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19,760 catalysts · 4,728 grant · 3,230 8k filing · 2,768 device 510k · 2,721 approval · 2,000 device recall · 1,955 device pma
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19,760 catalysts · 4,728 grant · 3,230 8k filing · 2,768 device 510k · 2,721 approval · 2,000 device recall · 1,955 device pma
Description/REF: BD PYXIS MEDBANK MINI 1FH-1FM/169-137, BD PYXIS MEDBANK MINI 4HM/169-113, BD PYXIS MEDBANK MINI 4HH/169-112, BD PYXIS MEDBANK MINI 3HH-1HM/169-111, BD PYXIS MEDBANK MINI 3HH-1FG/169-110, BD PYXIS MEDBANK MINI 2HM-1FM/169-109, BD PYXIS MEDBANK MINI 2HH-2HM/169-108, BD PYXIS MEDBANK MINI 2HH-1FM/169-107, BD PYXIS MEDBANK MINI 2HH-1FH/169-106, BD PYXIS MEDBANK MINI 2FM/169-105, BD PYXIS MEDBANK MINI 2FH/169-104, BD PYXIS MEDBANK MINI 1HH-3HM/169-103, BD PYXIS MEDBANK MINI 1HH-1HM-1FM/169-102, BD PYXIS MEDBANK MINI 1HH-1FH-1HM/169-101 , BD PYXIS MEDBANK MINI 1FH-2HH/155311-01, BD PYXIS MEDBANK MINI 4HH/155310-01, BD PYXIS MEDBANK MINI 1FH-1FM/155288-01, BD PYXIS MEDBANK MINI 4HM/155171-01, BD PYXIS MEDBANK MINI 3HH-1HM/155169-01, BD PYXIS MEDBANK MINI 3HH-1FG/155168-01, BD PYXIS MEDBANK MINI 2HM-1FM/155167-01, BD PYXIS MEDBANK MINI 2HH-2HM/155166-01, BD PYXIS MEDBANK MINI 2HH-1FM/155165-01, BD PYXIS MEDBANK MINI 2FM/155163-01, BD PYXIS MEDBANK MINI 1HH-3HM/155161-01, BD PYXIS MEDBANK MINI 1HH-1HM-1FM/155160-01, BD PYXIS MEDBANK MINI 1HH-1FH-1HM/155159-01, BD PYXIS MEDBANK MINI 2HM-1FM/139131-01, BD PYXIS MEDBANK MINI 1HH-1HM-1FM/139122-01, BD PYXIS MEDBANK MINI 3HH-1FG/139091-01, BD PYXIS MEDBANK MINI 1HH-1FH-1HM/138921-01, BD PYXIS MEDBANK MINI 4HM/138915-01, BD PYXIS MEDBANK MINI 1HH-3HM/138912-01, BD PYXIS MEDBANK MINI 4HH/138910-01, BD PYXIS MEDBANK MINI 3HH-1HM/138909-01, BD PYXIS MEDBANK MINI 2HH-1FH/138908-01, BD PYXIS MEDBANK MINI 2HH-2HM/138907-01, BD PYXIS MEDBANK MINI 2HH-1FM/138906-01, BD PYXIS MEDBANK MINI 2FM/138903-01, BD PYXIS MEDBANK MINI 2FH/138902-01, MEDBANK MINI MAIN/1147-00, MEDBANK MAIN/1137-00, BD PYXIS MEDBANK TWR MN 8HH-3FM/169-81, BD PYXIS MEDBANK TWR MN 8HH-3FH/169-80, BD PYXIS MEDBANK TWR MN 8HH-3FF/169-79, BD PYXIS MEDBANK TWR MN 8HH-2HM-2FM/169-78, BD PYXIS MEDBANK TWR MN 8HH-2FH-1FM/169-77, BD PYXIS MEDBANK TWR MN 8HH-1FH-2HM-1FM/169-76, BD PYXIS MEDBANK TWR MN 8HH-1FH-2FM/169-75, BD PYXIS MEDBANK TWR MN 7HH-1HM-3FM/169-74, BD PYXIS MEDBANK TWR MN 7FM/169-73, BD PYXIS MEDBANK TWR MN 7FH/169-72, BD PYXIS MEDBANK TWR MN 6HH-8HM/169-71, BD PYXIS MEDBANK TWR MN 6HH-6HM-1FM/169-70, BD PYXIS MEDBANK TWR MN 6HH-4HM-2FM/169-69, BD PYXIS MEDBANK TWR MN 6HH-4FM/169-68, BD PYXIS MEDBANK TWR MN 6HH-4FH /169-67, BD PYXIS MEDBANK TWR MN 6HH-2FH-2HM-1FM/169-66, BD PYXIS MEDBANK TWR MN 6HH-2FH-2FM/169-65, BD PYXIS MEDBANK TWR MN 6HH-1FH-3FM/169-64, BD PYXIS MEDBANK TWR MN 6HH-1FH-2HM-2FM/169-63, BD PYXIS MEDBANK TWR MN 6FH-1FM/169-62, BD PYXIS MEDBANK TWR MN 5HH-9HM/169-61, BD PYXIS MEDBANK TWR MN 5HH-3HM-3FM/169-60, BD PYXIS MEDBANK TWR MN 4HM-5FM/169-59, BD PYXIS MEDBANK TWR MN 4HH-8HM-1FM/169-58, BD PYXIS MEDBANK TWR MN 4HH-6HM-2FM/169-57, BD PYXIS MEDBANK TWR MN 4HH-5FM/169-56, BD PYXIS MEDBANK TWR MN 4HH-5FH /169-55, BD PYXIS MEDBANK TWR MN 4HH-4HM-3FM/169-54, BD PYXIS MEDBANK TWR MN 4HH-4FH-1FM/169-53, BD PYXIS MEDBANK TWR MN 4HH-3FH-2FM/169-52, BD PYXIS MEDBANK TWR MN 4HH-2HM-4FM/169-51, BD PYXIS MEDBANK TWR MN 4HH-2FH-3FM/169-50, BD PYXIS MEDBANK TWR MN 4HH-2FH-2HM-2FM/169-49, BD PYXIS MEDBANK TWR MN 4HH-1FH-6HM-1FM/169-48, BD PYXIS MEDBANK TWR MN 4HH-1FH-4HM-2FM/169-47, BD PYXIS MEDBANK TWR MN 4HH-1FH-4FM/169-46, BD PYXIS MEDBANK TWR MN 4HH-1FH-2HM-3FM/169-45, BD PYXIS MEDBANK TWR MN 4HH-10HM/169-44, BD PYXIS MEDBANK TWR MN 3HH-7HM-2FM/169-43, BD PYXIS MEDBANK TWR MN 3FH-4FM/169-42, BD PYXIS MEDBANK TWR MN 2HM-6FM/169-41, BD PYXIS MEDBANK TWR MN 2HH-8HM-2FM/169-40, BD PYXIS MEDBANK TWR MN 2HH-6HM-3FM/169-39, BD PYXIS MEDBANK TWR MN 2HH-6FM/169-38, BD PYXIS MEDBANK TWR MN 2HH-4HM-4FM/169-37, BD PYXIS MEDBANK TWR MN 2HH-4HM-4FF/169-36, BD PYXIS MEDBANK TWR MN 2HH-2FM-4FF/169-35, BD PYXIS MEDBANK TWR MN 2HH-2FH-4FM/169-34, BD PYXIS MEDBANK TWR MN 2HH-1FH-5FM/169-33, BD PYXIS MEDBANK TWR MN 2HH-10HM-1FM/169-32, BD PY — Reason: Reports of delayed access to medication in automated dispensing cabinets because of the override/Add Item workflow. — Status: Ongoing
FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use with the FilmArray 2.0 system. — Reason: FilmArray NGDS Warrior Panel (NGDS-ASY-0007) has an increased risk of internal control failures when testing positive blood culture, which may lead to delayed results and additional diagnostic workup. — Status: Ongoing
Micro 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
IDM-ARLITE-R. 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
All-round Joystick R-net Light. 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
IDM-MULTI-R. 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
Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860 — Reason: Access Thyroglobulin reagent lot 439163 may generate erroneously high patient results. Falsely increased Access Thyroglobulin results may lead a physician to pursue unnecessary diagnostic imaging studies and/or inappropriate therapy adjustments in patients being monitored for residual or recurrent thyroid cancer. — Status: Ongoing
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