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14,268 catalysts · 3,350 8k filing · 2,402 grant · 2,350 approval · 1,681 device 510k · 1,204 device recall · 1,151 device pma
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14,268 catalysts · 3,350 8k filing · 2,402 grant · 2,350 approval · 1,681 device 510k · 1,204 device recall · 1,151 device pma
Product code: NKB. Advisory committee: Orthopedic. Type: Traditional
Product code: MOS. Advisory committee: Radiology. Type: Special
Product code: GCJ. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: NEW. Advisory committee: General, Plastic Surgery. Type: Traditional
Sevoflurane (SEVO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: 1. Sev E_Vap. (Safety Filling adapter), Part Number: 115-066756-00. 2. Exchange Sev E_Vap. (Safety Filling adapter), Part Number: E115-066756-00. Product Description: The Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The A9 Anesthesia System utilizes V90 electronic vaporizers for anesthetic agent delivery. — Reason: Potential for anesthesia leakage. — Status: Ongoing
Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03 — Reason: Medtronic personnel observed trace amounts of dry blood on the external carton label and Instructions for Use (IFU) in five boxes of one lot of ACT Cartridges. — Status: Ongoing
Isoflurane (ISO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: 1. Iso E_Vap. (Safety Filling adapter), Part Number 115-066758-00. 2. Exchange Iso E_Vap. (Safety Filling adapter), Part Number E115-066758-00. Product Description: The Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The A9 Anesthesia System utilizes V90 electronic vaporizers for anesthetic agent delivery. — Reason: Potential for anesthesia leakage. — Status: Ongoing
Sponsor: CSPC OUYI PHARM CO. Form: TABLET. Route: ORAL
Sponsor: SUN PHARM. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: LUPIN LTD. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: HIKMA. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: STRIDES PHARMA INTL. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: BOEHRINGER INGELHEIM PHARMACEUTICALS INC. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: PHARMACYCLICS LLC. Form: CAPSULE. Route: ORAL
Sponsor: AMGEN. Form: INJECTABLE. Route: INJECTION
Sponsor: PHARMACYCLICS LLC. Form: SUSPENSION. Route: ORAL
Sponsor: LUPIN LTD. Form: CAPSULE. Route: ORAL
Sponsor: PHARMOBEDIENT. Form: CAPSULE. Route: ORAL
Sponsor: PHARMOBEDIENT. Form: CAPSULE. Route: ORAL
Sponsor: AMNEAL. Form: INJECTABLE. Route: INJECTION
Sponsor: BAUSCH AND LOMB INC. Form: SOLUTION/DROPS. Route: OPHTHALMIC
Sponsor: PHARMACYCLICS LLC. Form: TABLET. Route: ORAL
Sponsor: PH HEALTH. Form: INJECTABLE. Route: SUBCUTANEOUS
Sponsor: FRESENIUS KABI USA. Form: SOLUTION. Route: INJECTION
Sponsor: ACTAVIS ELIZABETH. Form: TABLET, FOR SUSPENSION. Route: ORAL
Sponsor: ACTAVIS ELIZABETH. Form: TABLET, FOR SUSPENSION. Route: ORAL
Sponsor: ACTAVIS ELIZABETH. Form: TABLET, FOR SUSPENSION. Route: ORAL
Sponsor: ACTAVIS ELIZABETH. Form: TABLET, FOR SUSPENSION. Route: ORAL
Sponsor: ACTAVIS ELIZABETH. Form: TABLET, FOR SUSPENSION. Route: ORAL
Sponsor: ACTAVIS ELIZABETH. Form: TABLET, FOR SUSPENSION. Route: ORAL
Product code: FGE. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: KOI. Advisory committee: Anesthesiology. Type: Traditional
Product code: NKB. Advisory committee: Orthopedic. Type: Traditional
Product code: ONB. Advisory committee: General Hospital. Type: Special
Product code: HAW. Advisory committee: Neurology. Type: Traditional
Product code: NKB. Advisory committee: Orthopedic. Type: Special
Product code: DQK. Advisory committee: Cardiovascular. Type: Special
Product code: PBF. Advisory committee: Orthopedic. Type: Traditional
Product code: MBI. Advisory committee: Orthopedic. Type: Special
Product code: DYB. Advisory committee: Cardiovascular. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Supplement type: 30-Day Notice. Product code: NIM. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: QPT. Advisory committee: GU. Decision: OK30
Supplement type: Special (Immediate Track). Product code: NIO. Advisory committee: CV. Decision: APPR
Supplement type: Special (Immediate Track). Product code: NIP. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: MNQ. Advisory committee: AN. Decision: OK30
VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNow PRUTest is a whole blood test used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade. — Reason: Due to an device without a premarket clearance being incorrectly package and distributed. — Status: Ongoing
CareLink Clinic, REF: MMT-7350 — Reason: Software error causing incorrect data to be displayed on the 24-hour Sensor Glucose Overview Graph, any potential therapy decisions were made based on the incorrect data displayed on the 24-hour sensor glucose overview graph may lead to hypoglycemia or hyperglycemia. — Status: Ongoing
Sponsor: CENTOCOR ORTHO BIOTECH INC. Form: INJECTABLE. Route: INJECTION
Sponsor: CAPLIN. Form: INJECTABLE. Route: INTRAVENOUS