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11,937 catalysts · 3,350 8k filing · 2,283 grant · 1,767 approval · 1,155 device 510k · 1,000 device adverse event · 833 device pma
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11,937 catalysts · 3,350 8k filing · 2,283 grant · 1,767 approval · 1,155 device 510k · 1,000 device adverse event · 833 device pma
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
Supplement type: 30-Day Notice. Product code: SEG. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NJL. Advisory committee: OR. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: NGV. Advisory committee: CV. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: QXB. Advisory committee: GU. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: NGV. Advisory committee: CV. Decision: APPR
Product code: SGV. Advisory committee: SU. Decision: APPR
Supplement type: Normal 180 Day Track. Product code: NYQ. Advisory committee: PA. Decision: APPR
Supplement type: Normal 180 Day Track. Product code: SDK. Advisory committee: GU. Decision: APPR
Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: ONV. Advisory committee: SU. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MAQ. Advisory committee: MI. Decision: OK30
Estrone RIA, REF: DSL8700 — Reason: The affected Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary injury of Remote probability. Only in some (very rare) cases may the issue occur. — Status: Ongoing
da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,Box) — Reason: Access Port System tray may develop cracks potentially resulting in a sterility breach. — Status: Ongoing
Allura Xper FD10F; Model Number: 722002; — Reason: Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown. — Status: Ongoing
Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700RE Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care. Component: No — Reason: Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. — Status: Ongoing
Allura Xper FD10/10; Model Number: 722027; — Reason: Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown. — Status: Ongoing
Allura Xper FD20; Model Number: 722028; — Reason: Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown. — Status: Ongoing
Product Name: Allura Xper FD10C; Model number: 722001; — Reason: Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown. — Status: Ongoing
Allura Xper FD10; Model Number: 722003; — Reason: Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown. — Status: Ongoing
ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines) — Reason: Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed. — Status: Ongoing