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19,746 catalysts · 4,728 grant · 3,189 8k filing · 2,785 device 510k · 2,724 approval · 2,000 device recall · 1,962 device pma
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19,746 catalysts · 4,728 grant · 3,189 8k filing · 2,785 device 510k · 2,724 approval · 2,000 device recall · 1,962 device pma
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16MM, VE Model/Catalog Number: 341-16-704 Product Description: Enovis knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use. While total knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients. — Reason: Knee implants contain incorrect labeling (size and/or side incorrect) — Status: Ongoing
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 7R 16MM, VE Model/Catalog Number: 342-16-707 Product Description: Enovis knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use. While total knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients. — Reason: Knee implants contain incorrect labeling (size and/or side incorrect) — Status: Ongoing
Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult, Catalog Number: 523211000 2 SPUR II Adult Resuscitator w/Mercury Filter, Adult, Catalog Number: 523611051 3 SPUR II Adult Resuscitator, Single Patient Use Resuscitator, Adult, Catalog Number: 523611057 4 SPUR II Adult Resuscitator, Single Patient Use Resuscitator, Adult, Catalog Number: 524611000 5 SPUR II Adult Resuscitator, Pop-off open 40 ,w/PEEP Valve 20, Adult, Catalog Number: 524611001 6 SPUR II Adult Resuscitator w/PEEP Valve 20, Adult, Catalog Number: 524611011 7 SPUR II Adult Resuscitator w/Pressure Limiting Valve, Adult, Catalog Number: 524611031 8 SPUR II Adult Resuscitator w/Pressure Limiting Valve, Adult, Catalog Number: 524611047 9 SPUR II Adult Resuscitator, Single Patient Use Resuscitator, Adult, Catalog Number: 524611051 10 SPUR II Pediatric Resuscitator w/10 O2 tube & Manometer, Catalog Number: 530200016 11 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530212000 12 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530212001 13 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530213000 14 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530213001 15 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530213011 16 SPUR II Pediatric Resuscitator w/Manometer, Pediatric, Catalog Number: 530213030 17 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530213031 18 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530213048 19 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530214000 20 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530613000 21 SPUR II Pediatric Resuscitator w/Manometer & PEEP Valve 20, Pediatric, Catalog Number: 530613031 22 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530613071 23 SPUR II Pediatric Resuscitator w/PEEP Valve 20,Manometer & CO2 Detector, Pediatric, Catalog Number: 530613831 24 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530614017 25 SPUR II Pediatric Resuscitator w/Manometer, Pediatric, Catalog Number: 530614030 26 SPUR II Pediatric Resuscitator w/CO2 Detector, Pediatric, Catalog Number: 530614800 27 SPUR II Pediatric Resuscitator, INF& TOD W/Manometer, Pediatric, Catalog Number: 530615030 28 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530619031 29 SPUR II Pediatric Resuscitator w/Expiratory Filter, Manometer PEEP Valve, Pediatric, Catalog Number: 531600051 30 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 531613000 31 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 531613001 32 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 531613010 33 SPUR¿ II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 531613031 34 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 531613047 35 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number:531613051 36 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 531614026 37 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 531638000 38 SPUR II Adult Resuscitator, Single Patient Use Resuscitator, Adult, Catalog Number: 523611051E 39 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number:530213000B The Ambu SPUR II Resuscitator is a single patient use resuscitator intended for pulmonary resus — Reason: Potential for the manometer port being blocked rendering the manometer non-functional. — Status: Ongoing
Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use with IV tubing. — Reason: Label is incorrect. The product label indicates that the device contains an air eliminating filter. However, the filter utilized on this extension set is not indicated for removal of air and does not feature an air vent, which is common to air eliminating filters. — Status: Ongoing
VITROS Chemistry Products Ca Slides; Catalog Number: 145 0261; — Reason: Generations 67 and above of VITROS Ca Slides are experiencing an increased occurrence of Condition Code TH4-63J during calibration on VITROS XT 3400 and VITROS XT 7600 Systems, causing calibration failures that delay calcium test results and potentially impact patient management. The imaging reflectometer algorithm detects excessive "spikes" (imperfections) in slide images and generates the TH4-63J condition code when the threshold of 600 spikes is exceeded. Updated analysis revealed a 19-fold increase in failure rates from 0.0043% (2024 baseline) to 0.082% for Generation 67+ slides in 2025, with 100% of calibrator failures occurring at the lowest concentration level. This can result in delayed diagnosis and treatment of conditions such as hypercalcemic crisis, parathyroid disorders, and other calcium-related emergencies requiring urgent intervention. — Status: Ongoing
Product code: OWB. Advisory committee: Radiology. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Special
Product code: SBF. Advisory committee: Neurology. Type: Traditional
Product code: HAW. Advisory committee: Neurology. Type: Traditional
Product code: LCD. Advisory committee: Clinical Toxicology. Type: Special
Product code: DZE. Advisory committee: Dental. Type: Traditional
Product code: OUR. Advisory committee: Orthopedic. Type: Traditional
Product code: KRD. Advisory committee: Cardiovascular. Type: Traditional
Product code: LZA. Advisory committee: General Hospital. Type: Traditional
Product code: MHX. Advisory committee: Cardiovascular. Type: Traditional
Sponsor: PFIZER INC. Form: SOLUTION. Route: INJECTION
Supplement type: 30-Day Notice. Product code: SEQ. 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: PRC. Advisory committee: CV. Decision: OK30
Product code: SFA. Advisory committee: OR. Decision: APPR
Supplement type: 30-Day Notice. Product code: NBE. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NIQ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NIO. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: ONU. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NIP. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MAF. Advisory committee: CV. Decision: OK30
IDM-MICRO-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
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