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15,048 catalysts · 3,603 8k filing · 2,723 grant · 2,426 approval · 1,714 device 510k · 1,264 device recall · 1,172 device pma
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15,048 catalysts · 3,603 8k filing · 2,723 grant · 2,426 approval · 1,714 device 510k · 1,264 device recall · 1,172 device pma
Product code: QEX. Advisory committee: Cardiovascular. Type: Traditional
Product code: NUH. Advisory committee: Neurology. Type: Traditional
Product code: DSB. Advisory committee: Cardiovascular. Type: Traditional
Supplement type: Normal 180 Day Track. Product code: PRL. Advisory committee: CV. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: OTE. Advisory committee: RA. Decision: APPR
Supplement type: Normal 180 Day Track. Product code: ONU. Advisory committee: CV. Decision: APPR
Supplement type: Real-Time Process. Product code: PHP. Advisory committee: PA. Decision: APPR
Supplement type: Real-Time Process. Product code: OZG. Advisory committee: CV. Decision: APPR
BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener. — Reason: Removal of affected lot of screws due to labeling error. — Status: Ongoing
LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02 — Reason: For certain customers, the Change Summary review option ceases to operate as expected for any migrated library after the migration has been completed. Users must use alternate methods to review changes. Failure to do so may lead in over delivery, under delivery, or delay in setup on the infusion pump. — Status: Ongoing
Zimmer Air Dermatome, Model/Catalog Number: 00880100100 — Reason: The devices may have a misaligned thickness control bar. — Status: Ongoing
Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer. — Reason: A certain component of affected devices was not delivered within specification and contained impurities. — Status: Ongoing
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02 — Reason: Software issue only allows Concentration Limits to be defined to one digit of precision past the decimal point (0.1) instead of three digits (0.001). If the user is unable to use Concentration Limits as intended, they may need to change the limits to something other than what is recommended by the drug manufacturer, which may result in over- or under-delivery. — Status: Ongoing
FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeStyle Libre 3 sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System. — Reason: Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results — Status: Ongoing
Zimmer Dermatome AN, Model/Catalog Number: 88710100 — Reason: The devices may have a misaligned thickness control bar. — Status: Ongoing
FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System. — Reason: Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results — Status: Ongoing
Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 17188-04, 19762-03, 19203-04, 19203-04, 17957-10 Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A — Reason: Ophthalmic procedure packs may have incomplete seals affecting sterility. — Status: Ongoing
Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer. — Reason: A certain component of affected devices was not delivered within specification and contained impurities. — Status: Ongoing
FreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System. — Reason: Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results — Status: Ongoing
FreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code: 00357599819002 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System. — Reason: Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results — Status: Ongoing
Sponsor: AMNEAL PHARMS NY. Form: TABLET. Route: ORAL
Sponsor: ZYDUS PHARMS. Form: CAPSULE. Route: ORAL
Sponsor: LILLY. Form: INJECTABLE. Route: INJECTION
Sponsor: ABBVIE. Form: SUSPENSION/DROPS. Route: OPHTHALMIC
Sponsor: RILEY CONSUMER. Form: CAPSULE. Route: ORAL
Sponsor: SHENZHEN TECHDOW. Form: INJECTABLE. Route: SUBCUTANEOUS
Sponsor: MACLEODS PHARMS LTD. Form: TABLET. Route: ORAL
Sponsor: NOVARTIS. Form: TABLET. Route: ORAL
Sponsor: OTSUKA PHARM CO LTD. Form: INJECTABLE. Route: INJECTION
Sponsor: ASTRAZENECA UK LTD. Form: INJECTABLE. Route: INJECTION
Sponsor: HIBROW HLTHCARE. Form: TABLET. Route: ORAL
Sponsor: BAJAJ. Form: SOLUTION. Route: ORAL
Sponsor: TARO. Form: TABLET. Route: ORAL
Sponsor: ANTHEA PHARMA. Form: INJECTABLE. Route: INJECTION
Sponsor: MACLEODS PHARMS LTD. Form: TABLET. Route: ORAL
Sponsor: MSN. Form: TABLET. Route: ORAL
Product code: KNS. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: QKQ. Advisory committee: Pathology. Type: Traditional
Product code: OBR. Advisory committee: Unknown. Type: Traditional
Product code: PMC. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: QEW. Advisory committee: Cardiovascular. Type: Traditional
Product code: LRK. Advisory committee: Dental. Type: Abbreviated
Product code: HGX. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: KPS. Advisory committee: Radiology. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: OAS. Advisory committee: Radiology. Type: Traditional
Product code: QQI. Advisory committee: Cardiovascular. Type: Traditional
Product code: KTT. Advisory committee: Orthopedic. Type: Traditional
Product code: OHT. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: OMC. Advisory committee: Neurology. Type: Traditional