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18,872 catalysts · 4,728 grant · 3,422 8k filing · 2,667 approval · 2,309 device 510k · 1,852 device recall · 1,612 device pma
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18,872 catalysts · 4,728 grant · 3,422 8k filing · 2,667 approval · 2,309 device 510k · 1,852 device recall · 1,612 device pma
LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533 — Reason: The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinical decisions impacting overall care. — Status: Ongoing
PERIFIX FX Continuous Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Open tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFS. Product Description: CE17TKFS EPIDURAL TRAY. — Reason: Potential for the lid of the catheter connector to be in the incorrect position. — Status: Ongoing
Design Options, Pain Management Tray. Product Code: SESK. Product Descriptions: 1. SESK PARKLAND MEMORIAL FX CSE TRAY. 2. SESK OWENSBORO DAVIESS HOSP 20058814. 3. SESK MEMORIAL HEALTH SYSTEM SPINAL/EPID. 4. SESK ST. JOHN'S MERCY MED CTR SPINAL/EPID. 5. SESK MAIMONIDES HOSPITAL SPINAL/EPIDURAL. 6. SESK OU MEDICAL CENTER - SPINAL/EPIDURAL. 7. SESK ELLIS HOSPITAL - SPINAL EPIDURAL. 8. STONY BROOK HSP SPINAL EPIDRAL TRAY SESK. 9. SESK UAB SPINAL EPIDURAL. 10. SESK CREIGHTON UNIV BMH SOINAL EPIDURAL. 11. SESK, BSW SPINAL EPIDURAL TRAY. 12. LYNDON B JOHNSON HOSPITAL SPINAL EPID. — Reason: Potential for the lid of the catheter connector to be in the incorrect position. — Status: Ongoing
Salem Sump PVC Tubes: Product Code/Product Name: 8888264911E ENFit" SALEM SUMP" PVC TUBE 10FR 36IN 8888264929E ENFit" SALEM SUMP" PVC TUBE 12FR 48IN 8888264945E ENFit" SALEM SUMP" PVC TUBE 14FR 48IN 8888264960E ENFit" Salem Sump" PVC Tube 16Fr 48IN 8888264986E ENFit" SALEM SUMP" PVC TUBE 18FR 48IN 8888266106E PVC SALEM SUMP WITH ENFIT & ARV 10FR 36IN 8888266114E PVC SALEM SUMP WITH ENFIT & ARV 12FR 48IN 8888266122E PVC SALEM SUMP WITH ENFIT & ARV 14FR 48IN 8888266130E PVC SALEM SUMP WITH ENFIT & ARV 16FR 48IN 8888266148E PVC SALEM SUMP WITH ENFIT & ARV 18FR 48IN 8888268060E ENFit" SALEM SUMP" PVC TUBE 6FR 24IN 8888268086E ENFit" Salem Sump" PVC Tube 8Fr 24IN — Reason: Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214. — Status: Ongoing
PERIFIX FX Continuous Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Closed tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFCS. Product Description: CE17TKFCS CONT EPID TRAY W/17G TUOHY-LF. — Reason: Potential for the lid of the catheter connector to be in the incorrect position. — Status: Ongoing
PERIFIX FX Continuous Epidural Anesthesia Tray, 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Fixed Wings, 19 Ga. Open tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFSDT. Product Description: CE17TKFSDT EPID TRAY W/17GA FIXED WING. — Reason: Potential for the lid of the catheter connector to be in the incorrect position. — Status: Ongoing
LOGIQ P10 series with software version R4.5.7 Model Number 5877534 — Reason: The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinical decisions impacting overall care. — Status: Ongoing
PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Open tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKF. Product Description: CE17TKF PERIFIX CONTIN. EPIDURAL TRAY — Reason: Potential for the lid of the catheter connector to be in the incorrect position. — Status: Ongoing
HeartSine Pad-Pak, REF: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07, PAD-PAK-03J, PAD-PAK-04J — Reason: Due to customer complaints, defibrillator pads may contain damage pins that disrupt the mechanical fit and electrical contact. — Status: Ongoing
PERIFIX FX Continuous Epidural Anesthesia Set, PERIFIX Tuohy Epidural Needle - 17 Ga. x 3-1/2 in. (8.9 cm) - Winged, PERIFIX FX Springwound Epidural Catheter - 19 Ga. Closed tip. Product Code: CE17TFC. Product Description: CE17TFC CONTINUOUS EPID SET W/17G TUOHY. — Reason: Potential for the lid of the catheter connector to be in the incorrect position. — Status: Ongoing
Salem Sump PVC Tubes: Product Code/Product Name: 266122 Salem Sump" Stomach Tube, Dual Lumen with Anti-Reflux Valve, 14 Fr/Ch (4.7 mm) 266130 Salem Sump" Stomach Tube, Dual Lumen with Anti-Reflux Valve, 16 Fr/Ch (5.3 mm) 266148 Salem Sump" Stomach Tube, Dual Lumen with Anti-Reflux Valve, 18 Fr/Ch 8888266106 Salem Sump" Dual Lumen Stomach Tube, Anti-Reflux Valve 10Fr/Ch (3.3 mm), 36" 266130CN Salem Sump" Tube 16FR with CONFIRM NOW, Nonsterile 266148CN Salem Sump" Tube 8 FR with CONFIRM NOW, Nonsterile — Reason: Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214. — Status: Ongoing
MH grant. $433,125. PI: Quan Lin
CA grant. $194,787. PI: Matthew James Jennings
CA grant. $400,000. PI: Yu-Tsueng Liu
AI grant. $147,290. PI: FOUSSEYNI KANE
OD grant. $1,416,375. PI: Gregory A. Newby
HD grant. $589,099. PI: KIMBERLY M. HUBER
CA grant. $1,296,385. PI: Ashok Gowda
CA grant. $398,039. PI: David Zaharoff
DK grant. $2,287,046. PI: Badih Joseph Elmunzer
HL grant. $169,992. PI: Catherine G Derington
AR grant. $448,278. PI: Christopher Ryan Heier
AA grant. $733,137. PI: Carolina Luisa Haass-Koffler
AG grant. $50,000. PI: Stephanie Anne-Carine Debette
AI grant. $648,576. PI: Adithya Cattamanchi
AG grant. $628,753. PI: Fiona C Baker
HL grant. $1,098,640. PI: Renee Manworren
HD grant. $579,102. PI: LARA A. RAY
DA grant. $19,600
HL grant. $813,284. PI: Loren Elisa Smith
AI grant. $644,759. PI: Justin Jang Hann Chu
MH grant. $958,076. PI: KAREN ELIZABETH BEARSS
CA grant. $994,810. PI: Ian Horvath
CA grant. $392,695. PI: Traci Lyons
DC grant. $54,538. PI: Kirby Tso Leo
CA grant. $360,442. PI: Tao Wang
AI grant. $164,160. PI: Justin Jang Hann Chu
DK grant. $64,289. PI: Josep Maria Mercader
AI grant. $224,943. PI: Mary Sloan Siegrist
AI grant. $587,885. PI: Chad Petit
DC grant. $600,000. PI: Mariah Morton-Jones
AI grant. $1,286,549. PI: Anthony Joseph Garcia-Prats
DC grant. $468,199. PI: Katherine Lindsey Marks
AI grant. $75,520. PI: Timothy Precord
HL grant. $87,964. PI: Nathan Nowalk
MD grant. $1,051,406. PI: Julie Lundstrom
AI grant. $314,363. PI: Zachary N Warnken
AR grant. $297,327. PI: Yanmei Qi
DA grant. $2,250
DA grant. $21,500