calendar
19,803 catalysts · 4,728 grant · 3,350 8k filing · 2,737 device 510k · 2,721 approval · 2,000 device recall · 1,916 device pma
next 91 dayslessmore
MonWedFri
19,803 catalysts · 4,728 grant · 3,350 8k filing · 2,737 device 510k · 2,721 approval · 2,000 device recall · 1,916 device pma
Product code: QME. Advisory committee: Cardiovascular. Type: Traditional
Product code: EOQ. Advisory committee: Ear, Nose, Throat. Type: Traditional
Supplement type: Real-Time Process. Product code: MKJ. Advisory committee: CV. Decision: APPR
Product code: QZI. Advisory committee: CV. Decision: APPR
Supplement type: Special (Immediate Track). Product code: LNM. Advisory committee: GU. Decision: APPR
Supplement type: Real-Time Process. Product code: LWS. Advisory committee: CV. Decision: APPR
Supplement type: Panel Track. Product code: NPT. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: DSQ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MKQ. Advisory committee: PA. Decision: OK30
Supplement type: Real-Time Process. Product code: NVN. Advisory committee: CV. Decision: APPR
Supplement type: Real-Time Process. Product code: NIK. Advisory committee: CV. Decision: APPR
The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement. — Reason: Vision RT is informing customers of an omission identified in the Instructions for Use for AlignRT InBore systems. Information identifying the lasers and their characteristics was omitted from the Instructions for Use for the subject system as required by 21 CFR 1040,10(h), via conformance with recognized consensus standard IEC 60825-1 Ed. 3 (FDA Laser Notice 56). — Status: Ongoing
Product code: HGM. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: NFT. Advisory committee: Clinical Toxicology. Type: Traditional
Product code: HWC. Advisory committee: Orthopedic. Type: Traditional
Product code: LZA. Advisory committee: General Hospital. Type: Traditional
Product code: FRO. Advisory committee: Unknown. Type: Traditional
Product code: MQL. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: MWI. Advisory committee: Cardiovascular. Type: Traditional
Product code: DXF. Advisory committee: Cardiovascular. Type: Traditional
Product code: QOF. Advisory committee: Microbiology. Type: Traditional
Product code: JWY. Advisory committee: Microbiology. Type: Traditional
Product code: NUH. Advisory committee: Neurology. Type: Special
Product code: CCK. Advisory committee: Anesthesiology. Type: Traditional
Product code: KWQ. Advisory committee: Orthopedic. Type: Traditional
Product code: JAK. Advisory committee: Radiology. Type: Traditional
Product code: QEW. Advisory committee: Cardiovascular. Type: Traditional
Product code: MNR. Advisory committee: Anesthesiology. Type: Special
Product code: NKB. Advisory committee: Orthopedic. Type: Special
Product code: PGY. Advisory committee: Radiology. Type: Abbreviated
Product code: LYZ. Advisory committee: General Hospital. Type: Traditional
Product code: PHX. Advisory committee: Orthopedic. Type: Special
Product code: NAY. Advisory committee: Gastroenterology, Urology. Type: Special
Product code: NGX. Advisory committee: Physical Medicine. Type: Special
Product code: CBK. Advisory committee: Anesthesiology. Type: Traditional
Product code: KPR. Advisory committee: Radiology. Type: Traditional
Product code: QOG. Advisory committee: General Hospital. Type: Traditional
Supplement type: 30-Day Notice. Product code: MHY. Advisory committee: NE. Decision: OK30
Supplement type: Special (Immediate Track). Product code: QQK. Advisory committee: GU. Decision: APPR
Supplement type: 30-Day Notice. Product code: NCD. Advisory committee: MI. Decision: OK30
Supplement type: 30-Day Notice. Product code: LKK. Advisory committee: HO. Decision: OK30
Supplement type: 30-Day Notice. Product code: LOM. Advisory committee: MI. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: MKJ. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: EZW. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: QON. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: LOM. Advisory committee: MI. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: MKJ. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: LGW. Advisory committee: NE. Decision: OK30
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560. — Reason: There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room. — Status: Ongoing
Biograph mMR. Model Number: 10433372. — Reason: There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room. — Status: Ongoing