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9,042 catalysts · 3,332 8k filing · 1,751 grant · 1,000 device adverse event · 820 approval · 632 device 510k · 584 earnings
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9,042 catalysts · 3,332 8k filing · 1,751 grant · 1,000 device adverse event · 820 approval · 632 device 510k · 584 earnings
Supplement type: 30-Day Notice. Product code: EZY. Advisory committee: GU. Decision: OK30
2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US. — Reason: A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bones taps having an incorrect thread. — Status: Ongoing
Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 3005PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the PKS electrical generator. — Reason: Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use. — Status: Ongoing
Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920000PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the PKS electrical generator. — Reason: Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use. — Status: Ongoing
Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Forceps Model/Catalog Number: PK-CF0533 Product Description: An assembly of devices intended to generate and apply radio-frequency (RF) alternating current to soft tissues for cutting and coagulation during an endoscopic or open surgical procedure. — Reason: Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use. — Status: Ongoing
Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 3005 Product Description: The OLYMPUS Everest Bipolar Cutting Forceps are intended to be passed through a 5 mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the bipolar outputs of compatible generators. — Reason: Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use. — Status: Ongoing
Brand Name: Olympus Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 3006 Product Description: The OLYMPUS Everest Bipolar Cutting Forceps are intended to be passed through a 5 mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the bipolar outputs of compatible generators. — Reason: Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use. — Status: Ongoing
Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920005PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the PKS electrical generator. — Reason: Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use. — Status: Ongoing
Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PKS Cutting Forceps Model/Catalog Number: HACF0533 Product Description: The HALO PKS Cutting Forceps are intended to be passed through a 5 mm laparoscopic cannula. Coagulation is achieved using electrosurgical energy under laparoscopic visualization. The device is intended to be used with the Gyrus ACMI G400 Workstation only. — Reason: Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use. — Status: Ongoing
2.4 VOLT(TM) TAP CORTEX SCREW TO 90MM. Part Number: 03.424.126-US. — Reason: A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bones taps having an incorrect thread. — Status: Ongoing
NR grant. $169,189. PI: Patricia Marie West
AI grant. $429,000. PI: Li Yen Loh
AI grant. $14,000. PI: TERRY L. SHEPPARD
AI grant. $15,500. PI: TERRY L. SHEPPARD
HD grant. $540,915. PI: Patricia Ann Homan
NS grant. $50,114. PI: Guadalupe Sanchez
Sponsor: MERZ PHARMS. Form: INJECTABLE. Route: INJECTION
Sponsor: ZYDUS LIFESCIENCES. Form: TABLET. Route: ORAL
Sponsor: BOEHRINGER INGELHEIM. Form: TABLET. Route: ORAL
Sponsor: ARGENX BV. Form: INJECTABLE. Route: INJECTION
Sponsor: ANTHEA PHARMA. Form: INJECTABLE. Route: INJECTION
Sponsor: SINOTHERAPEUTICS INC. Form: TABLET. Route: ORAL
Sponsor: TARO. Form: TABLET. Route: ORAL
Sponsor: TARO. Form: TABLET. Route: ORAL
Sponsor: BOEHRINGER INGELHEIM. Form: TABLET. Route: ORAL
Sponsor: GENSCO. Form: FILM. Route: ORAL
Sponsor: LONG GROVE PHARMS. Form: POWDER. Route: INTRAVENOUS
Sponsor: XCOVERY. Form: CAPSULE. Route: ORAL
Sponsor: BAXTER HLTHCARE CORP. Form: INJECTABLE. Route: INJECTION
Sponsor: ZYDUS LIFESCIENCES. Form: TABLET. Route: ORAL
Product code: HGM. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: KWQ. Advisory committee: Orthopedic. Type: Traditional
Product code: MAX. Advisory committee: Orthopedic. Type: Traditional
Product code: MBH. Advisory committee: Orthopedic. Type: Traditional
Product code: OWN. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: HIH. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: QAS. Advisory committee: Radiology. Type: Traditional
Product code: KCT. Advisory committee: General Hospital. Type: Traditional
Product code: FYA. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: OBR. Advisory committee: Unknown. Type: Traditional
Product code: OSN. Advisory committee: Orthopedic. Type: Traditional
Product code: QSY. Advisory committee: Unknown. Type: Traditional
Product code: FLE. Advisory committee: General Hospital. Type: Traditional
Supplement type: 30-Day Notice. Product code: NPT. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MCX. Advisory committee: CV. Decision: OK30
Supplement type: Real-Time Process. Product code: ONV. Advisory committee: SU. Decision: APPR
Supplement type: Real-Time Process. Product code: LKK. Advisory committee: HO. Decision: APPR
Supplement type: 30-Day Notice. Product code: LPM. Advisory committee: OP. Decision: OK30