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19,123 catalysts · 4,728 grant · 3,350 8k filing · 2,678 approval · 2,431 device 510k · 1,921 device recall · 1,709 device pma
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19,123 catalysts · 4,728 grant · 3,350 8k filing · 2,678 approval · 2,431 device 510k · 1,921 device recall · 1,709 device pma
Multi Joystick R-net. Electrical wheelchair component. — Reason: Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary neutral check and the wheelchair producing unintended movement upon power-up when the joystick is out of neutral. — Status: Ongoing
Product code: NFO. Advisory committee: Neurology. Type: Traditional
Product code: EIH. Advisory committee: Dental. Type: Traditional
Product code: KNW. Advisory committee: Gastroenterology, Urology. Type: Special
Product code: DPS. Advisory committee: Cardiovascular. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Special
Product code: DWF. Advisory committee: Cardiovascular. Type: Special
Product code: OVD. Advisory committee: Orthopedic. Type: Traditional
Product code: MBI. Advisory committee: Orthopedic. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: MRW. Advisory committee: Unknown. Type: Special
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Sponsor: VIVUS LLC. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL
Sponsor: MICRO LABS LTD INDIA. Form: TABLET. Route: ORAL
Supplement type: 30-Day Notice. Product code: MGB. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: SER. Advisory committee: PA. Decision: APPR
Supplement type: 30-Day Notice. Product code: MDS. Advisory committee: CH. Decision: OK30
Supplement type: 30-Day Notice. Product code: NKM. Advisory committee: CV. Decision: OK30
Supplement type: Real-Time Process. Product code: LWP. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: PZE. Advisory committee: CH. Decision: OK30
Supplement type: Real-Time Process. Product code: MKJ. Advisory committee: CV. Decision: APPR
Supplement type: Real-Time Process. Product code: LWP. Advisory committee: CV. Decision: APPR
Supplement type: Real-Time Process. Product code: NKE. Advisory committee: CV. Decision: APPR
Supplement type: Real-Time Process. Product code: DSR. Advisory committee: CV. Decision: APPR
Supplement type: Real-Time Process. Product code: MKJ. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: LTI. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: DSQ. Advisory committee: CV. Decision: OK30
Supplement type: Real-Time Process. Product code: LTI. Advisory committee: GU. Decision: APPR
Blood Agar,5% Sheep Blood 100/PK, Product Number R01202 — Reason: The products may contain surface and subsurface contamination of Listeria monocytogenes. — Status: Ongoing
Plum Duo Infusion System, List Number: 400020401 — Reason: ICU Medical identified two sequences of programming events and alarm interactions that may cause the user interface to become unresponsive. — Status: Ongoing
BritePro Solo Single-Use Fiber Optic Mini Handle and Blade Ref: 040-02-0110U (Mac 1), 040-02-0120U (Mac 2), 040-02-0130U (Mac 3), 040-02-0131U (Mac 3 Strong Curve) 040-02-0140U (Mac 4), 040-02-0400U (Miller 00), 040-02-0410U (Miller 1), 040-02-0420U (Miller 2), 040-02-0430U (Miller 3), — Reason: Laryngoscope handles may not illuminate as intended. — Status: Ongoing
BritePro Solo Mini with Pro Miller Blade Size 1.5, REF:040-02-0415U — Reason: Laryngoscope handles may not illuminate as intended. — Status: Ongoing
BritePro Solo Single-Use Fiber Optic Laryngoscope Handle Refs:040-310AU and 040-310U — Reason: Laryngoscope handles may not illuminate as intended. — Status: Ongoing
Britepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handle REF:040-03-0000U — Reason: Laryngoscope handles may not illuminate as intended. — Status: Ongoing
Blood/MacConkey Biplate 100/PK, Product Number R02049 — Reason: The products may contain surface and subsurface contamination of Listeria monocytogenes. — Status: Ongoing
Strep Selective II Agar, Product Number R01859 — Reason: The products may contain surface and subsurface contamination of Listeria monocytogenes. — Status: Ongoing
BritePro Solo Single-Use Fiber Optic Handle and Blade Refs: 040-331U (Mac 1), 040-332U (Mac 2), 040-333U (Mac 3), 040-335U (Mac 3.5) 040-334U (Mac 4), 040-341U (Miller 1), 040-342U (Miller 2), 040-343U (Miller 3), 040-344U (Miller 4), 040-361U (Phillips 1), 040-362U (Phillips 2) — Reason: Laryngoscope handles may not illuminate as intended. — Status: Ongoing
ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Canal filling stem implants. — Reason: Unidentified substance of unknown impact was identified on devices during a retrospective evaluation. — Status: Ongoing
BritePro Solo Mini Single-Use Fiber Optic Laryngoscope Handle REF:040-309U — Reason: Laryngoscope handles may not illuminate as intended. — Status: Ongoing
Blood/EMB, Levine 100/PK, Product Number R02041 — Reason: The products may contain surface and subsurface contamination of Listeria monocytogenes. — Status: Ongoing
ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS SEGMENTAL STEM CANAL FILLING STRAIGHT SLOTTED SPLINED 2/3 PLASMA. Canal filling stem implants. — Reason: Unidentified substance of unknown impact was identified on devices during a retrospective evaluation. — Status: Ongoing
ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem implants. — Reason: Unidentified substance of unknown impact was identified on devices during a retrospective evaluation. — Status: Ongoing
Product code: OHT. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: JFB. Advisory committee: Physical Medicine. Type: Traditional
Product code: GCJ. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: LNH. Advisory committee: Radiology. Type: Special
Product code: HTN. Advisory committee: Orthopedic. Type: Traditional
Product code: EMA. Advisory committee: Dental. Type: Traditional
Product code: IYO. Advisory committee: Radiology. Type: Traditional
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional