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18,463 catalysts · 4,728 grant · 3,350 8k filing · 2,638 approval · 2,182 device 510k · 1,778 device recall · 1,529 device pma
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18,463 catalysts · 4,728 grant · 3,350 8k filing · 2,638 approval · 2,182 device 510k · 1,778 device recall · 1,529 device pma
Vial Label: Epinephrine Injection, USP, 1mg/10mL (0.1 mg/mL), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045, USA. NDC 0409-4933-05. Case: NDC 0409-4933-10. — Reason: Lack of Assurance of Sterility. — Status: Ongoing
Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), Rx only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-6637-24. Case NDC: 00409-6637-14. — Reason: Lack of Assurance of Sterility. — Status: Ongoing
Tavaborole Topical Solution 5%, 10 mL per glass bottle, Rx Only, For Topical Use Only, Manufactured by: Zydus Lifesciences Ltd., Changodar Ahmedabad, India. Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016. NDC: 72578-102-04 — Reason: Discoloration — Status: Ongoing
Carvedilol Tablets USP, 12.5 mg, 100- Tablets, (10x10) cartons, Rx Only, Packaged and distributed by Major Pharmaceuticals, Indianapolis, IN, 46268, USA, NDC 0904-7307-61 — 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
BZK Antiseptic Towelette, Sterile, For External Use Only, benzalkonium chloride 0.13%, Antiseptic, 100 towelettes per carton , For Professional use, Mfg by: Taizhou Kangping Medical, Taizhou, JiangSu, China, NDC: 71310-111-01 — Reason: Lack of Assurance of Sterility. — Status: Ongoing
Product code: NXC. Advisory committee: Dental. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: HRX. Advisory committee: Orthopedic. Type: Traditional
Product code: CAW. Advisory committee: Anesthesiology. Type: Traditional
Product code: OCT. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: QME. Advisory committee: Cardiovascular. Type: Traditional
Product code: EOQ. Advisory committee: Ear, Nose, Throat. Type: Traditional
Supplement type: Real-Time Process. Product code: MKJ. Advisory committee: CV. Decision: APPR
Product code: QZI. Advisory committee: CV. Decision: APPR
Supplement type: Special (Immediate Track). Product code: LNM. Advisory committee: GU. Decision: APPR
Supplement type: Real-Time Process. Product code: LWS. Advisory committee: CV. Decision: APPR
Supplement type: Panel Track. Product code: NPT. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: DSQ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MKQ. Advisory committee: PA. Decision: OK30
Supplement type: Real-Time Process. Product code: NVN. Advisory committee: CV. Decision: APPR
Supplement type: Real-Time Process. Product code: NIK. Advisory committee: CV. Decision: APPR
The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement. — Reason: Vision RT is informing customers of an omission identified in the Instructions for Use for AlignRT InBore systems. Information identifying the lasers and their characteristics was omitted from the Instructions for Use for the subject system as required by 21 CFR 1040,10(h), via conformance with recognized consensus standard IEC 60825-1 Ed. 3 (FDA Laser Notice 56). — Status: Ongoing
Product code: HGM. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: NFT. Advisory committee: Clinical Toxicology. Type: Traditional
Product code: HWC. Advisory committee: Orthopedic. Type: Traditional
Product code: LZA. Advisory committee: General Hospital. Type: Traditional
Product code: FRO. Advisory committee: Unknown. Type: Traditional
Product code: MQL. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: MWI. Advisory committee: Cardiovascular. Type: Traditional
Product code: DXF. Advisory committee: Cardiovascular. Type: Traditional
Product code: QOF. Advisory committee: Microbiology. Type: Traditional
Product code: JWY. Advisory committee: Microbiology. Type: Traditional
Product code: NUH. Advisory committee: Neurology. Type: Special
Product code: CCK. Advisory committee: Anesthesiology. Type: Traditional
Product code: KWQ. Advisory committee: Orthopedic. Type: Traditional
Product code: JAK. Advisory committee: Radiology. Type: Traditional
Product code: QEW. Advisory committee: Cardiovascular. Type: Traditional
Product code: MNR. Advisory committee: Anesthesiology. Type: Special
Product code: NKB. Advisory committee: Orthopedic. Type: Special
Product code: PGY. Advisory committee: Radiology. Type: Abbreviated
Product code: LYZ. Advisory committee: General Hospital. Type: Traditional
Product code: PHX. Advisory committee: Orthopedic. Type: Special
Product code: NAY. Advisory committee: Gastroenterology, Urology. Type: Special
Product code: NGX. Advisory committee: Physical Medicine. Type: Special
Product code: CBK. Advisory committee: Anesthesiology. Type: Traditional
Product code: KPR. Advisory committee: Radiology. Type: Traditional
Product code: QOG. Advisory committee: General Hospital. Type: Traditional
Supplement type: 30-Day Notice. Product code: MHY. Advisory committee: NE. Decision: OK30
Supplement type: Special (Immediate Track). Product code: QQK. Advisory committee: GU. Decision: APPR
Supplement type: 30-Day Notice. Product code: NCD. Advisory committee: MI. Decision: OK30