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18,004 catalysts · 4,728 grant · 3,603 8k filing · 2,593 approval · 1,945 device 510k · 1,575 device recall · 1,351 device pma
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18,004 catalysts · 4,728 grant · 3,603 8k filing · 2,593 approval · 1,945 device 510k · 1,575 device recall · 1,351 device pma
Sponsor: IMMEDICA PHARMA. Form: SUSPENSION. Route: ORAL
Sponsor: COVIS. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: PIRAMAL CRITICAL. Form: LIQUID. Route: INHALATION
Sponsor: CELLTRION. Form: INJECTABLE. Route: INJECTION
Product code: GEH. Advisory committee: General, Plastic Surgery. Type: Special
Product code: HHK. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Special
Product code: FBK. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: FMI. Advisory committee: General Hospital. Type: Traditional
Product code: NHA. Advisory committee: Dental. Type: Traditional
Product code: GEH. Advisory committee: General, Plastic Surgery. Type: Special
Product code: QHH. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: DSB. Advisory committee: Cardiovascular. Type: Traditional
Product code: EKX. Advisory committee: Dental. Type: Traditional
Product code: QEW. Advisory committee: Cardiovascular. Type: Traditional
Product code: GCJ. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: GAT. Advisory committee: General, Plastic Surgery. Type: Special
Product code: MRW. Advisory committee: Unknown. Type: Traditional
Product code: NVK. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: KGN. Advisory committee: Unknown. Type: Traditional
Supplement type: 30-Day Notice. Product code: QSK. Advisory committee: CV. Decision: OK30
Supplement type: Real-Time Process. Product code: MCM. Advisory committee: EN. Decision: APPR
Supplement type: 30-Day Notice. Product code: MHY. Advisory committee: NE. Decision: OK30
Supplement type: 30-Day Notice. Product code: MDS. Advisory committee: CH. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWR. Advisory committee: CV. Decision: OK30
Supplement type: Real-Time Process. Product code: PGQ. Advisory committee: EN. Decision: APPR
Supplement type: 30-Day Notice. Product code: DYE. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: DXY. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: OZO. Advisory committee: CH. Decision: OK30
Supplement type: 30-Day Notice. Product code: MRM. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWR. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: SFI. Advisory committee: CH. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MOZ. Advisory committee: OR. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: OAD. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: OZP. Advisory committee: CH. Decision: OK30
Supplement type: 30-Day Notice. Product code: MRM. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NPV. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NPT. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: QON. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: OTL. Advisory committee: OP. Decision: OK30
Supplement type: 30-Day Notice. Product code: LKK. Advisory committee: HO. Decision: OK30
Supplement type: 30-Day Notice. Product code: EZW. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: NKE. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LGW. Advisory committee: NE. Decision: OK30
VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7. — Reason: Affected system contains components that do not meet the required distance between electrodes for compliance with the IEC 60601-1 standard for medical electrical equipment. — Status: Ongoing
Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M used with RADspeed, SonialVision and FLUOROspeed Systems The ceiling type x-ray tube support CH-200 is used to hold the X-ray tube and collimator to position the X-ray tube unit. This unit is used for radiographic examinations of whole body except mammography when combined with an X-ray high voltage generator, an X-ray tube unit, an X-ray collimator, and if necessary, an X-ray radiography stand, an X-ray radiography table, and digital radiography system. — Reason: Due to an issue (potential breakage) with the shaft for the mounting of the X-ray tube assembly that could potentially result assembly coming off the rotating shaft. — Status: Ongoing
Sponsor: ARGENX BV. Form: INJECTABLE. Route: INJECTION