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10,225 catalysts · 3,350 8k filing · 2,091 grant · 1,128 approval · 1,000 device adverse event · 848 device 510k · 610 device pma
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10,225 catalysts · 3,350 8k filing · 2,091 grant · 1,128 approval · 1,000 device adverse event · 848 device 510k · 610 device pma
Product code: MQF. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: CEM. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: OWN. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: OWN. Advisory committee: Gastroenterology, Urology. Type: Special
Product code: KWQ. Advisory committee: Orthopedic. Type: Special
Product code: OLO. Advisory committee: Neurology. Type: Traditional
Product code: FPA. Advisory committee: General Hospital. Type: Traditional
Product code: NFW. Advisory committee: Clinical Toxicology. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Supplement type: 135 Review Track For 30-Day Notice. Product code: NPV. Advisory committee: CV. Decision: APPR
Supplement type: 135 Review Track For 30-Day Notice. Product code: LWR. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: NPV. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MNB. Advisory committee: OB. Decision: OK30
Supplement type: 30-Day Notice. Product code: MTF. Advisory committee: IM. Decision: OK30
Supplement type: 30-Day Notice. Product code: PJY. Advisory committee: OR. Decision: OK30
Supplement type: 30-Day Notice. Product code: NGV. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NGV. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LOK. Advisory committee: IM. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: NVN. Advisory committee: CV. Decision: APPR
Supplement type: 135 Review Track For 30-Day Notice. Product code: DYE. 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: MHY. Advisory committee: NE. Decision: OK30
Supplement type: 30-Day Notice. Product code: QPT. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWP. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NIK. Advisory committee: CV. Decision: OK30
Supplement type: Special (Immediate Track). Product code: QVG. Advisory committee: CV. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: QAN. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: NPT. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NPW. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LGW. Advisory committee: NE. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MAE. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LKK. Advisory committee: HO. Decision: OK30
Supplement type: 135 Review Track For 30-Day Notice. Product code: NPT. Advisory committee: CV. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: QZI. Advisory committee: CV. Decision: APPR
Supplement type: 135 Review Track For 30-Day Notice. Product code: LWR. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: MTG. Advisory committee: IM. Decision: OK30
Supplement type: 135 Review Track For 30-Day Notice. Product code: NPV. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: MAQ. Advisory committee: MI. Decision: OK30
Product code: SGK. Advisory committee: OR. Decision: APPR
Supplement type: Special (Immediate Track). Product code: NJL. Advisory committee: OR. Decision: APPR
Supplement type: 30-Day Notice. Product code: NVZ. Advisory committee: CV. Decision: OK30
Supplement type: 135 Review Track For 30-Day Notice. Product code: DYE. Advisory committee: CV. Decision: APPR
Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILEEO. For surgical use — Reason: Probes may rupture/burst during activation — Status: Ongoing
Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use — Reason: Probes may rupture/burst during activation — Status: Ongoing
Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443. — Reason: The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors. — Status: Ongoing
Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140. — Reason: The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors. — Status: Ongoing
Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340. — Reason: The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors. — Status: Ongoing