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19,264 catalysts · 4,728 grant · 3,603 8k filing · 2,674 approval · 2,394 device 510k · 1,898 device recall · 1,679 device pma
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19,264 catalysts · 4,728 grant · 3,603 8k filing · 2,674 approval · 2,394 device 510k · 1,898 device recall · 1,679 device pma
TW grant. $171,004. PI: Shristi Rawal
DA grant. $1,153,945. PI: FREDERICK Gerard MOELLER
AG grant. $3,280,861. PI: Kjetil Bjornevik
MH grant. $175,017. PI: Jason William Griffin
AG grant. $2,465,320. PI: Sydney Yoshie Schaefer
AG grant. $506,198. PI: Zhaoqing Ding
TW grant. $2,322. PI: SABRINA MARIE ASTURIAS
TW grant. $63,180. PI: Sarah E Rothenberg
GM grant. $75,520. PI: David Miyamoto
AI grant. $50,698. PI: Sophia Siu
HL grant. $370,096. PI: ANDREA Bridget KELLY
AG grant. $443,875. PI: Abigail Winston Batchelder
CA grant. $354,828
HL grant. $1,214,646
HL grant. $370,373
CA grant. $2,510,508. PI: lynn briscoe
CA grant. $794,843. PI: lynn briscoe
CA grant. $219,752. PI: lynn briscoe
CA grant. $355,000
EY grant. $400,601. PI: Gabriel Kreiman
HL grant. $1,122,619
Sponsor: MANKIND PHARMA. Form: TABLET. Route: ORAL
Sponsor: STRIDES PHARMA. Form: TABLET. Route: ORAL
Sponsor: PFIZER INC. Form: INJECTABLE. Route: SUBCUTANEOUS
Sponsor: BIOCON BIOLOGICS INC. Form: INJECTABLE. Route: INJECTION
Product code: NHA. Advisory committee: Dental. Type: Traditional
Product code: LHI. Advisory committee: General Hospital. Type: Traditional
Product code: JAA. Advisory committee: Radiology. Type: Traditional
Product code: MSS. Advisory committee: Ophthalmic. Type: Traditional
Supplement type: 30-Day Notice. Product code: NIK. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: OZA. Advisory committee: MI. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: PRC. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NVN. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWP. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NIK. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NVN. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: ONU. Advisory committee: CV. Decision: OK30
SuRgical Planner (SRP), software version SRP.7.12.0, imaging processing radiological system — Reason: A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer. — Status: Ongoing
Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented reality — Reason: A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer. — Status: Ongoing
Endo Surgical Navigation Advanced Platform Patient Engagement (EndoSNAP), software version SNP.1.12.0, imaging processing radiological system — Reason: A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer. — Status: Ongoing
SpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SPR.1.2.0, orthopedic augmented reality — Reason: A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer. — Status: Ongoing
Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connect for ECP, Product Code: 1000432. 2. Dbl optical, AIC Impella Connect, Phg US, Product Code: 1000201. 3. Impella Controller, Packaged, AU, Product Code: 0042-0000-AU. 4. Impella Controller, Packaged, CA, Product Code: 0042-0000-CA. 5. Impella Controller, Packaged, EU, Product Code: 0042-0000-EU. 6. Impella Controller, Packaged, IN, Product Code: 0042-0000-IN. 7. Impella Controller, Packaged, JP, Product Code: 0042-0000-JP. 8. Impella Controller, Packaged, UK, Product Code: 0042-0000-UK. 9. Impella Controller, Packaged, US, Product Code: 0042-0000-US. 10. Impella Optical Controller, Packaged, AU, Product Code: 0042-0010-AU. 11. Impella Optical Controller, Packaged, EU, Product Code: 0042-0010-EU. 12. Impella Optical Controller, Packaged, IN, Product Code: 0042-0010-IN. 13. Impella Optical Controller, Packaged, UK, Product Code: 0042-0010-UK. 14. Impella Optical Controller, Packaged, US, Product Code: 0042-0010-US. 15. Optical AIC w/Impella Connect, Pkgd, JP, Product Codes: 0042-0040-JP. 16. Optical AIC w/Impella Connect, Pkgd, JP, Product Codes: 0042-0040-JP-L. 17. Optical AIC w/Impella Connect, Pack'd, CA, Product Code: 0042-0040-CA. 18. Optical AIC w/Impella Connect, Pack'd, EU, Product Code: 0042-0040-EU. 19. Optical, AIC, Impella Connect, Pkgd, AU, Product Code: 0042-0040-AU. 20. Optical, AIC, Impella Connect, Pkgd, UK, Product Code: 0042-0040-UK. 21. Optical, AIC, Impella Connect, Pkgd, US, Product Code: 0042-0040-US. — Reason: Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures. — Status: Ongoing
Surgical Navigation Advanced Platform (SNAP), software version SNP.3.12.0, imaging processing radiological system — Reason: A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer. — Status: Ongoing
Surgical Navigation Advanced Platform Patient Engagement (PE SNAP), software version SNP.3.12.0, imaging processing radiological system — Reason: A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer. — Status: Ongoing