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13,713 catalysts · 3,402 8k filing · 2,401 grant · 2,188 approval · 1,517 device 510k · 1,123 device recall · 1,026 device pma
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13,713 catalysts · 3,402 8k filing · 2,401 grant · 2,188 approval · 1,517 device 510k · 1,123 device recall · 1,026 device pma
CA grant. $75,520. PI: Nicole Mihalik
AG grant. $51,038. PI: Siling Du
AI grant. $91,297. PI: Joseph J Eron
AI grant. $264,444. PI: Kiat Ruxrungtham
AI grant. $1. PI: Dan H. Barouch
AI grant. $1. PI: Dan H. Barouch
AI grant. $1. PI: Dan H. Barouch
AI grant. $90,688. PI: Joseph J Eron
AI grant. $288,709. PI: Joseph J Eron
AI grant. $1. PI: Joseph J Eron
AI grant. $105,412. PI: Joseph J Eron
AI grant. $75,000. PI: Alberto La Rosa
CA grant. $350,599. PI: Shanshan Jiang
AI grant. $110,922. PI: David Guy Kirsch
GM grant. $189,459. PI: Konstantinos Sousounis
HL grant. $78,040. PI: Megan Aumann
AA grant. $75,520. PI: Christopher D Walker
CA grant. $41,876. PI: Molly Guthrie
NS grant. $44,020. PI: Henry Kyoung
DK grant. $42,418. PI: Morgan Harwood
DC grant. $46,145. PI: Hannah McCalmon
DC grant. $38,922. PI: Alyssa Luz-Ricca
CA grant. $406,351. PI: Patrick Bhola
AI grant. $35,137. PI: Joseph J Eron
AG grant. $45,294. PI: Robyn Jo McCartan
EB grant. $74,632. PI: Calder Sheagren
AI grant. $193,508. PI: Joseph J Eron
EY grant. $83,224. PI: Andrew Howard Miller
CA grant. $691,400. PI: Erin Lynn Van Blarigan
HL grant. $145,044. PI: Brian T. Palmisano
Sponsor: ELITE LABS INC. Form: TABLET. Route: ORAL
Sponsor: BEIGENE. Form: INJECTION. Route: SOLUTION
Sponsor: TORRENT PHARMS LTD. Form: TABLET. Route: ORAL
Sponsor: LOXO ONCOL. Form: TABLET. Route: ORAL
Sponsor: NANJING KING FRIEND. Form: INJECTABLE. Route: INJECTION
Sponsor: KNACK. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: SANDOZ. Form: TABLET. Route: ORAL
Product code: NGT. Advisory committee: General Hospital. Type: Traditional
Product code: NAY. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: FBK. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: SGT. Advisory committee: Physical Medicine. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Supplement type: 30-Day Notice. Product code: PNJ. Advisory committee: CV. Decision: OK30
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509420 Software Version: N/A Product Description: Affixus 9 mm, Length 420 mm, Right, Trochanteric Nail Component: N/A — Reason: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention. — Status: Ongoing
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509380 Software Version: N/A Product Description: Affixus 9 mm, Length 380 mm, Right, Trochanteric Nail Component: N/A — Reason: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention. — Status: Ongoing
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609320 Software Version: N/A Product Description: Affixus 9 mm, Length 320 mm, Left, Trochanteric Nail Component: N/A — Reason: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention. — Status: Ongoing
KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P — Reason: Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428. — Status: Ongoing
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509340 Software Version: N/A Product Description: Affixus 9 mm, Length 340 mm, Right, Trochanteric Nail Component: N/A — Reason: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention. — Status: Ongoing
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815809280 Software Version: N/A Product Description: Affixus 9 mm, Length 280 mm, Left, Priformis Nail Component: N/A — Reason: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention. — Status: Ongoing
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609300 Software Version: N/A Product Description: Affixus 9 mm, Length 300 mm, Left, Trochanteric Nail Component: N/A — Reason: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention. — Status: Ongoing