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19,831 catalysts · 4,728 grant · 3,301 8k filing · 2,768 device 510k · 2,721 approval · 2,000 device recall · 1,955 device pma
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19,831 catalysts · 4,728 grant · 3,301 8k filing · 2,768 device 510k · 2,721 approval · 2,000 device recall · 1,955 device pma
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
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Brand Name: Ultra IABP Catheter Kit Product Name: Ultra IABP Catheter Kit Model/Catalog Number: IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, and IMU7F-20 Software Version: Not applicable Product Description: The Insightra Ultra IABP Catheter Kit is a 7 French catheter available with either a 40, 35, 30, 25, or 20 cc balloon. The catheter has two lumens and is designed to provide counterpulsation cardiac assist therapy. The outer lumen is a channel for helium used to inflate and deflate the balloon. The inner lumen is used for a guidewire and blood pressure measurement. It is packaged as a convenience kit with accessories (one-way valve, 50 cc syringe, guide wires, introducer needle, dilator, pressure tubing, Datascope & Arrow adaptors). The balloon inflation and deflation cycle is synchronized (using a commercially available control console) with the ECG or arterial pressure to provide counterpulsation synchronized with the heartbeat. It is intended to increase coronary perfusion, decrease the workload of the left ventricle and allow healing of the myocardium Component: No — Reason: Device contains indications for use and device compatibility claims that have not be reviewed and approved for safety and effectiveness by the FDA. Instructions for use are not consistent with product training. — Status: Terminated
Product code: OBJ. Advisory committee: Cardiovascular. Type: Traditional
Sponsor: ESPERION THERAPS INC. Form: TABLET. Route: ORAL
Sponsor: ESPERION THERAPS INC. Form: TABLET. Route: ORAL
Sponsor: ESPERION THERAPS INC. Form: TABLET. Route: ORAL
Sponsor: ESPERION THERAPS INC. Form: TABLET. Route: ORAL
Sponsor: STRIDES PHARMA. Form: CAPSULE. Route: ORAL
Sponsor: STRIDES PHARMA. Form: CAPSULE. Route: ORAL
Supplement type: Normal 180 Day Track No User Fee. Product code: PGE. Advisory committee: CH. Decision: APPR
Supplement type: 30-Day Notice. Product code: MNQ. Advisory committee: AN. Decision: OK30
Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic, Replacement, Refurbished, REF: 1003808; t: slim X2, Basal-IQ, mg/dl, REF: 1004219; Pump, t:slim X2, Clinical Use Only, REF: 1004484; Pump, t:slim X2, Control-IQ, REF: 1005611; Pump, t:slim X2, Control-IQ, mmoUL, Refurbished Replacement, REF: 1005613; Pump, t:slim X2, Control-IQ, mg/dl, REF: 1005615; Pump, t:slim X2, Control-IQ, mg/dl, Refurbished Replacement, REF: 1005617; Pump, t:slim X2, Basal-IQ 6.4, Refurbished Replacement, REF: 1006379; Pump, t:slim X2, Control-IQ 7.4, REF: 1006402; Pump, t:slim X2, Control-IQ 7.4, Replacement, REF: 1006406; Pump, t:slim X2, Control-IQ 7.4, REF: 1006408; Pump, t:slim X2, Basal-IQ, , REF: 1006419; Pump, t:slim X2, Basal-IQ, mg/dL, REF: 1006420; Pump, t:slim X2, Basal-IQ, mmoUL, Refurbished Replacement, REF: 1006535; Pump, t:slim X2, Basal-IQ, mg/dL, Refurbished Replacement, REF: 1006537; Pump, t:slim X2, Control-IQ, mg/dl , Replacement, REF: 1008255; Pump, t:slim X2, Control-IQ, mmoUL, Replacement, REF: 1008256; Pump, t:slim X2, Basal-IQ, mmoUL, Replacement, REF: 1008257; Pump, t:slim X2, Basal-IQ, mg/dl ,Replacement, REF: 1008258; Pump, t:slim X2, Basal-IQ, REF: 1010004; Pump, t:slim X2, Basal-IQ, Replacement, REF: 1010005; Pump, t:slim X2, Basal-IQ, Medicare, REF: 1010006; Pump, t:slim X2, Basal-IQ, Medicare, REF: 1010007; Pump, t:slim X2, Control-IQ, REF: 1010009; Pump, t:slim X2, Control-IQ Replacement, REF: 1010010; Pump, t:slim X2, Control-IQ, Medicare, REF: 1010011; Pump, t:slim X2, Control-IQ, Refurbished Replacement, REF: 1010012; Pump, t:slim X2, Control-IQ, REF: 1012867; Pump, t:slim X2, Control-IQ, Medicare, REF: 1012868; Pump, t:slim X2, Control-IQ, Replacement, REF: 1012869; Pump, t:slim X2, Control-IQ 7.8, REF: 1013195; Pump, t:slim X2, Control-IQ 7.8, Medicare, REF: 1013196; Pump, t :slim X2, Control-IQ 7.8, Replacement, REF: 1013197; Pump, t:slim X2, Control-IQ 7.8, Refurbished Replacement, REF: 1013198 — Reason: Insulin pumps manufactured with speakers from Revision A and B may malfunction ("Malfunction 16") which prevents audible alerts and causes the pumps to become inoperable and stop infusing insulin which could result in a hyperglycemic event, which may lead to injury and/or hospitalization. — Status: Ongoing
STA-Liquid Anti-Xa 4. Model/Catalog Number: 00311US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite analyzers, for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate. — Reason: Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications. — Status: Ongoing
STA Satellite. Product Code: All references. All software versions. The STA Satellite is a fully automated benchtop analyzer capable of simultaneously performing clotting, chromogenic, and immunologic assays. — Reason: Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications. — Status: Ongoing
STA-Liquid Anti-Xa 8. Model/Catalog Number: 00322US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite analyzers, for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate. — Reason: Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications. — Status: Ongoing
STA - Fibrinogen 5. Model/Catalog Number: 00674. The STA - Fibrinogen 5 kit is intended for use with the analyzers of the STA-R, STA Compact and STA Satellite families for the quantitative determination of fibrinogen levels in human citrated plasma by the clotting method of Clauss. — Reason: Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications. — Status: Ongoing
Brand Name: Finesse BTK Multicath Product Name: Injectable Angioplasty Balloon Catheter Model/Catalog Number: FS252251502 Product Description: 5 French sheath, 0.014" guidewire compatible over-the-wire injectable angioplasty balloon catheter, balloon diameter 2.5mm, balloon length 225mm, catheter working length 150cm Component: NA — Reason: Potential for the balloon in the device to not meet burst specifications. — Status: Ongoing
Brand Name: CELSITE Product Name: CELSITE BABYPORT SET PUR 4,5F IV USA Model/Catalog Number: 5433742 Software Version: N/A Product Description: CELSITE BABYPORT SET PUR 4,5F IV USA Component: N/A — Reason: The potential for minor injury such as damage to the vessel and/or tearing of the vessel wall. — Status: Ongoing
Product code: GJS. Advisory committee: Hematology. Type: Traditional
Sponsor: CHATTEM SANOFI. Form: SOLUTION. Route: ORAL
Supplement type: 30-Day Notice. Product code: HQL. Advisory committee: OP. Decision: OK30
Supplement type: 30-Day Notice. Product code: MHY. Advisory committee: NE. Decision: OK30
Supplement type: 30-Day Notice. Product code: HQL. Advisory committee: OP. Decision: OK30