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18,617 catalysts · 4,728 grant · 3,655 8k filing · 2,622 approval · 2,141 device 510k · 1,730 device recall · 1,490 device pma
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18,617 catalysts · 4,728 grant · 3,655 8k filing · 2,622 approval · 2,141 device 510k · 1,730 device recall · 1,490 device pma
Sponsor: SOLARIS PHARMA CORP. Form: OINTMENT. Route: INTRA-ANAL
Sponsor: ASCENT PHARMS INC. Form: TABLET. Route: SUBLINGUAL
Sponsor: CHENGDU SHUODE. Form: INJECTABLE. Route: INJECTION
Sponsor: FORMYCON AG. Form: INJECTION
Sponsor: LUPIN LTD. Form: TABLET. Route: ORAL
Sponsor: MICRO LABS. Form: TABLET. Route: ORAL
Sponsor: CREEKWOOD PHARMS. Form: TABLET. Route: ORAL
Product code: DQK. Advisory committee: Cardiovascular. Type: Traditional
Product code: PKL. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: FDX. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: LIT. Advisory committee: Cardiovascular. Type: Traditional
Product code: KDI. Advisory committee: Gastroenterology, Urology. Type: Special
Product code: MXK. Advisory committee: Ophthalmic. Type: Traditional
Product code: QEW. Advisory committee: Cardiovascular. Type: Traditional
Product code: HIH. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: OLR. Advisory committee: Unknown. Type: Special
Product code: PND. Advisory committee: General Hospital. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: LRK. Advisory committee: Dental. Type: Traditional
Product code: QVA. Advisory committee: Radiology. Type: Traditional
Product code: MXD. Advisory committee: Cardiovascular. Type: Special
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: NHA. Advisory committee: Dental. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Supplement type: 30-Day Notice. Product code: PNF. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: MRM. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: LPC. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: MRM. Advisory committee: CV. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: OTL. Advisory committee: OP. Decision: APPR
Supplement type: 30-Day Notice. Product code: NBE. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NGV. Advisory committee: CV. Decision: OK30
Supplement type: Special (Immediate Track). Product code: MNB. Advisory committee: OB. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: MKJ. Advisory committee: CV. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: OZP. Advisory committee: CH. Decision: APPR
Supplement type: Normal 180 Day Track. Product code: DXY. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: MHY. Advisory committee: NE. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: MKJ. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: QES. Advisory committee: OR. Decision: OK30
Supplement type: 30-Day Notice. Product code: NBE. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NBE. Advisory committee: AN. Decision: OK30
Supplement type: 30-Day Notice. Product code: LGW. Advisory committee: NE. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: LMH. Advisory committee: SU. Decision: APPR
Supplement type: Real-Time Process. Product code: LGW. Advisory committee: NE. Decision: APPR
Supplement type: Normal 180 Day Track. Product code: LWS. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: OZG. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MFA. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: NJL. Advisory committee: OR. Decision: APPR
Supplement type: 30-Day Notice. Product code: MGB. Advisory committee: CV. Decision: OK30
Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784 UDI-DI code: 00827002607842 REF: TESLA-B2535-450 Model Number: G60785 UDI-DI code: 00827002607859 These devices are used for cannulation of the ductal system and for sphincterotomy. If preloaded, the device also aids in bridging difficult strictures during ERCP. It is indicated for sphincterotome-aided, wire-guided selective cannulation of the biliary ducts. — Reason: Due to product that may contain a void in the material that separates the wire guide and cutting wire lumens, which may cause an inappropriate path of current during cutting. — Status: Ongoing
Rifton Equipment, TRAM. Model/Catalog Number: K310. The TRAM is a powered lift device for transferring clients in a seated position or assisting in a sit-to-stand transfer and gait training. — Reason: Potential for fraying on the body support strap. — Status: Ongoing