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18,800 catalysts · 4,728 grant · 3,350 8k filing · 2,667 approval · 2,309 device 510k · 1,852 device recall · 1,612 device pma
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18,800 catalysts · 4,728 grant · 3,350 8k filing · 2,667 approval · 2,309 device 510k · 1,852 device recall · 1,612 device pma
HG grant. $3,349,527. PI: Anne O'Donnell-Luria
DE grant. $716,123. PI: CHRISTINE H CHUNG
CA grant. $1,549,462. PI: Timothy William Mullett
AG grant. $77,752. PI: Julianne Clina
DC grant. $75,052. PI: Melissa C Franch
GM grant. $2,313,209. PI: Sathish K Ramakrishnan
DK grant. $759,135. PI: Lily Dara
HL grant. $37,289. PI: Elizabeth Mariya Engle
GM grant. $361,283. PI: Roy Rabinu Lederman
ES grant. $631,279. PI: Ellen Joan Bluth
CA grant. $197,518. PI: Theodore Willis Laetsch
NS grant. $302,782. PI: Sherif M Elbasiouny
CA grant. $703,321. PI: Erin Elizabeth Hahn
HD grant. $2,416,587. PI: Sharon Dekel
DK grant. $315,747. PI: Yan sHI Zhao
CA grant. $406,500. PI: Kenneth Schultz
DK grant. $178,026. PI: Justin Xavier Boeckman
HL grant. $1,266,937. PI: Matthew Dominic Bacchetta
NR grant. $3,399,035. PI: LORETTA DIPIETRO
GM grant. $543,750. PI: Christopher L Colbert
Sponsor: HORIZON THERAPEUTICS IRELAND. Form: INJECTABLE. Route: INJECTION
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: LOL. Advisory committee: Microbiology. Type: Traditional
Product code: FIP. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: KPO. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: LNH. Advisory committee: Radiology. Type: Traditional
Product code: ONN. Advisory committee: Neurology. Type: Special
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: KPS. Advisory committee: Radiology. Type: Special
Product code: LCX. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: DSB. Advisory committee: Cardiovascular. Type: Traditional
Product code: NUC. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Supplement type: 30-Day Notice. Product code: NJL. Advisory committee: OR. Decision: OK30
Supplement type: 30-Day Notice. Product code: QZK. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MGR. Advisory committee: SU. Decision: OK30
Supplement type: 30-Day Notice. Product code: LMG. Advisory committee: SU. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: NIK. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: NKM. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MIH. Advisory committee: CV. Decision: OK30
Product code: MCN. Advisory committee: OB. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: LWS. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: MIH. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MIH. Advisory committee: CV. Decision: OK30
NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I — Reason: Fluctuations may be more likely to occur if the total flow through the device sensor (used by the device to determine flow) is less than the minimum device requirement of 0.5 LPM. In addition, dose fluctuations have been observed when Bunnel LifePulse HFJV system or conventional ventilators have the following device settings: low service pressures generally less than 3.0 PSI, a pressure difference greater than 5.0cm H2O; or at breath per minute rates of 300 (5 Hz). — Status: Ongoing
Ashvins variant HEYEX 2 / HEYEX PACS. Software Version: Version 2.6.0 (Build 2088) to 2.6.8 (Build 2220). Device Type: Software (Medical Image Management, Picture Archiving and Communication System) — Reason: Potential that the measured value may be smaller than the actual area. — Status: Ongoing
Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Product Description: The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates. The device can be used for mechanical ventilation, manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing. The device is specified for inhalational anesthesia and/or patient ventilation in accordance with the intended use during surgical or diagnostic interventions Component: Not applicable — Reason: The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use. — Status: Ongoing
BioPro Bipolar Head Product ID/Description 18130 BIPOLAR HEAD 38MM 18131 BIPOLAR HEAD 39MM 18132 BIPOLAR HEAD 40MM 18133 BIPOLAR HEAD 41MM 18134 BIPOLAR HEAD 42MM 18135 BIPOLAR HEAD 43MM 18136 BIPOLAR HEAD 44MM 18137 BIPOLAR HEAD 45MM 18138 BIPOLAR HEAD 46MM 18139 BIPOLAR HEAD 47MM 18140 BIPOLAR HEAD 48MM 18141 BIPOLAR HEAD 49MM 18142 BIPOLAR HEAD 50MM 18143 BIPOLAR HEAD 51MM 18144 BIPOLAR HEAD 52MM 18145 BIPOLAR HEAD 53MM 18146 BIPOLAR HEAD 54MM 18147 BIPOLAR HEAD 55MM 18148 BIPOLAR HEAD 56MM 18149 BIPOLAR HEAD 57MM 18150 BIPOLAR HEAD 58MM 18151 BIPOLAR HEAD 59MM 18152 BIPOLAR HEAD 60MM — Reason: Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted. — Status: Ongoing
BioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic heads Part ID/Description: 18593 HEAD FEMORAL 22MM -3 18594 HEAD FEMORAL 22MM +0 19003 HEAD FEMORAL 28MM-6 19004 HEAD FEMORAL 28MM-3 19005 HEAD FEMORAL 28MM+0 19006 HEAD FEMORAL 28MM+3 19007 HEAD FEMORAL 28MM+6 19008 HEAD FEMORAL 28MM+9 19053 HEAD FEMORAL 36MM -3 19054 HEAD FEMORAL 36MM +0 19055 HEAD FEMORAL 36MM +3 19056 HEAD FEMORAL 36MM +6 19057 HEAD FEMORAL 36MM +9 19130 HEAD FEMORAL 32MM-6 19131 HEAD FEMORAL 32MM-3 19132 HEAD FEMORAL 32MM+0 19133 HEAD FEMORAL 32MM +3 19134 HEAD FEMORAL 32MM+6 19135 HEAD FEMORAL 32MM +9 — Reason: Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted. — Status: Ongoing