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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
ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (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
Allura Xper FD10/10; Model Number: 722011; — 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 FD20/20; Model Number: 722038; — 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: LEASEIR Product Name: LEASEIR MHR XCELL Model/Catalog Number: MHR 110-b Software Version: 1.5.0.0 Product Description: The Leaseir MHR Xcell is a surgical laser instrument for use in general and plastic surgery and dermatology, intended for hair removal and treatment of pseudo folliculitis barbae on all skin types (Fitzpatrick I-VI). The process implies the generation of intense light pulses at specific wavelengths. The specific nature of the energies and pulse durations cause the desired effect (in the hair follicles and oxyhemoglobin in the blood) heating them sufficiently and destroying them without unnecessary damage to surrounding tissue. This is achieved by controlled emission of laser radiation to the target tissue. The system consists of a main console and two interchangeable applicators that delivers pulsed light in the range of 800-820nm with a peak in the 810nm in different spot sizes. Two of the applicators emitting radiation at 810 nm wavelength for two areas 13.5¿15 mm¿ and 14.5¿25.5 mm¿. Two different operation modes are available: static mode and dynamic mode, which are differentiated basically by the frequency range defined for each mode (1-4 Hz for static and 10 Hz for dynamic). The principle of operation consists in the photons travel along the axis and reflected again back into the crystal, continuing the chain reaction, while photons travelling in different directions leave the crystal. In one of the two mirrors, a tiny hole allows a small amount of light to leak out and the resulting beam is focused with lenses and is emitted from the laser. The total energy emitted by the Leaseir MHR Xcell is produced by an array of diodes. The laser emission is activated by the hand piece trigger, deliver a continuous pulse pattern while the button is pressed. Component: NO — Reason: The console label for affected devices is missing the "DANGER" symbol. — Status: Ongoing
Allura Xper FD10/10; Model Number: 722005; — 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: 722012; — 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
Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intended for the qualitative detection in plasma or serum of the anti-heparin-platelet factor 4 (PF4) antibodies generated during the type II heparin-induced thrombocytopenia (HIT type II) by ELISA. — Reason: Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results. — Status: Ongoing
Allura Xper FD20/10; Model Number: 722029; — 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 Precision IV Pump, List Numbers: 400020403 (US), 400021003 (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
Brand Name: Broselow Product Name: Broselow Domestic Complete ALS Organizer Model/Catalog Number: 7730ALS 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; Model Number: 722010; — 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
TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number BN168792, running software versions 00-17 — Reason: Under specific conditions, the lift's electromagnetic holding force may disengage unexpectedly, allowing unintended downward movement of the lift. — Status: Ongoing
Allura Xper FD20 Biplane; Model Number: 722008; — 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" FILLED BROSELOW ORGANIZER Model/Catalog Number: 7730IALS 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
Plum Duo Infusion System, List Number 40002-04-01 — Reason: ICU Medical received one lot of defective primary speakers from our supplier that may fail to produce an audible sound. If the primary speaker in your Plum Duo Infusion Pump fails, the pump may not produce audible alarms, alerts, or provide audible feedback for touchscreen inputs. — Status: Ongoing
Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700REA 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
Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument. — Reason: Presence of particulates in affected devices that can be deposited into breast tissue during use. — Status: Ongoing
Allura Xper FD20 OR Table; Model Number: 722023; — 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 Biplane; Model Number: 722013; — 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: Nasal Jejunal Feeding Tube REF: NJFT-10 — Reason: Nasal feeding tube packaged without the nasal transfer tube component. — Status: Ongoing
Allura Xper FD10; Model Number: 722026; — 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: 722006; — 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
AG grant. $716,579. PI: Erik Bradley Bloss
DC grant. $41,394. PI: Bao Le
AG grant. $639,838. PI: MARC D TAMBINI
AG grant. $659,309. PI: Tatiana V Byzova
AG grant. $429,394. PI: Shawn Brady Bender
Sponsor: APOTEX INC. Form: CAPSULE. Route: ORAL
Sponsor: PFIZER INC. Form: INJECTABLE. Route: SUBCUTANEOUS
Sponsor: GLAXOSMITHKLINE LLC. Form: INJECTION
Sponsor: NOVITIUM PHARMA. Form: SYRUP. Route: ORAL
Sponsor: AUROBINDO PHARMA LTD. Form: SPRAY, METERED. Route: NASAL
Sponsor: ALEMBIC PHARMS LTD. Form: TABLET. Route: ORAL
Sponsor: AUROBINDO PHARMA LTD. Form: CAPSULE. Route: ORAL
Sponsor: IBSA. Form: FILM. Route: ORAL
Sponsor: HETERO LABS LTD V. Form: TABLET. Route: ORAL
Sponsor: AMNEAL IRELAND LTD. Form: AEROSOL, METERED. Route: INHALATION
Sponsor: ALEMBIC PHARMS LTD. Form: TABLET. Route: ORAL
Product code: OVK. Advisory committee: Immunology. Type: Traditional
Product code: FDS. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: DXQ. Advisory committee: Cardiovascular. Type: Traditional
Product code: LJS. Advisory committee: General Hospital. Type: Traditional
Product code: SCV. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: FGB. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: GAM. Advisory committee: General, Plastic Surgery. Type: Special
Product code: FGB. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: HSX. Advisory committee: Orthopedic. Type: Traditional
Product code: OWB. Advisory committee: Radiology. Type: Traditional
Product code: PPW. Advisory committee: Cardiovascular. Type: Traditional