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12,251 catalysts · 3,603 8k filing · 2,283 grant · 1,771 approval · 1,164 device 510k · 1,000 device adverse event · 848 device pma
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12,251 catalysts · 3,603 8k filing · 2,283 grant · 1,771 approval · 1,164 device 510k · 1,000 device adverse event · 848 device pma
Medline medical convenience kits packaged as: 1) CANCER SERVICE PORT KIT, Kit SKU DT22710; 2) LINE KIT, Kit SKU DYNDA1857A; 3) PICC REMOVAL KIT, Kit SKU DYNDC1978A; 4) PORT ACCESS TRAY, Kit SKU DYNDC2367; 5) NICU CENTRAL LINE TRAY, Kit SKU DYNDC2407B; 6) CVC DRESSING CHANGE W/ TEG CHG, Kit SKU DYNDC3222A; 7) PICC PROCEDURE PACK, Kit SKU DYNJ59067A; 8) PICC PROCEDURE PACK, Kit SKU PHS950205004B. — Reason: Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators. — Status: Ongoing
1) UNIVERSAL KIT, Kit SKU DT22010B; 2) VAD ACCESS KIT, Kit SKU DT22790C; 3) VAD ACCESS KIT, Kit SKU DT22790C; 4) PROCEDURE TRAY, Kit SKU DYNDA2966A; 5) PROCEDURE TRAY, Kit SKU DYNDA2966A; 6) PEDIATRIC CENTRAL LINE SMALL, Kit SKU DYNDC2208C; 7) PORT DRESSING KIT, Kit SKU DYNDC3107; 8) NON STERILE DIALYSIS KIT, Kit SKU DYNDH1029C; 9) UMBILICAL TRAY W/3.5&5FR CATH, Kit SKU UVT1250; 10) UMBILICAL VESSEL TRAY, Kit SKU UVT835; 11) HEMODIALYSIS TRAY, Kit SKU VAR101HVAA. — Reason: Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators. — Status: Ongoing
Medline medical convenience kits packaged as: BLOOD CULTURE KIT NS, Kit SKU DYNDH2088 — Reason: Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators. — Status: Ongoing
Medline medical convenience kits packaged as: ADULT CATH SECUREMENT DRSG, Kit SKU DYNDC3109 — Reason: Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators. — Status: Ongoing
Medline medical convenience kits packaged as: MERCY CIRCUMCISION TRAY, Kit SKU CIT6135B — Reason: Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators. — Status: Ongoing
Chest Drainage Units and Accessories: Product Code Description 1. 8888571562 Cardinal Health Sentinel Seal CDU 2. 8888571513 Cardinal Health Sentinel Seal CDU, Dual Drain 3. 8888571489 Cardinal Health Sentinel Seal CDU, with Easy Change Connector 4. 8888571370 Cardinal Health Altitude CDU, Dry Suction, with Easy Change Connector 5. 8888571299 Cardinal Health Aqua-Seal CDU, Wet Suction 6. 8888571406 Cardinal Health Aqua-Seal CDU, Wet Suction, Dual Drain 7. 8888571315 Cardinal Health Aqua-Seal CDU, Wet Suction, with Easy Change Connector 8. 8884713100 Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL 9. 1814713105 OUS¿Only - Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL (Bottle only) 10. 1180571570 OUS¿Only - Cardinal Health Thora-Seal CDU, Two Chamber System, 2600 mL 11. 8884713308 Cardinal Health Thora-Seal CDU, Three Chamber System, 2500 mL 12. 8884713900 Cardinal Health Thora-Seal Replacement Collection Chamber, 2500 mL — Reason: The firm is updating the IFU to clarify the intended patient population for the identified chest drainage units and accessories as adults, 18 years and older. When used on infants, the CDU may not demonstrate tidaling/bubbling, which may confound the clinician's assessment of device functionality and lead to inadequate/inappropriate treatment/therapy, delay to treatment/therapy, and prolonged hospitalization. — Status: Ongoing
Feminine hygiene products, labeled as: KOTEX FREEDOM MAXI NO WINGS 48CT, ALWAYS THIN LINERS UNSCENTED 12 CT, ALWAYS THIN LINERS SCENTED 12CT, ALWAYS ULT.THIN WINGS REG.12/22CT, ALWAYS ULT.THIN OVER NIGHT WINGS 12/16CT, JULIE MAXI NIGHT W.WINGS 36/10CT, STAY FREE REG. 12/10CT, STAY FREE SUPER 24/6CT, TAMPAX REG. 10CT, TAMPAX SUPER 10CT. — Reason: Potential exposure of rodents and rodent activity in the distribution center. — Status: Ongoing
Toothbrushes, labeled as: ORAL B TOOTH BRUSH SHINY CLEAN SOFT 12CT; COLGATE TOOTH BRUSH MED. 12CT; ADULT TOOTHPASTE W BRUSH (WHITENING) 6.4oz/24ct; ADULT TOOTHPASTE W BRUSH (ANTICAV) 6.4oz/24ct. — Reason: Potential exposure of rodents and rodent activity in the distribution center. — Status: Ongoing
Condoms, labeled as: TROJAN MAGNUM CONDOMS 6/DSP BLACK, TROJAN LUBRICATED CONDOMS 6/DSP LITE BLUE, TROJAN SPERMICIDE CONDOMS 6/DSP DARK BLUE, TROJAN ULTRA THIN CONDOMS 6/DSP GREY, TROJAN RIBBED CONDOMS 6/DSP GOLD/BROWN, TROJAN NONLUBRICATED CONDOMS 6/DSP RED, TROJAN ULTRA HER PLEASURE CONDOMS 6/DSP, TROJAN CONDOMS MAGNUM 48 CT DISP, *BOX TROJAN CONDOMS MAGNUM 50CT . — Reason: Potential exposure of rodents and rodent activity in the distribution center. — Status: Ongoing
PREGNANCY TEST 24CT — Reason: Potential exposure of rodents and rodent activity in the distribution center. — Status: Ongoing
Bandages and first aid kits: FIRST AID KIT 24/42PC, LUCKY FIRST AID BANDAGES 24CT — Reason: Potential exposure of rodents and rodent activity in the distribution center. — Status: Ongoing
Sponsor: SUN PHARM INDUSTRIES. Form: TABLET. Route: ORAL
Sponsor: TEVA. Form: TABLET. Route: ORAL
Sponsor: CHARTWELL RX. Form: TABLET. Route: ORAL
Sponsor: PHARMOBEDIENT. Form: SYRUP. Route: ORAL
Sponsor: INVAGEN PHARMS. Form: CAPSULE. Route: ORAL
Sponsor: CSPC OUYI PHARM CO. Form: TABLET. Route: ORAL
Sponsor: WES PHARMA INC. Form: TABLET. Route: ORAL
Sponsor: HIBROW HLTHCARE. Form: SOLUTION. Route: ORAL
Sponsor: OZANTRI. Form: TABLET. Route: ORAL
Sponsor: AUROBINDO PHARMA. Form: TABLET. Route: ORAL
Sponsor: AUROBINDO PHARMA. Form: CAPSULE. Route: ORAL
Sponsor: AUROBINDO PHARMA LTD. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: MACLEODS PHARMS LTD. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: MACLEODS PHARMS LTD. Form: TABLET. Route: ORAL
Sponsor: SUN PHARM. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: MACLEODS PHARMS LTD. Form: TABLET. Route: ORAL
Sponsor: LUPIN LTD. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: WATSON LABS INC. Form: TABLET. Route: ORAL
Sponsor: GRAVITI PHARMS. Form: TABLET. Route: ORAL
Sponsor: AMNEAL PHARMS. Form: TABLET. Route: ORAL
Sponsor: COSETTE. Form: SYRUP. Route: ORAL
Sponsor: IPCA LABS LTD. Form: TABLET. Route: ORAL
Sponsor: PH HEALTH. Form: INJECTABLE. Route: INJECTION
Sponsor: PH HEALTH. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: HETERO LABS LTD V. Form: CAPSULE. Route: ORAL
Sponsor: AUROBINDO PHARMA LTD. Form: TABLET. Route: ORAL
Sponsor: SUN PHARM. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: IMPAX LABS. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: MPP PHARMA. Form: TABLET. Route: ORAL
Sponsor: ALKEM LABS LTD. Form: TABLET. Route: ORAL
Sponsor: SPECGX LLC. Form: TABLET. Route: ORAL
Sponsor: SPECGX LLC. Form: TABLET. Route: ORAL
Sponsor: GLAND. Form: INJECTABLE. Route: INJECTION
Product code: CAW. Advisory committee: Anesthesiology. Type: Traditional
Product code: FGE. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: OHT. Advisory committee: General, Plastic Surgery. Type: Special
Product code: HTY. Advisory committee: Orthopedic. Type: Traditional
Product code: PNN. Advisory committee: Dental. Type: Traditional
Product code: JOH. Advisory committee: Anesthesiology. Type: Traditional