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21,232 catalysts · 4,728 grant · 3,655 8k filing · 3,435 device 510k · 2,886 approval · 2,000 device pma · 2,000 device recall
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21,232 catalysts · 4,728 grant · 3,655 8k filing · 3,435 device 510k · 2,886 approval · 2,000 device pma · 2,000 device recall
Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Transducer Model/Catalog Number: SPL-T 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. Component: ShockPulse Lithotripsy System — Reason: The device may either fail to start up, or the transducer may start briefly and then stop, accompanied by an error light on the generator. In addition, the body of the transducer handpiece may gradually increase in temperature during clinical use. — Status: Ongoing
REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, IVD in conjunction with a Honeywell Vuquest or Jadk FM-5 barcode reader component. — Reason: Automated cell-locating device barcode reader may read the barcode of the previously processed slide resulting in a misattribution of diagnostic results. — Status: Ongoing
Brand Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Product Name: CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Model/Catalog Number: ACU10135910 Software Version: N/A Product Description: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Component: N/A — Reason: Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility or mechanical integrity of the device and can lead to severe adverse events such as infection, vascular injury or embolism. — Status: Ongoing
Brand Name: Sterilmed Reprocessed Imaging Catheter Product Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR USE WITH SIEMENS SYSTEM Model/Catalog Number: ACU10135936 Software Version: N/A Product Description: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR USE WITH SIEMENS SYSTEM Component: N/A — Reason: Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility or mechanical integrity of the device and can lead to severe adverse events such as infection, vascular injury or embolism. — Status: Ongoing
Sponsor: JANSSEN PHARMS. Form: SPRAY. Route: NASAL
Sponsor: UPSHER SMITH LABS. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL
Sponsor: ASCENT PHARMS INC. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: IMPAX LABS INC. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL
Sponsor: TEVA PHARMS USA. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL
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