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19,656 catalysts · 4,728 grant · 3,203 8k filing · 2,737 device 510k · 2,721 approval · 2,000 device recall · 1,916 device pma
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19,656 catalysts · 4,728 grant · 3,203 8k filing · 2,737 device 510k · 2,721 approval · 2,000 device recall · 1,916 device pma
Supplement type: 30-Day Notice. Product code: MHY. Advisory committee: NE. Decision: OK30
Supplement type: 30-Day Notice. Product code: LKK. Advisory committee: HO. Decision: OK30
Supplement type: 30-Day Notice. Product code: LKK. Advisory committee: HO. Decision: OK30
SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A — Reason: Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel with antimicrobial coating, or 3)Natural latex with infection control, when it's silicone hydrogel coated without antimicrobial coating, which may cause infection and/or local and/or systemic allergic reaction — Status: Ongoing
SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303414A — Reason: Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel with antimicrobial coating, or 3)Natural latex with infection control, when it's silicone hydrogel coated without antimicrobial coating, which may cause infection and/or local and/or systemic allergic reaction — Status: Ongoing
Brand Name: ReQuest Measles IgM Product Name: Enzyme Linked Immunoabsorbant Assay, Rubeola IgM Model/Catalog Number: 01-190M Software Version: N/A Product Description: Measles IgM tests, performed using ELISA (Enzyme-Linked Immunosorbent Assay) method, used to detect the presence of IgM antibodies against measles virus in a patient's serum or plasma Component: not a component — Reason: Measles IgM Test Kit lacks premarket approval or clearance. — Status: Ongoing
IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. The IPC POWEREASE System is indicated for drilling, tapping, and driving screws and working end attachments during spinal surgery, including open and minimally invasive procedures. The IPC POWEREASE System is also used in the placement of screws, or cutting of screws, posts, and rods. The IPC is indicated for the incision/cutting, removal, drilling, and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Cranial, Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures. — Reason: Due to out of the box wobble of the driver. — Status: Ongoing
SureStep Foley Tray System BARD¿ Lubri-Sil Foley Catheter Tray, REF: A942216 — Reason: Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel with antimicrobial coating, or 3)Natural latex with infection control, when it's silicone hydrogel coated without antimicrobial coating, which may cause infection and/or local and/or systemic allergic reaction — Status: Ongoing
Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029 — Reason: Surgical drape packs may have open seals, which may compromise the sterility of the product. — Status: Ongoing
Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software — Reason: Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) , — Status: Ongoing
Product code: JFT. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: MQV. Advisory committee: Orthopedic. Type: Traditional
Product code: MOS. Advisory committee: Radiology. Type: Abbreviated
Product code: DQO. Advisory committee: Cardiovascular. Type: Traditional
Product code: MUD. Advisory committee: Cardiovascular. Type: Traditional
Product code: JXI. Advisory committee: Neurology. Type: Traditional
Product code: MAX. Advisory committee: Orthopedic. Type: Traditional
Product code: EIA. Advisory committee: Dental. Type: Special
Product code: MOF. Advisory committee: Cardiovascular. Type: Traditional
Product code: LNH. Advisory committee: Radiology. Type: Traditional
Product code: KPS. Advisory committee: Radiology. Type: Traditional
Product code: MUE. Advisory committee: Radiology. Type: Traditional
Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL
Supplement type: Real-Time Process. Product code: PHP. Advisory committee: PA. Decision: APPR
Supplement type: Real-Time Process. Product code: PHP. Advisory committee: PA. Decision: APPR
Supplement type: Real-Time Process. Product code: DSQ. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: LMF. Advisory committee: SU. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: SEQ. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: QQK. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: HQL. Advisory committee: OP. Decision: OK30
Supplement type: 135 Review Track For 30-Day Notice. Product code: NJL. Advisory committee: OR. Decision: APPR
Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER BOSS DRILL, 6.5mm Model/Catalog Number: 804-06-312 Product Description: Material: S.S., Non Sterile — Reason: Their is a potential that the reamer may kick or bind up during or immediately prior to use. — Status: Ongoing
Brand Name: DJO SURGICAL Product Name: FA S Altivate Reverse Glenoid Tray Model/Catalog Number: None Software Version: NA Product Description: Enovis" shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for use. While total shoulder replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients. The AltiVate Reverse¿ Shoulder Prosthesis is indicated as a reverse shoulder replacement for patients with a functional deltoid muscle and a grossly deficient rotator cuff joint suffering from pain and dysfunction due to: " Severe arthropathy with a grossly deficient rotator cuff; " Previously failed joint replacement with a grossly deficient rotator cuff; " Fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder including humeral head fracture, displaced 3- or 4-part fractures of proximal humerus, or reconstruction after tumor resection; " Bone defect in proximal humerus; " Non-inflammatory degenerative disease including osteoarthritis and avascular necrosis of the natural humeral head and/or glenoid; " Inflammatory arthritis including rheumatoid arthritis; " Correction of functional deformity. The glenoid baseplate is intended for cementless application with addition of screws for fixation. This device may also be indicated in the salvage of previously failed surgical attempts for anatomic and hemi procedures. All RSP¿ Monoblock and AltiVate Reverse¿ humeral stems are intended for cemented or cementless use. Enovis" instrumentation consists of devices and their accessories used in surgical procedures. Implantation of Enovis" products should only be performed with Enovis" instrumentation or instrumentation distributed by Enovis". Enovis" instruments and instrument cases are generally composed of titanium, stainless steel, aluminum, and/or polymeric materials. The cases may be multi-layered with various inserts to hold surgical instrumentation in place during handling and storage. The inserts may consist of trays, holders, and silicone mats. The instrument cases will allow sterilization of the contents to occur in a steam autoclave utilizing the cleaning, sterilization, and drying cycle that has been validated and detailed below. Instrument cases do not provide a sterile barrier and must be used in conjunction with FDA cleared sterilization wrap to maintain sterility. Instruments are provided non-sterile and should be stored in their original packaging until cleaned and sterilized according to the recommended guidelines listed below. Component: NA — Reason: Their is a potential that the reamer may kick or bind up during or immediately prior to use. — Status: Ongoing
Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER HEAD Model/Catalog Number: 804-06-311 Product Description: Material: S.S/Nitronic, Non-Sterile — Reason: Their is a potential that the reamer may kick or bind up during or immediately prior to use. — Status: Ongoing
Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER SLEEVE Model/Catalog Number: 804-06-310 Product Description: Material: S.S/CoCrMo, Non-Sterile — Reason: Their is a potential that the reamer may kick or bind up during or immediately prior to use. — Status: Ongoing
Product code: LZO. Advisory committee: Orthopedic. Type: Special
Product code: PJA. Advisory committee: Cardiovascular. Type: Traditional
Product code: IZL. Advisory committee: Radiology. Type: Traditional
Product code: NFO. Advisory committee: Neurology. Type: Special
Product code: ITH. Advisory committee: Physical Medicine. Type: Traditional
Product code: LTT. Advisory committee: Microbiology. Type: Traditional
Product code: PNR. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: HIH. Advisory committee: Obstetrics/Gynecology. Type: Special
Product code: MBI. Advisory committee: Orthopedic. Type: Traditional
Product code: OBO. Advisory committee: Ophthalmic. Type: Traditional
Product code: OWW. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: ODG. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: EBW. Advisory committee: Dental. Type: Special
Product code: LHI. Advisory committee: General Hospital. Type: Traditional