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23,643 catalysts · 4,889 device 510k · 4,728 grant · 3,704 8k filing · 3,531 approval · 2,000 device pma · 2,000 device recall
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23,643 catalysts · 4,889 device 510k · 4,728 grant · 3,704 8k filing · 3,531 approval · 2,000 device pma · 2,000 device recall
MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195028 MS-00009 (Pack of 10) - MOLLI Introducer (12cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195134 MP2001 - MOLLI 2 Wand UDI (GTIN): 00850024195141 MP2015A - MOLLI OncoPen UDI (GTIN): 00850024195219 MT2001 - MOLLI 2 Tablet UDI (GTIN): 00850024195158 The MOLLI Marker is intended to be placed percutaneously in soft tissue to temporarily mark a surgical site intended for surgical removal. the MOLLI Marker is located and surgically removed with the target tissue. — Reason: Due to a need to update the product labeling (Instructions for Use IFU) as a result of the magnetized surgical tools dislodging markers using during target tissue removal procedures. — Status: Ongoing
Adapt Pump, Model/Catalog Number: 61600200-Adapt Pump, component of Adapt support surfaces (Adapt Air, Adapt Air EX, Adapt Air Pro, Adapt Air Pro EX, Adapt Convertible, Adapt Convertible EX), sofware version 1.3.0; Mattress, Air Flotation, Alternating Pressure — Reason: Agiliti identified an issue where the Adapt Pump (61600200-Adapt Pump) supplied with all Adapt Line support surfaces does not re-engage the Microclimate Management function after using the Autofirm function for 10 minutes. This issue only occurs when the 10-minute timer is allowed to elapse after the Autofirm button is pressed after initial setup, and it only affects the Microclimate Management function. — Status: Ongoing
HL grant. $18,100. PI: TERRY L. SHEPPARD
Sponsor: SCIEGEN PHARMS. Form: TABLET. Route: ORAL
Sponsor: APOTEX. Form: SOLUTION/DROPS. Route: OPHTHALMIC
Sponsor: CADILA PHARMS LTD. Form: TABLET. Route: ORAL
Sponsor: WATSON LABS. Form: TABLET. Route: ORAL
Sponsor: SUN PHARM. Form: CAPSULE. Route: ORAL
Sponsor: SUN PHARM. Form: CAPSULE. Route: ORAL
Sponsor: APOTEX. Form: CAPSULE. Route: ORAL
Sponsor: TEVA PHARMS INC. Form: TABLET. Route: ORAL
Sponsor: VISTAPHARM LLC. Form: SOLUTION. Route: ORAL
Sponsor: UPSHER SMITH LABS. Form: CAPSULE. Route: ORAL
Sponsor: UCB INC. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: CHARTWELL RX. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: CHARTWELL RX. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: EPIC PHARMA LLC. Form: TABLET. Route: ORAL
Product code: NHA. Advisory committee: Dental. Type: Traditional
Product code: PHX. Advisory committee: Orthopedic. Type: Traditional
Product code: FLE. Advisory committee: General Hospital. Type: Traditional
Product code: DYB. Advisory committee: Cardiovascular. Type: Traditional
Product code: KGN. Advisory committee: Unknown. Type: Traditional
Product code: HGX. Advisory committee: Obstetrics/Gynecology. Type: Special
Product code: PML. Advisory committee: Orthopedic. Type: Traditional
Product code: DRG. Advisory committee: Cardiovascular. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: PPU. Advisory committee: Microbiology. Type: Traditional
Product code: NHA. Advisory committee: Dental. Type: Traditional
Supplement type: 30-Day Notice. Product code: SGV. Advisory committee: SU. Decision: OK30
Supplement type: 30-Day Notice. Product code: LGW. Advisory committee: NE. Decision: OK30
Supplement type: 30-Day Notice. Product code: NHL. Advisory committee: NE. Decision: OK30
Supplement type: 135 Review Track For 30-Day Notice. Product code: QWM. Advisory committee: CV. Decision: APPR
Sponsor: JANSSEN PHARMS. Form: SPRAY. Route: NASAL
Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTION. Route: SOLUTION
Sponsor: CUMBERLAND PHARMS. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: OMNIVIUM PHARMS. Form: POWDER. Route: INTRAMUSCULAR
Sponsor: LUPIN. Form: TABLET. Route: ORAL
Sponsor: LUPIN. Form: TABLET. Route: ORAL
Sponsor: MANNKIND. Form: POWDER. Route: INHALATION
Sponsor: VERTEX PHARMS INC. Form: TABLET. Route: ORAL
Product code: GCJ. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: DJG. Advisory committee: Clinical Toxicology. Type: Traditional
Product code: OLO. Advisory committee: Neurology. Type: Traditional
Product code: NEU. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: DSI. Advisory committee: Cardiovascular. Type: Traditional
Product code: LZA. Advisory committee: General Hospital. Type: Traditional
Product code: QKB. Advisory committee: Radiology. Type: Traditional
Product code: FRO. Advisory committee: Unknown. Type: Traditional
Product code: MAX. Advisory committee: Orthopedic. Type: Traditional