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20,598 catalysts · 4,728 grant · 3,674 8k filing · 3,025 device 510k · 2,768 approval · 2,000 device pma · 2,000 device recall
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20,598 catalysts · 4,728 grant · 3,674 8k filing · 3,025 device 510k · 2,768 approval · 2,000 device pma · 2,000 device recall
FORCEP, STD STR, STERILE KELLY, 5.5 IN, Item Number DYNJ04048 — Reason: The items may have weak packaging seals that may result in a breach of sterility if the seal fails and may lead to an increased risk of infection if product is utilized. — Status: Ongoing
Sponsor: AZURITY. Form: TABLET. Route: ORAL
Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION
Sponsor: PFIZER. Form: TABLET. Route: ORAL
Sponsor: ABBVIE ENDOCRINE INC. Form: POWDER. Route: INTRAMUSCULAR
Sponsor: TEVA PHARMS USA. Form: TABLET. Route: ORAL
Sponsor: TEVA PHARMS USA. Form: TABLET. Route: ORAL
Sponsor: TEVA PHARMS USA. Form: TABLET. Route: ORAL
Sponsor: TEVA PHARMS USA. Form: TABLET. Route: ORAL
Sponsor: TEVA PHARMS USA. Form: TABLET. Route: ORAL
Sponsor: TEVA PHARMS USA. Form: TABLET. Route: ORAL
Sponsor: TEVA PHARMS USA. Form: TABLET. Route: ORAL
Sponsor: TEVA PHARMS USA. Form: TABLET. Route: ORAL
Sponsor: TEVA PHARMS USA. Form: TABLET. Route: ORAL
Sponsor: TEVA PHARMS USA. Form: TABLET. Route: ORAL
Sponsor: TEVA PHARMS USA. Form: TABLET. Route: ORAL
Sponsor: TEVA PHARMS USA. Form: TABLET. Route: ORAL
Sponsor: NAVINTA LLC. Form: GEL. Route: RECTAL
Sponsor: ACCORD HLTHCARE. Form: CAPSULE. Route: ORAL
Sponsor: AVET LIFESCIENCES. Form: INJECTABLE. Route: INJECTION
Sponsor: TEVA PHARMS USA. Form: TABLET. Route: ORAL
Sponsor: TEVA PHARMS USA. Form: TABLET. Route: ORAL
Sponsor: TEVA PHARMS USA. Form: TABLET. Route: ORAL
Sponsor: TEVA PHARMS USA. Form: TABLET. Route: ORAL
Sponsor: TEVA PHARMS USA. Form: TABLET. Route: ORAL
Sponsor: TEVA PHARMS USA. Form: TABLET. Route: ORAL
Sponsor: AUROBINDO PHARMA LTD. Form: FOR SOLUTION. Route: ORAL
Sponsor: PFIZER. Form: TABLET. Route: ORAL
Sponsor: ALEMBIC. Form: TABLET. Route: ORAL
Sponsor: ASCENT PHARMS INC. Form: TABLET. Route: ORAL
Sponsor: HAINAN POLY PHARM. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: APOTEX. Form: TABLET. Route: ORAL
Sponsor: ASTRAZENECA. Form: TABLET. Route: ORAL
Product code: SCA. Advisory committee: Microbiology. Type: Dual Track
Product code: KCT. Advisory committee: General Hospital. Type: Traditional
Product code: HQC. Advisory committee: Ophthalmic. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: FIP. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: SDO. Advisory committee: Physical Medicine. Type: Traditional
Product code: CAF. Advisory committee: Anesthesiology. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: FRF. Advisory committee: General Hospital. Type: Traditional
Product code: SGN. Advisory committee: Neurology. Type: Direct
Product code: MYN. Advisory committee: Radiology. Type: Traditional
Product code: LSR. Advisory committee: Microbiology. Type: Traditional
Product code: OHT. Advisory committee: General, Plastic Surgery. Type: Traditional
Supplement type: Real-Time Process. Product code: OCM. Advisory committee: CV. Decision: APPR
Supplement type: Normal 180 Day Track. Product code: MTA. Advisory committee: OP. Decision: APPR
Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy System - Generator Model/Catalog Number: SPL-G Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse transducer is a reusable device that requires cleaning and steam sterilization prior to use in order to generate both low-frequency mechanical impacts and high-frequency ultrasonic energy that quickly disintegrates stones. — Reason: Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues. — Status: Ongoing
Halyard, MIDTOWN GENERAL ARTERIOGRAM. Catalog Number: EUHM009-01. — Reason: Potential for incomplete seal on header bag. — Status: Ongoing