottle, ORL Labs, LLC, Scottsdale, Arizona USA — Reason: cGMP Deviations — Status: Ongoing
Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0522-01. Case label: SpecGx LLC, NDC 0406052201, Exp. 2027/03, Lot: 0522J23493 — Reason: Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets. — Status: Ongoing
ORL Kids Natural Toothpaste, Bubblegum Flavor, 4 oz (120ml), ORL Labs, LLC, Scottsdale, Arizona USA — Reason: cGMP Deviations — Status: Ongoing
Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 50268-709-15 — Reason: Out of specification for dissolution. — Status: Ongoing
Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-176-30 — Reason: Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit. — Status: Ongoing
Dexamethasone Moxifloxacin Ketorolac, 1 mg/mL, 0.5 mg/mL, 0.4 mg/mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-513-01. — Reason: Presence of particulate matter - Glass like particles. — Status: Ongoing
Dexamethasone Moxifloxacin, 1 mg/mL and 5 mg/mL, 1 mL Intraocular Injection, Rx only, Imprimis NJOF, LLC, Ledgewood, NJ 07852, NDC 71384-512-0.1 — Reason: Presence of particulate matter - Glass like particles. — Status: Ongoing
Product code: ODP. Advisory committee: Orthopedic. Type: Traditional
Product code: OXO. Advisory committee: Radiology. Type: Traditional
Product code: GXN. Advisory committee: Neurology. Type: Traditional
Product code: MOS. Advisory committee: Radiology. Type: Special
Product code: LZC. Advisory committee: General Hospital. Type: Traditional
Product code: IYE. Advisory committee: Radiology. Type: Special
Product code: QJI. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: BTT. Advisory committee: Anesthesiology. Type: Traditional
Product code: KRD. Advisory committee: Cardiovascular. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional