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14,206 catalysts · 3,288 8k filing · 2,402 grant · 2,350 approval · 1,681 device 510k · 1,204 device recall · 1,151 device pma
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14,206 catalysts · 3,288 8k filing · 2,402 grant · 2,350 approval · 1,681 device 510k · 1,204 device recall · 1,151 device pma
Sponsor: ANDA REPOSITORY. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL
Sponsor: REGENERON PHARMACEUTICALS. Form: INJECTABLE. Route: INJECTION
Sponsor: EXELIXIS INC. Form: TABLET. Route: ORAL
Sponsor: HIKMA. Form: TABLET. Route: ORAL
Sponsor: EXELIXIS. Form: CAPSULE. Route: ORAL
Sponsor: SANDOZ. Form: SOLUTION/DROPS. Route: OPHTHALMIC
Sponsor: PFIZER INC. Form: INJECTABLE. Route: INJECTION
Sponsor: GRANULES. Form: TABLET. Route: ORAL
Sponsor: RELIANCE LIFE. Form: POWDER. Route: INTRAVENOUS
Sponsor: GLAND. Form: POWDER. Route: INTRAMUSCULAR
Sponsor: AZURITY. Form: INJECTABLE. Route: INJECTION
Sponsor: SUN PHARMA CANADA. Form: SOLUTION. Route: ORAL
Product code: MRC. Advisory committee: Ophthalmic. Type: Traditional
Product code: NXC. Advisory committee: Dental. Type: Special
Product code: NFO. Advisory committee: Neurology. Type: Traditional
Product code: NFT. Advisory committee: Clinical Toxicology. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: DXN. Advisory committee: Cardiovascular. Type: Special
Product code: ODC. Advisory committee: Gastroenterology, Urology. Type: Special
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: OLT. Advisory committee: Neurology. Type: Traditional
Product code: MQB. Advisory committee: Radiology. Type: Special
Product code: FER. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Special
Product code: HEB. Advisory committee: Obstetrics/Gynecology. Type: Special
Product code: FIP. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: OUR. Advisory committee: Orthopedic. Type: Special
Supplement type: Normal 180 Day Track No User Fee. Product code: OZP. Advisory committee: CH. Decision: APPR
Supplement type: 30-Day Notice. Product code: LMG. Advisory committee: SU. Decision: OK30
Supplement type: 30-Day Notice. Product code: MCN. Advisory committee: OB. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: QWM. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: NVN. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: DSQ. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: SFI. Advisory committee: CH. Decision: APPR
Supplement type: Normal 180 Day Track. Product code: QES. Advisory committee: OR. Decision: APPR
Supplement type: Panel Track. Product code: HQL. Advisory committee: OP. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: MDS. Advisory committee: CH. Decision: APPR
Supplement type: 30-Day Notice. Product code: MIH. Advisory committee: CV. Decision: OK30
Myosa for Kids KS1 REF MyOSAKS1_Sb/Sp/Mb/Mp/Lb/Lc KS2 REF MyOSAKS2_Sb/Sc/Mb/Mc/Mp/Lb/Lc Myosa for Kids is a mouthguard in 3 different sizes (sm, med, lg) that can be used in children ages 3-15 to address breathing and myofunctional disorders. Catalog Numbers: — Reason: Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval. — Status: Ongoing
Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Model/Catalog Number: 106531US, HeartMate 3 Controller, US; 106531INT, HeartMate 3 Controller, OUS; 106531LF2, HeartMate 3 Low Flow 2.0 Controller Software Version: N/A Product Description: The HeartMate 3" System Controller acts as the central power and communication hub for the HeartMate 3 LVAS. It passes power from the Power Module, the Mobile Power Unit, Lithium-Ion Batteries, or its own integrated emergency backup supply, down to the LVAD via the Driveline. The HeartMate 3 System Controller constantly monitors system performance through communication with the implanted LVAD and Controller internal measurements and alerts the user to any alarm conditions by activating membrane panel LEDs and integrated audio annunciators. Further information on alarm conditions as well as system status can be attained by the user from the front panel LCD on the System Controller. When connected to a HeartMate Touch" Communication System, the System Controller sends information regarding the System Controller and Pump Status once per second to provide additional information to the user. This link also allows the clinician to set new patient operating parameters (e.g. pump speed) and provides a link for downloading trend and/or event recorder data. Component: Yes, HeartMate 3 LVAS — Reason: Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm. — Status: Ongoing
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic — Reason: GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions. — Status: Ongoing
bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic — Reason: GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions. — Status: Ongoing
UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic — Reason: GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions. — Status: Ongoing
Brand Name: HeartMate Product Name: HeartMate II¿ Controller (standalone) Model/Catalog Number: 106017, HeartMate II¿ Pocket Controller, US; 106762, HeartMate II¿ Pocket Controller, US; 107801, HeartMate II¿ Pocket Controller Software Version: N/A Product Description: The HeartMate II System Controller is a small computer that controls and monitors system operation. It sends power and operating signals to the Left Ventricular Assist Device and adjusts device operation to maintain programmed levels of cardiac support. The System Controller identifies alarm conditions and initiates Hazard and Advisory alarms. It records device performance and alarm data, and transfers the information to the HeartMate Touch Communication System. Component: Yes, HeartMate II¿ LVAS Implant Kit — Reason: Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm. — Status: Ongoing
SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE — Reason: The impacted lot may not meet the required tensile strength specification. — Status: Ongoing
Brand Name: HeartMate Product Name: HeartMate II¿ LVAS Implant Kit Model/Catalog Number: 106015, HeartMate II¿ LVAS Kit, with Pocket Controller, Sealed, US; 106016, HeartMate II¿ LVAS Kit, with Pocket Controller, Sealed, EU Software Version: N/A Product Description: The HeartMate II LVAS is an axial-flow, rotary ventricular assist system that generates flows up to 10 liters per minute (lpm). One end of the Left Ventricular Assist Device is attached to the apex of the left ventricle; the other end of the device connects to the ascending aorta. The Left Ventricular Assist Device diverts blood from the weakened left ventricle and propels it to the aorta. A small external computer, the System Controller, monitors system operation. A driveline, which passes through the patient s abdomen, connects the implanted pump to the System Controller. The system is powered by a Power Module or Mobile Power Unit (MPU) that is connected to an AC electrical outlet, or by two HeartMate 14 Volt Lithium-Ion batteries. Component: No — Reason: Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm. — Status: Ongoing
Quantum Intersegmental Table, Model/Catalog Number: Q400; heated massage table — Reason: The heat function may become damaged over time due to patients pressing on the areas with heat function components. Damage to components can lead to overheating which can lead to smoldering and melting of the vinyl cushion. — Status: Ongoing
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic — Reason: GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions. — Status: Ongoing
bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic — Reason: GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions. — Status: Ongoing
SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE — Reason: The impacted lot may not meet the required tensile strength specification. — Status: Ongoing