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20,381 catalysts · 4,728 grant · 3,622 8k filing · 2,895 device 510k · 2,752 approval · 2,000 device pma · 2,000 device recall
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20,381 catalysts · 4,728 grant · 3,622 8k filing · 2,895 device 510k · 2,752 approval · 2,000 device pma · 2,000 device recall
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
Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 92810 Software Version: 11.6.0 Product Description: Cardiology Information Management System Component: No The Sentinel Cardiology Information Management System is intended to connect to supported medical devices and analyzers in order to download, store, access and manage cardiovascular information and to manage patient and facility information. — Reason: Due to two distinct issues: 1. During patient admission, patient demographic fields may default to those of a previously viewed patient. 2. Systems configured with Resting/Rhythm ECG functionality, under specific navigation conditions, test data intended for one patient may be saved under another patient's record — Status: Ongoing
SyncAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), 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