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15,048 catalysts · 3,603 8k filing · 2,723 grant · 2,426 approval · 1,714 device 510k · 1,264 device recall · 1,172 device pma
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15,048 catalysts · 3,603 8k filing · 2,723 grant · 2,426 approval · 1,714 device 510k · 1,264 device recall · 1,172 device pma
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L4C 5H2, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-1003-1. — Reason: Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns — Status: Ongoing
Carbamazepine Extended-Release Tablets, USP 400 mg, 30 Tablets per carton (3x10 unit dose cards), Rx Only, American Health Packaging, Columbus, OH 43217. Carton NDC 60687-594-21; (Individual Dose NDC: 60687-594-11) — Reason: Failed Dissolution Specifications. — Status: Ongoing
Product code: SET. Advisory committee: Immunology. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: FOZ. Advisory committee: General Hospital. Type: Traditional
Product code: HWC. Advisory committee: Orthopedic. Type: Traditional
Product code: KTI. Advisory committee: Ear, Nose, Throat. Type: Special
Product code: DYB. Advisory committee: Cardiovascular. Type: Special
Product code: LFL. Advisory committee: Unknown. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: HDB. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: OAS. Advisory committee: Radiology. Type: Traditional
Supplement type: 30-Day Notice. Product code: NVZ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWP. Advisory committee: CV. Decision: OK30
Supplement type: Real-Time Process. Product code: PZK. Advisory committee: OP. Decision: APPR
Supplement type: 30-Day Notice. Product code: QZI. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: SDA. Advisory committee: AN. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: LEI. Advisory committee: GU. Decision: APPR
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