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18,261 catalysts · 4,728 grant · 3,126 8k filing · 2,639 approval · 2,188 device 510k · 1,786 device recall · 1,536 device pma
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18,261 catalysts · 4,728 grant · 3,126 8k filing · 2,639 approval · 2,188 device 510k · 1,786 device recall · 1,536 device pma
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: DJG. Advisory committee: Clinical Toxicology. Type: Traditional
Product code: NFT. Advisory committee: Clinical Toxicology. Type: Traditional
Product code: FIE. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: PBH. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: HWC. Advisory committee: Orthopedic. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: HSX. Advisory committee: Orthopedic. Type: Traditional
Product code: MAX. Advisory committee: Orthopedic. Type: Traditional
Supplement type: 30-Day Notice. Product code: NIQ. Advisory committee: CV. Decision: OK30
Product code: HRS. Advisory committee: Orthopedic. Type: Special
Sponsor: NOVARTIS. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: TG THERAPEUTICS, INC. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: TG THERAPEUTICS, INC. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: GENENTECH INC. Form: INJECTABLE. Route: INJECTION
Sponsor: GENENTECH INC. Form: INJECTABLE. Route: INJECTION
Sponsor: Lundbeck Seattle BioPharmaceuticals, Inc.. Form: INJECTABLE. Route: INJECTION
Supplement type: 30-Day Notice. Product code: PFN. Advisory committee: NE. Decision: OK30
Supplement type: 30-Day Notice. Product code: NPS. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NJL. Advisory committee: OR. Decision: OK30
Supplement type: 30-Day Notice. Product code: MOZ. Advisory committee: OR. Decision: OK30
Supplement type: 30-Day Notice. Product code: NKM. Advisory committee: CV. Decision: OK30
ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-02, H749396118000 — Reason: Certain desiccant tube subassemblies were built with end caps that were not correctly tightened. — Status: Ongoing
AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R. — Reason: Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard." — Status: Ongoing
CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 ¿m — Reason: Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch. — Status: Ongoing
Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000 — Reason: Certain desiccant tube subassemblies were built with end caps that were not correctly tightened. — Status: Ongoing
EverPatch+, REF: 1044002, Permanent Scleral Reinforcement Matrix 1x5.0mm x 8.5 mm Shield/1 x 5.0mm x 6.5 mm Rectangle, STERILE VH202 — Reason: Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch. — Status: Ongoing
AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R. — Reason: Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard." — Status: Ongoing
Product code: OBP. Advisory committee: Neurology. Type: Traditional
Product code: JOW. Advisory committee: Cardiovascular. Type: Traditional
Product code: DZE. Advisory committee: Dental. Type: Traditional
Product code: LZA. Advisory committee: General Hospital. Type: Abbreviated
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: OLO. Advisory committee: Neurology. Type: Traditional
Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION
Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION
Supplement type: 30-Day Notice. Product code: NVN. Advisory committee: CV. Decision: OK30
Supplement type: Real-Time Process. Product code: NIQ. Advisory committee: CV. Decision: APPR
Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 455071P Product Description: Greiner VACUETTE Blood Collection Tube with Clot Activator and Gel Separator and Standard Stopper (16 x 100 mm, 8ml) — Reason: Some of the Vacuette¿ CAT Serum Separator Clot Activator tubes were manufactured without gel separator, which could yield erroneous assay results and require the patient to return to the lab for recollection or repeat testing. This may result in delayed diagnosis, cause a delay in clinical decision-making or treatment and in some rare cases, yield incorrect results from less stable parameters. — Status: Ongoing
Product code: MAI. Advisory committee: Orthopedic. Type: Traditional
Product code: QSM. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: KGO. Advisory committee: General, Plastic Surgery. Type: Abbreviated
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Special
Product code: QSM. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: QSM. Advisory committee: Gastroenterology, Urology. Type: Traditional
0.9% Sodium Chloride Injection USP, L 8000, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7800-00. — Reason: Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites. — Status: Ongoing
Carvedilol Tablets, USP, 12.5 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430. NDC 68462-164-05 — Reason: CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level. — Status: Ongoing
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain. Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands. NDC 82009-032-10 — Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. — Status: Ongoing
Carvedilol Tablets, USP, 25 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 47430 NDC: 68462-165-05 — Reason: CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm — Status: Ongoing