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12,432 catalysts · 3,404 8k filing · 2,370 grant · 1,843 approval · 1,245 device 510k · 1,000 device adverse event · 880 device pma
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12,432 catalysts · 3,404 8k filing · 2,370 grant · 1,843 approval · 1,245 device 510k · 1,000 device adverse event · 880 device pma
Product code: IOR. Advisory committee: Physical Medicine. Type: Traditional
Product code: FFX. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: DXH. Advisory committee: Cardiovascular. Type: Traditional
Product code: KLE. Advisory committee: Dental. Type: Traditional
Product code: LRK. Advisory committee: Dental. Type: Traditional
Product code: MYE. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: PBF. Advisory committee: Orthopedic. Type: Traditional
Product code: HRX. Advisory committee: Orthopedic. Type: Traditional
Product code: KXK. Advisory committee: Radiology. Type: Traditional
Product code: JTN. Advisory committee: Microbiology. Type: Traditional
Product code: BZD. Advisory committee: Anesthesiology. Type: Traditional
Supplement type: Normal 180 Day Track. Product code: OAD. Advisory committee: CV. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: LPM. Advisory committee: OP. Decision: APPR
Supplement type: Real-Time Process. Product code: MIH. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: SFI. Advisory committee: CH. Decision: OK30
Supplement type: 30-Day Notice. Product code: MDS. Advisory committee: CH. Decision: OK30
Supplement type: 30-Day Notice. Product code: OZP. Advisory committee: CH. Decision: OK30
BVI Leos Laser and Endoscopy System. Model Number: OME6000U. — Reason: Manufacturing deviation in which the ferrites specified for the USB cable assembly linking the Nurse Monitor touchscreen to the System Controller were not installed as intended. The omission of the ferrites on the USB communication cable results in non-conformance to the design specifications, which require two ferrites (one at each end of the cable). — Status: Ongoing
Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300 — Reason: The affected lots show a decline in performance over time, which may lead to false-negative results. — Status: Ongoing
LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471 — Reason: A potential issue associated with LUMINOS Lotus Max and Luminos dRF Max systems with software version VF11 with bucky wall stand for mobile detectors and without ceiling stand .When switching quickly between organ programs (OGPs) the collimation may be incorrect. — Status: Ongoing
Brand Name: LimFlow Vector Product Name: LimFlow Vector Model/Catalog Number: VT-US-23 — Reason: Incorrect expiration date — Status: Ongoing
AI grant. $49,538. PI: Amber Bahr
HD grant. $45,988. PI: Julia Marie Hartman
HL grant. $241,702. PI: MEI-ZHEN CUI
Sponsor: MERCK SHARP DOHME. Form: INJECTABLE. Route: INJECTION
Sponsor: LANNETT CO INC. Form: TABLET. Route: ORAL
Sponsor: LANNETT CO INC. Form: TABLET. Route: ORAL
Sponsor: AMNEAL. Form: SOLUTION. Route: INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Sponsor: CAPLIN. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: TEVA PHARMS USA INC. Form: INSERT. Route: VAGINAL
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Product code: POK. Advisory committee: Radiology. Type: Traditional
Product code: DXH. Advisory committee: Cardiovascular. Type: Traditional
Product code: JOW. Advisory committee: Cardiovascular. Type: Traditional
Product code: OVD. Advisory committee: Orthopedic. Type: Traditional
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: NCG. Advisory committee: Neurology. Type: Traditional
Product code: EIH. Advisory committee: Dental. Type: Abbreviated
Supplement type: 30-Day Notice. Product code: OZP. Advisory committee: CH. Decision: OK30
Supplement type: Real-Time Process. Product code: MHY. Advisory committee: NE. Decision: APPR
Supplement type: 30-Day Notice. Product code: MDS. Advisory committee: CH. Decision: OK30
Product code: JXK. Advisory committee: NE. Decision: APPR
Supplement type: Panel Track. Product code: SGU. Advisory committee: NE. Decision: APPR
Supplement type: 30-Day Notice. Product code: SFI. Advisory committee: CH. Decision: OK30
Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Number: 722229. 2. Azurion 3 M15. Model Number: 722230. 3. Azurion 5 M12. Model Number: 722231. 4. Azurion 5 M20. Model Number: 722232. 5. Azurion 7 B12. Model Number: 722235. 6. Azurion 7 B20. Model Number: 722236. 7. Azurion 7 M12. Model Number: 722233. 8. Azurion 7 M20. Model Number: 722234. — Reason: Nine (9) identified software issues which may result in the following: loss of X-ray after Pedal Tap, loss of X-ray after Phase Fault, missing live X-ray on the FlexVision monitor, system continues to restart, AMD triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after start-up, misalignment of Marker Tool Overlay, longitudinal position error. — Status: Ongoing
Brand Name: HFD100 Product Name: Head Fixation Device HFD100 Model/Catalog Number: 119695-000, 119629-000, 119630-000, 113803-000, 113803-600, 113802-000, 113802-600 Software Version: Not Applicable Product Description: The HFD100 Head Fixation Device provides rigid skeletal fixation within the optimal imaging envelope while introducing minimal artifacts in the acquired images. There are two different assemblies for the HFD100. The standard HFD100 is equipped with a table adapter for use with either the operating room table or the angiography table. For sites with a Hill-Rom TruSystem 7500 Hybrid Neuro MR Operating Table (ORT400), the HFD100 has a split block clamp assembly (Trumpf Mount Clamp Assembly) which connects directly to the table back section. The HFD100 system is also comprised of the linkage components to mount the skull clamp to the table adapter, and the 3-pin skull clamp. The linkage system is used to position the skull clamp in the necessary position, without colliding with the magnet bore. Component: Not a component. — Reason: Torque screw may crack or separate. If used, an affected screw could lead to inadequate head stabilization, compromised surgical precision, procedural delays, requirement for alternate head fixation methods, and risk of patient injury. — Status: Ongoing