calendar
19,155 catalysts · 4,728 grant · 3,208 8k filing · 2,679 approval · 2,475 device 510k · 2,000 device recall · 1,737 device pma
next 91 dayslessmore
MonWedFri
19,155 catalysts · 4,728 grant · 3,208 8k filing · 2,679 approval · 2,475 device 510k · 2,000 device recall · 1,737 device pma
X3-1 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing
Product code: QDQ. Advisory committee: Radiology. Type: Traditional
Product code: JAK. Advisory committee: Radiology. Type: Traditional
Product code: FGE. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: PHX. Advisory committee: Orthopedic. Type: Traditional
Product code: FED. Advisory committee: Gastroenterology, Urology. Type: Special
Product code: MQH. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: QPL. Advisory committee: Neurology. Type: Traditional
Product code: ERL. Advisory committee: Ear, Nose, Throat. Type: Traditional
Product code: MGZ. Advisory committee: Cardiovascular. Type: Traditional
Product code: GZF. Advisory committee: Neurology. Type: Traditional
Product code: FMF. Advisory committee: General Hospital. Type: Traditional
Product code: KPS. Advisory committee: Radiology. Type: Special
Product code: DZE. Advisory committee: Dental. Type: Traditional
Product code: JKA. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: ODP. Advisory committee: Orthopedic. Type: Traditional
Product code: MNR. Advisory committee: Anesthesiology. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: FZP. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: ONF. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: PSZ. Advisory committee: Microbiology. Type: Traditional
Product code: KIF. Advisory committee: Dental. Type: Traditional
Product code: LJE. Advisory committee: Unknown. Type: Traditional
Supplement type: 30-Day Notice. Product code: QZI. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: PRL. Advisory committee: CV. Decision: APPR
epoc BGEM BUN Test Card [25pk]. Material Number: 10736515. — Reason: Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in some epoc test card lots. All other analytes are performing as intended. The observed average bias for sodium was -4.4 mmol/L. The maximum bias observed was -14 mmol/L, which occurred at a higher sodium concentration around 150 mmol/L. No positive bias has been observed. Quality Control (QC) fluid may or may not detect the issue depending on the bias magnitude and the frequency of QC testing. — Status: Ongoing
Carotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding Stent, stent and stent delivery system. Material numbers: H7493915010240 CAROTID WALLSTENT MONORAIL 10.0-24; H7493915010310 CAROTID WALLSTENT MONORAIL 10.0-31; H749391506220 CAROTID WALLSTENT MONORAIL 6.0-22; H749391508210 CAROTID WALLSTENT MONORAIL 8.0-21; H749391508290 CAROTID WALLSTENT MONORAIL 8.0-29; H965SCH647010 CAROTID WALLSTENT MONORAIL 6.0-22; H965SCH647070 CAROTID WALLSTENT MONORAIL 8.0-21; H965SCH647080 CAROTID WALLSTENT MONORAIL 8.0-29; H965SCH647090 CAROTID WALLSTENT MONORAIL 8.0-36; H965SCH647120 CAROTID WALLSTENT MONORAIL 10.0-24; H965SCH647130 CAROTID WALLSTENT MONORAIL 10.0-31; H965SCH647140 CAROTID WALLSTENT MONORAIL 10.0-37; M001719000 CAROTID WALLSTENT MR 6X22 5F 135CM; M001719010 CAROTID WALLSTENT MR 8X21 5F 135CM; M001719020 CAROTID WALLSTENT MR 8X29 5F 135CM; M001719030 CAROTID WALLSTENT MR 8X36 5F 135CM; M001719040 CAROTID WALLSTENT MR 10X24 5.9F 135CM; M001719050 CAROTID WALLSTENT MR 10X31 5.9F 135CM; M001719060 CAROTID WALLSTENT MR 10X37 5.9F 135CM; — Reason: Certain batches are being removed due to an increase in complaints received in which physicians encountered greater than anticipated resistance while attempting to withdraw the stent delivery system (SDS) from the guidewire or embolic protection device (EPD) after successful stent deployment. The most serious potential adverse health consequence is stroke. Other risks include delay to procedure, vessel injury, vessel spasm, or stent disruption/damage necessitating additional intervention. — Status: Ongoing
Product code: MAX. Advisory committee: Orthopedic. Type: Traditional
Product code: LZA. Advisory committee: General Hospital. Type: Traditional
Product code: MAX. Advisory committee: Orthopedic. Type: Traditional
Product code: OWB. Advisory committee: Radiology. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Sponsor: PFIZER INC. Form: SOLUTION. Route: INJECTION
Supplement type: 30-Day Notice. Product code: NPT. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NPV. Advisory committee: CV. Decision: OK30
The Medline General Surgery Tray is customized to meet requirements of the hospitals and health care professionals utilizing them. The kit is provided sterile, single-use and includes a range of components dependent upon the specific procedure. These kits will be assembled using Medline and other manufacturers medical device components and drug components in some cases. Customers specify the kit contents, quantity, and placement of individual items in the kit. — Reason: Affected kits contain recalled Stryker Color Cuff Sterile Disposable Tourniquet Cuffs. Stryker Instruments initiated this recall due to a potential manufacturing defect in which the flange may detach from the bladder at the welded connection point. This detachment compromises the cuff's ability to maintain adequate air pressure, potentially resulting in tourniquet failure and increased risk of patient hemorrhaging. — Status: Ongoing
Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise Deep Stimulation System used with the Surgical Implant Manual — Reason: Resistance and difficulties could occur while closing the retaining clip locking mechanism, which is part of a burr hole cover kit, which is part of a Deep Brain Stimulation (DBS) system, which may lead to procedural delay, or lead-migration-which may require additional surgery. — Status: Ongoing
Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09 — Reason: Wire break(s) have occurred in rechargeable deep brain stimulation implantable pulse generators, implanted in the submuscular pectoral location. Wire breaks prevent successful stimulation, thus requiring device removal/replacement and users may experience high monopolar impedances, undesired sensation, loss of therapy, return of symptoms and/or Bluetooth connectivity challenges. — Status: Ongoing
BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD — Reason: Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts. — Status: Ongoing
BD Trucount Controls, 30 Test - REF: 340335 — Reason: Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts. — Status: Ongoing
BD Alaris Pump Infusion Sets REF: 10013186, BD Alaris Pump Infusion Set, Back Check Valve, 3 SmartSite Y-sites LVP 60D DEHP FREE 3SS CV; REF: 2452-0007, BD Alaris Pump Infusion Set, 2 Back Check Valves, 3 SmartSite Y-sitesAS LVP 10D 3SS 2CV; REF: 2204-0007, BD Alaris Pump Infusion SetAS LVP 20D; REF: 24001-0007, BD Alaris Pump Infusion Set, Back Check Valve, SmartSite Y-siteAS LVP 20D SS CV; REF: 10015012, BD Alaris Pump Infusion Burette Set, 0.2 Micron Filter, Smallbore Tubing, SmartSite Port (Burette), SmartSite Y-siteAS LVP BUR 20D PE-Lined SMBORE SS 0.2M; REF: 2432-0007, BD Alaris Pump Infusion Set, 0.2 Micron Filter, Back Check Valve, 3 SmartSite Y-sitesAS LVP 20D 3SS 0.2M CV; REF: 2434-0007, BD Alaris Pump Infusion Set, 0.2 Micron Filter, Back Check Valve, SmartSite Y-siteAS LVP 20D SS 0.2M CV; REF: 2202-0007, BD Alaris Pump Infusion Set, 1.2 Micron FilterAS LVP 20D 1.2M; REF: 11426965, BD Alaris Pump Infusion Set, Back Check Valve, 5 SmartSite Y-sitesAS LVP 20D CV; REF: 10561554, BD Alaris Pump Infusion Set, 15 Micron Filter, Back Check Valve, 3 SmartSite Y-sitesAS LVP 20D DEHP FREE 3SS 15M CV; REF: 10863358, BD Alaris Pump Infusion Set, 15 Micron FilterAS LVP 20D DEHP FREE 15M; REF: 11171447, BD Alaris Pump Infusion Set, 2 Back Check Valves, 3 SmartSite Y-sitesAS LVP 20D 3SS 2CV; REF: 11532269, BD Alaris Pump Infusion Set, 0.2 Micron Filter, Back Check Valve, PE Lined Tubing, 2 SmartSite Y-sitesAS LVP 20D PE-LINED 2SS 0.2M CV; REF: 10010454, BD Alaris Pump Infusion Set, 0.2 Micron Filter, PE Lined Tubing, SmartSite Y-siteAS LVP 20D PE-LINED TUBING SS 0.2M; REF: 2465-0007, BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, 0.2 Micron Filter, Low Sorbing Tubing (PE Lined), SmartSite Y-siteAS LVP SS BAG 20D PE-Lined SS 0.2M; REF: 10010453, ASBD Alaris Pump Infusion Set, 1.2 Micron Filter, PE Lined Tubing, SmartSite Y-site LVP 20D PE-LINED TUBING SS 1.2M REF: 11419365, BD Alaris" Pump Infusion Set, Back Check Valve, Manifold, 3-Way Stopcock, 5 SmartSite" Y-sites REF: 10813621, BD Alaris" Pump Infusion Set, Back Check Valve, 3 Ganged 4-Way Stopcocks, 4 SmartSite" Y-sites REF: 2423-0007, BD Alaris" Pump Infusion Set, Back Check Valve, 2 Ganged 4-Way Stopcocks, 4 SmartSite" Y-sites REF: 10015896, BD Alaris" Pump Infusion Set, Back Check Valve, 2 Ganged 4-Way Stopcocks, 3 SmartSite" Y-sites REF: 24010-0007T, BD Alaris" Pump Infusion Set, Bonded Texium", Closed Male Luer with Priming Cap, Back Check Valve, 3 SmartSite" Y-sites REF: 10010483, BD Alaris" Pump Infusion Set, Vented Syringe Adapter, Smallbore Tubing REF: 2403-0007, BD Alaris" Pump Infusion Set, Half Set, SmartSite" Y-site REF: 24301-0007T, BD Alaris" Pump Infusion Set, SmartSite" Bag Access Non-Vented, 0.2 Micron Filter, PE Lined Tubing, Bonded Texium" Closed Male Luer with Priming Cap, SmartSite" Y-site — Reason: Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume. — Status: Ongoing
BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions — Reason: Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume. — Status: Ongoing
Product code: QIH. Advisory committee: Radiology. Type: Special
Product code: LZA. Advisory committee: General Hospital. Type: Traditional
Product code: NKB. Advisory committee: Orthopedic. Type: Special
Product code: FED. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: FMI. Advisory committee: General Hospital. Type: Traditional
Product code: JWH. Advisory committee: Orthopedic. Type: Special
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional