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9,798 catalysts · 3,350 8k filing · 2,046 grant · 1,007 approval · 1,000 device adverse event · 732 device 510k · 584 earnings
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9,798 catalysts · 3,350 8k filing · 2,046 grant · 1,007 approval · 1,000 device adverse event · 732 device 510k · 584 earnings
Sponsor: HUMANWELL PURACAP. Form: CAPSULE. Route: ORAL
Sponsor: JANSSEN PRODS. Form: TABLET. Route: ORAL
Sponsor: ALMATICA. Form: CAPSULE, DELAYED REL PELLETS. Route: ORAL
Sponsor: ASTELLAS. Form: SOLUTION. Route: INTRAVITREAL
Sponsor: CELGENE CORP. Form: POWDER. Route: SUBCUTANEOUS
Sponsor: ASCENDIS. Form: POWDER. Route: SUBCUTANEOUS
Sponsor: CUBIST PHARMS LLC. Form: TABLET. Route: ORAL
Sponsor: NOVO NORDISK INC. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: NOVO NORDISK INC. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: NOVO NORDISK INC. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: CUBIST PHARMS LLC. Form: POWDER. Route: INTRAVENOUS
Sponsor: CAPLIN. Form: INJECTABLE. Route: INJECTION
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: CIG. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: MVL. Advisory committee: Unknown. Type: Traditional
Product code: DQA. Advisory committee: Cardiovascular. Type: Traditional
Product code: LFD. Advisory committee: Unknown. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: GCJ. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: MBI. Advisory committee: Orthopedic. Type: Traditional
Product code: ETN. Advisory committee: Ear, Nose, Throat. Type: Traditional
Product code: DXF. Advisory committee: Cardiovascular. Type: Special
Supplement type: Real-Time Process. Product code: NQR. Advisory committee: NE. Decision: APPR
Supplement type: 30-Day Notice. Product code: LGW. Advisory committee: NE. Decision: OK30
Supplement type: 30-Day Notice. Product code: QYI. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MGB. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: QON. Advisory committee: GU. Decision: OK30
Supplement type: Real-Time Process. Product code: NQR. Advisory committee: NE. Decision: APPR
Supplement type: 30-Day Notice. Product code: MTF. Advisory committee: IM. Decision: OK30
Supplement type: 30-Day Notice. Product code: QPT. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: QON. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: LTJ. Advisory committee: IM. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: MOM. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: EZW. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: MIH. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MIH. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NPV. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LMH. Advisory committee: SU. Decision: OK30
Supplement type: 30-Day Notice. Product code: EZW. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: QON. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: EZW. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: MHY. Advisory committee: NE. Decision: OK30
SIGNA Premier systems — Reason: Whole-Body MR scanners used to produce images of the inside of the human body to aid diagnosis of disease may have been manufactured/serviced with ferrous (steel) fittings instead of non-ferrous (brass) fittings on the magnet rear and if system is accessed to perform service while the magnet is ramped, the magnetic field could attract the ferrous fittings potentially resulting in personnel injury. — Status: Ongoing
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. NON VASCULAR PACK, Medline SKU # DYNJ68037C; 2. VEIN, Medline SKU # DYNJ89845; 3. VEIN, Medline SKU # DYNJ89845A. — Reason: Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold. — Status: Ongoing
NAMIC Angiographic Control Syringe, labeled as follows: 1. SYRINGE,7ML,TR/FR,RA,W/RES,-,P/G, Medline SKU 70083007; 2. SYRINGE,8ML,TR/FR,RA,W/RES,-,P/G, Medline SKU 70084007; 3. MTS,SYRINGE,8ML,TR/FR,RA,NO,RES,-,P/G, Medline SKU 70084017; 4. SYRINGE,7,ML,TR/FR,RA,W/RES,OEM,PG, Medline SKU 80083007; 5. SYRINGE,8,ML,TR/FR,RA,W/RES,OEM,PG, Medline SKU 80084007; 6. MTO,SYRINGE,8,ML,TR/FR,RA,NO,RES,OEM,PG, Medline SKU 80084017. — Reason: Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold. — Status: Ongoing
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. CATH LAB PACK-LF, Medline SKU 00-HCT055P; 2. INTERVENTIONAL CATH LAB PK-LF, Medline SKU DYNJ0376230Q; 3. ANGIOGRAPHY CATH LAB, Medline SKU DYNJ23532C; 4. ANGIO LEFT HEART PACK, Medline SKU DYNJ40632C; 5. ANGIO DRAPE PACK, Medline SKU DYNJ47952B; 6. ANGIOGRAPHIC PACK, Medline SKU DYNJ57516; 7. CATH LAB PACK, Medline SKU DYNJ58243B; 8. CATH LAB PACK, Medline SKU DYNJ65185; 9. CSU CATH MANIFOLD KIT, Medline SKU VASC1170A; 10. MANIFOLD KIT NO TRANSDUCER, Medline SKU VASC1184A. — Reason: Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold. — Status: Ongoing
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: CVOR ANGIOGRAPHY PACK-LF, Medline SKU DYNJ42367B — Reason: Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold. — Status: Ongoing
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: SPECIAL PROCEDURE TRAY, Medline SKU # DYNJ80513B — Reason: Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold. — Status: Ongoing