calendar
12,103 catalysts · 3,603 8k filing · 2,280 grant · 1,746 approval · 1,120 device 510k · 1,000 device adverse event · 821 device pma
next 91 dayslessmore
MonWedFri
12,103 catalysts · 3,603 8k filing · 2,280 grant · 1,746 approval · 1,120 device 510k · 1,000 device adverse event · 821 device pma
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Product code: KWQ. Advisory committee: Orthopedic. Type: Traditional
Product code: FXX. Advisory committee: General, Plastic Surgery. Type: Traditional
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: LWR. Advisory committee: CV. Decision: OK30
Product code: NPU. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: MHY. Advisory committee: NE. Decision: OK30
Supplement type: 30-Day Notice. Product code: LMH. Advisory committee: SU. Decision: OK30
Supplement type: 30-Day Notice. Product code: LGW. Advisory committee: NE. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: PRL. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: LWL. Advisory committee: OP. Decision: OK30
Supplement type: 30-Day Notice. Product code: MKJ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LKK. Advisory committee: HO. Decision: OK30
Supplement type: 30-Day Notice. Product code: PHP. Advisory committee: MG. Decision: OK30
LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2519CP, medical procedure convenience kit — Reason: BD ChloraPrep Triple Swabsticks, a component within the kits, exhibit an open seal on the packaging of the applicators. — Status: Ongoing
Reprocessed Abbott Inquiry Steerable Diagnostic Catheters: Abbott Inquiry Steerable Diagnostic Catheter 10 Elec. 2-5-2mm 81105RH 81172RH; Abbott Inquiry Steerable Diagnostic Catheter 20 Elec. 2-10-2mm 81202RH; Abbott Inquiry Steerable Diagnostic Catheter 4 Elec. 5mm 81483RH; Inquiry Steerable Diagnostic Catheter 10 Elec. 2-5-2mm 81102RH 81104RH 81174RH 81531RH 81532RH; Inquiry Steerable Diagnostic Catheter 10 Elec. 5mm 81107RH; Inquiry Steerable Diagnostic Catheter 4 Elec. 2-5-2mm 81402RH 81404RH 81405RH 81474RH; Inquiry Steerable Diagnostic Catheter 4 Elec. 5mm 81473RH — Reason: These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025 — Status: Ongoing
Medline ReNewal Reprocessed Webster CS Catheters: Webster CS Catheter 10 Electrodes 2-8-2mm Spacing w/AutoID w/ EZ Steer BD710DF282CRH; Webster CS Catheter 10 Electrodes, 2-8-2mm Spacing w/ EZ Steer BD710DF282RRH BD710FJ282RRH; Webster CS Catheter 10 Electrodes, 2-8-2mm Spacing w/AutoID w/ EZ Steer BD710FJ282CRH; — Reason: These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025 — Status: Ongoing
Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters: ACUSON AcuNav Ultrasound Catheter, Use on GE Systems 10135910RH; 10043342RH ACUSON AcuNav Ultrasound Catheter, Use on Siemens Systems 10135936RH, 08255790RH — Reason: These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025 — Status: Ongoing
Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters: St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 2-5-2mm 401211RH 401222RH 401223RH 401226RH 401227RH 401260RH 401261RH 401306RH 401309RH 401312RH 401430RH 401433RH 401435RH 401441RH 401442RH 401443RH 401448RH 401449RH 401450RH 401451RH 401474RH 401860RH 401877RH 401878RH 401890RH 401891RH 401994RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 5-5-5mm 402012RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 5mm 402004RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 6 Elec. 2-5-2mm 402010RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 6 Elec. 5-5-5mm 402008RH 402009RH — Reason: These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025 — Status: Ongoing
Patient Information Center iX; Software Version Number: 4.5.0 — Reason: A recent software (SW) patch modifies Mobile Event Notification filter settings without providing any indication to the user when upgrading the system. — Status: Ongoing
Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters: Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on GE Systems 10439072RH; Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on Siemens Systems 10438577RH; Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter, Use on Siemens Systems 10439011RH — Reason: These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025 — Status: Ongoing
Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheters: Livewire Steerable Electrophysiology Catheter,10 Elec. 2-5-2mm 401582RH 401940RH; Livewire Steerable Electrophysiology Catheter,20 Elec. 2-10-2mm 401904RH; Livewire Steerable Electrophysiology Catheter,20 Elec. 2-5-2mm 401914RH; Livewire Steerable Electrophysiology Catheter,20 Elec. 2-8-2-60-2-8-2mm 401932RH; Livewire Steerable Electrophysiology Catheter,8 Elec. 2-2-2mm 401652RH; — Reason: These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025 — Status: Ongoing
Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters: ViewFlex Xtra ICE Catheter 9F x 90cm D087031RH 20197344019554¿ — Reason: These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025 — Status: Ongoing
DE grant. $698,865. PI: Lucia H Cevidanes
GM grant. $3,000. PI: Craig M Coopersmith
HL grant. $522,130. PI: Mete Civelek
AG grant. $49,438. PI: Jiachen Chen
Sponsor: STRIDES PHARMA. Form: TABLET. Route: ORAL
Sponsor: STRIDES PHARMA INTL. Form: TABLET. Route: ORAL
Sponsor: AMNEAL PHARMS. Form: TABLET. Route: ORAL
Sponsor: CIVICA. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: CHARTWELL. Form: TABLET. Route: ORAL
Sponsor: SUN PHARM INDS LTD. Form: TABLET. Route: ORAL
Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: SUBCUTANEOUS
Sponsor: ZYDUS PHARMS USA INC. Form: TABLET. Route: ORAL
Sponsor: ITERUM THERAP. Form: TABLET. Route: ORAL
Sponsor: ALKEM LABS LTD. Form: SOLUTION. Route: ORAL
Sponsor: SPECGX LLC. Form: TABLET. Route: ORAL
Sponsor: ELITE LABS INC. Form: TABLET. Route: ORAL
Sponsor: PHARM ASSOC. Form: SYRUP. Route: ORAL
Sponsor: JANSSEN PRODS. Form: POWDER. Route: INTRAVENOUS
Sponsor: SUN PHARM INDS INC. Form: TABLET. Route: ORAL
Sponsor: RUBICON RESEARCH. Form: TABLET. Route: ORAL
Sponsor: AGIOS PHARMS INC. Form: TABLET. Route: ORAL
Sponsor: CHENGDU SHUODE. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: BIOCRYST. Form: CAPSULE. Route: ORAL
Sponsor: MYLAN. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: ACTAVIS ELIZABETH. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: SUN PHARM INDS INC. Form: TABLET. Route: ORAL