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13,742 catalysts · 3,431 8k filing · 2,401 grant · 2,188 approval · 1,517 device 510k · 1,123 device recall · 1,026 device pma
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13,742 catalysts · 3,431 8k filing · 2,401 grant · 2,188 approval · 1,517 device 510k · 1,123 device recall · 1,026 device pma
Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11.1 Product Description: Leksell GammaPlan¿ is a computer-based system designed for Leksell Gamma Knife¿ treatment planning. — Reason: Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference. This may result in a treatment plan that potentially irradiates the incorrect patient location if the error is not detected by users. — Status: Ongoing
Medline medical procedure convenience kits labeled as: 1) PACER / CATH LAB PACK-LF, Kit SKU DYNJ0972604A; 2) PACEMAKER/ICD PACK, Kit SKU DYNJ33822L; 3) VENOUS ACCESS PACK, Kit SKU DYNJ45640B; 4) PACEMAKER SET UP, Kit SKU DYNJ63377D; 5) PACK PACEMAKER CUSTOM,9909178, Kit SKU DYNJ65011D; 6) HEART BASIC OPEN PACK, Kit SKU DYNJ69143C; 7) SCC VEIN PACK, Kit SKU DYNJ69313; 8) CV PACK, Kit SKU DYNJ86007B. — 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
Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor. — Reason: It was found that the MX40 device could not reconnect to the PIC iX when moving between Radiohead and Trident 1.4 GHz access points if the signal strength changed quickly. — Status: Ongoing
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