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12,161 catalysts · 3,603 8k filing · 2,283 grant · 1,765 approval · 1,146 device 510k · 1,000 device adverse event · 827 device pma
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12,161 catalysts · 3,603 8k filing · 2,283 grant · 1,765 approval · 1,146 device 510k · 1,000 device adverse event · 827 device pma
Medline medical procedure convenience kits labeled as: 1) MEM MAXILLOFACIAL PACK-LF, Kit SKU DYNJ0660040R; 2) PLASTICS VCH, Kit SKU DYNJ39225K; 3) WT BREAST PACK, Kit SKU DYNJ46620I; 4) ENDO / AUG PACK, Kit SKU DYNJ59250I; 5) KMC PLASTIC/GEN PACK-LF, Kit SKU DYNJ65980J; 6) PLASTICS PACK, Kit SKU DYNJ68288A; 7) IMPLANT REMOVAL KIT, Kit SKU MNS13035; 8) PLASTICS PACK-LF, Kit SKU PHS41746D. — Reason: Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive. — Status: Ongoing
Medline medical procedure convenience kits labeled as: 1) MIDDLE EAR CDS, Kit SKU CDS984347O; 2) HEAD AND NECK CDS-LF, Kit SKU CDS984857N; 3) NECK PACK-LF, Kit SKU DYNJ0966130K; 4) NECKLINE PACK-LF, Kit SKU DYNJ51440B; 5) THYROID PACK, Kit SKU DYNJ58742J; 6) ENT I, Kit SKU DYNJ63781B; 7) NECK PACK, Kit SKU DYNJ82751B; 8) NOSE PACK, Kit SKU DYNJ82753C; 9) WMC COCHLEAR IMPLANT ADD ON, Kit SKU DYNJ907206G. — Reason: Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive. — Status: Ongoing
Conductivity Standard Solution Catalog/Model Numbers: 10001, 10011, 10021, 10032, 10040, 10040c, and 10041 Conductivity Standard Solutions are a secondary standard solution used for the calibration of conductivity cells together with conductivity meters — Reason: due to a defect associated with the conductivity values of the solution used to calibrate meters and result in the reporting of incorrect conductivity values for dialysate. — Status: Ongoing
Medline medical procedure convenience kits labeled as: CIRCUMCISION PACK, Kit SKU DYNJ16826O — Reason: Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive. — Status: Ongoing
Codman CereLink ICP Sensor Basic Kit. Catalog Number: 826850. The Codman CereLink ICP Sensor Basic Kit consists of the CereLink ICP Sensor (ICP Sensor) and a 14-gauge Tuohy needle with stylet. The ICP Sensor is a nylon tube with a microminiature strain gauge pressure transducer (sensing element) mounted at one end and an electrical connector at the other end. It is designed for use with a Codman intracranial pressure monitoring device. The ICP Sensor Basic Kit is designed for use with the Codman Cranial Hand Drill. The drill facilitates access to the intraparenchymal area. The drill is also available as a component of the Codman Cranial Access Kit. Use of the ICP Sensor Basic Kit is indicated when direct ICP monitoring is required. The kit is indicated for use in both subdural and intraparenchymal pressure monitoring applications only. — Reason: Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits. — Status: Ongoing
AG grant. $629,111. PI: Astrid M Suchy-Dicey
Sponsor: SPROUT PHARMS. Form: TABLET. Route: ORAL
Sponsor: WES PHARMA INC. Form: TABLET. Route: ORAL
Product code: OLZ. Advisory committee: Neurology. Type: Traditional
Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD Software Version: N/A Product Description: Digital Linear Accelerator Component: No — Reason: Due to a manufacturing issue and electrical grounding of systems. — Status: Ongoing
Sponsor: EISAI INC. Form: INJECTABLE. Route: INJECTION
Sponsor: EISAI INC. Form: INJECTABLE. Route: INJECTION
Sponsor: PHARMOBEDIENT. Form: SYRUP. Route: ORAL
Sponsor: AUROBINDO PHARMA. Form: TABLET. Route: ORAL
Sponsor: MACLEODS PHARMS LTD. Form: TABLET. Route: ORAL
Sponsor: ALKEM LABS LTD. Form: TABLET. Route: ORAL
Sponsor: AMNEAL PHARMS. Form: TABLET. Route: ORAL
Sponsor: SUN PHARM INDS LTD. Form: TABLET. Route: ORAL
Sponsor: ZYDUS PHARMS USA INC. Form: TABLET. Route: ORAL
Sponsor: SUN PHARM INDS INC. Form: TABLET. Route: ORAL
Sponsor: RISING. Form: TABLET. Route: ORAL
Sponsor: WATSON LABS. Form: TABLET. Route: ORAL
Sponsor: PRINSTON INC. Form: TABLET. Route: ORAL
Sponsor: SUN PHARM INDS INC. Form: TABLET. Route: ORAL
Sponsor: APOTEX. Form: TABLET. Route: ORAL
Sponsor: GE HEALTHCARE. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: GE HEALTHCARE. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: GE HEALTHCARE. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: GE HEALTHCARE. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: TORRENT. Form: CAPSULE
Sponsor: ASCENT PHARMS INC. Form: TABLET. Route: SUBLINGUAL
Sponsor: DAIICHI SANKYO. Form: INJECTABLE. Route: INJECTION
Sponsor: DAIICHI SANKYO. Form: INJECTABLE. Route: INJECTION
Sponsor: SANDOZ. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: NOVEL LABS INC. Form: TABLET. Route: ORAL
Sponsor: NOVEL LABS INC. Form: TABLET. Route: ORAL
Product code: OLO. Advisory committee: Neurology. Type: Traditional
Product code: NQQ. Advisory committee: Radiology. Type: Traditional
Product code: KRD. Advisory committee: Cardiovascular. Type: Special
Product code: KRO. Advisory committee: Orthopedic. Type: Traditional
Product code: NUC. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: LKF. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: OQB. Advisory committee: Orthopedic. Type: Traditional
Product code: NAY. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: QSY. Advisory committee: Unknown. Type: Traditional
Product code: DYB. Advisory committee: Cardiovascular. Type: Special
Product code: BZD. Advisory committee: Anesthesiology. Type: Traditional
Product code: OLI. Advisory committee: General, Plastic Surgery. Type: Traditional
Supplement type: Normal 180 Day Track. Product code: MVC. Advisory committee: PA. Decision: APPR
Supplement type: 30-Day Notice. Product code: NIK. Advisory committee: CV. Decision: OK30