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15,048 catalysts · 3,603 8k filing · 2,723 grant · 2,426 approval · 1,714 device 510k · 1,264 device recall · 1,172 device pma
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15,048 catalysts · 3,603 8k filing · 2,723 grant · 2,426 approval · 1,714 device 510k · 1,264 device recall · 1,172 device pma
Product code: HTN. Advisory committee: Orthopedic. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: QEW. Advisory committee: Cardiovascular. Type: Special
Product code: DQY. Advisory committee: Cardiovascular. Type: Traditional
Product code: KWS. Advisory committee: Orthopedic. Type: Traditional
Product code: HQF. Advisory committee: Ophthalmic. Type: Traditional
Product code: LRK. Advisory committee: Dental. Type: Special
Product code: KRH. Advisory committee: Cardiovascular. Type: Special
Product code: PGY. Advisory committee: Radiology. Type: Special
Product code: HGX. Advisory committee: Obstetrics/Gynecology. Type: Special
Product code: MBI. Advisory committee: Orthopedic. Type: Traditional
Product code: JWH. Advisory committee: Orthopedic. Type: Special
Product code: MMI. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: QAI. Advisory committee: General, Plastic Surgery. Type: Special
Product code: GCJ. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: PHX. Advisory committee: Orthopedic. Type: Special
Product code: JDW. Advisory committee: Orthopedic. Type: Traditional
Product code: NFO. Advisory committee: Neurology. Type: Traditional
Supplement type: 30-Day Notice. Product code: QWK. Advisory committee: OR. Decision: OK30
Supplement type: 30-Day Notice. Product code: NIQ. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: MJO. Advisory committee: OR. Decision: APPR
Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MWG. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NWX. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NVY. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: QSK. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: MJO. Advisory committee: OR. Decision: APPR
Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. Y-TYPE BLOOD SET W/ 170 ?M FILTER 120 IN; Catalog Number: 490355. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DROPS/ML 126 IN; Catalog Number: 490283. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing
Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. Y-TYPE BLOOD SET 124 IN.; Catalog Number: 490196. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing
SafeDAY set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADM SET 15 DR W/2 SAFEDAY & STOPCOCK; Catalog Number: 352646. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN 15D, 2 B/C VLV, 3 CARESITE LADS; Catalog Number: 490653. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing
Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DROPS/ML, 132 IN; Catalog Number: 490469. 2. IV ADMIN SET, 60D 2 CARESITE VLV, 132 IN; Catalog Number: 490470. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing
Infusomat utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog numbers: 1. UNIV.15DROP PUMP SET W/3 SAFELINE LL; 15 drops/mL, priming volume: 22mL, length: 119in, SafeLine; Catalog Number: 362032. 2. UNIV. 15 DR PUMP SET, 1.2 FIL, 2 CRSITE; UNIV. 15 DR PUMP SET, 1.2 FIL, 2 CRSITE; Catalog Number: 362033. 3. 60DROP METRISET PUMP SET, 3 SAFELINE; Priming volume: 19mL, length: 120in, SafeLine; Catalog Number: 362034. 4. Y TYPE BLOOD PUMP SET, SAFELINE INJ; Priming volume: 39mL, length: 120in, SafeLine¿; Catalog Number: 362043. 5. UNIV. 15 DROP PUMP SET W/ 0.2 FILTER; 15 drops/mL, priming volume: 26mL, length: 124in, SafeLine; Catalog Number: 362050. 6. SPACE PUMP SET 15 DROP W/2 SAFEDAY; SPACE PUMP SET 15 DROP W/2 SAFEDAY; Catalog Number: 362420. 7. UNIV. 15 DROP PUMP SET W/ 3 ULTRASITE LL; 15 drops/mL, priming volume: 21mL, length: 120in, ULTRASITE; Catalog Number: 362431. 8. SPACE PUMP IV SET, 120 IN.; 15 drops/mL, priming volume: 21mL, length: 118in, ULTRASITE; Catalog Number: 362432. 9. 60 DROP METRISET PUMP SET,3 SFLINE ASV; Priming volume: 21mL, length: 121in, SafeLine; Catalog Number: 363010. 10. Y-TYPE BLOOD PUMP SET, SAFELINE, ASV; Priming volume: 40mL, length: 123in, SafeLine; Catalog Number: 363019. 11. UNIV. 15 DROP PUMP SET W/3 SAFELINE, ASV; 15 drops/mL, priming volume: 22mL, length: 119in, SafeLine; Catalog Number: 363030. 12. UNIV. 15 DROP PUMP SET, 3 ULTRASITE, ASV; 15 drops/mL, priming volume: 22mL, length: 123in, ULTRASITE; Catalog Number: 363230. 13. Y-TYPE BLOOD PUMP SET, CARESITE, ASV; Priming volume: 41mL, length: 120in, CARESITE; Catalog Number: 363419. 14. SPACE PUMP IV SET, 2 CARESITES, ASV; 15 drops/mL, priming volume: 24mL, length: 120in, CARESITE; Catalog Number: 363420. 15. UNIV. 15 DROP PUMP SET, 2 CARESITE, ASV; 15 drops/mL, priming volume: 22mL, length: 120in, CARESITE; Catalog Number: 363421. 16. 60DROP METRISET PUMP, 3 CARESITES, ASV; Priming volume: 21mL, length: 130in, CARESITE; Catalog Number: 363422. 17. UNIV. 60 DROP PUMP SET, 2 CARESITES, ASV; 60 drops/mL, priming volume: 21mL, length: 118in, CARESITE; Catalog Number: 363423. 18. UNIV. 15 DR PUMP SET, 1.2FIL, 2CRSTE ASV; UNIV. 15 DR PUMP SET, 1.2FIL, 2CRSTE ASV; Catalog Number: 363424. 19. UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV; 15 drops/mL, priming volume: 23mL, length: 123in, CARESITE; Catalog Number: 363430. 20. UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV; UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV; Catalog Number: 363433. 21. SPACE PUMP IV SET 15D, 110 IN.; "SPACE PUMP IV SET 15D, 110 IN. CLOSE"; Catalog Number: 480254. 22. SPACE PUMP IV SET, 127 IN.; SPACE PUMP IV SET, 127 IN.; Catalog Number: 480255. 23. SPACE PUMP SET 15D, CARESITE LAD 122 IN. ; 15 drops/mL, priming volume: 23mL, length: 122in, CARESITE; Catalog Number: 480256. 24. 15 DROP PUMP SET 1 SAFEDAY 0.2 FILTER; 15 DROP PUMP SET 1 SAFEDAY 0.2 FILTER; Catalog Number: 480258. 25. SPACE PUMP IV SET 15D, 90 IN.; SPACE PUMP IV SET 15D, 90 IN.; Catalog Number: 480263. 26. UNIV. 15 DROP PUMP SET W 3 CARESITE L.L.; 15 drops/mL, priming volume: 22mL, length: 120in, CARESITE; Catalog Number: 490100. 27. 60 DROP METRISET PUMP SET, 3 CARESITES; Priming volume: 19mL, length: 120in, CARESITE; Catalog Number: 490101. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing
Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. EXT/2INJ/FLBL/FML LRLK/CV 34; Catalog Number: V5405. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. PB1500 15 DROP IV SET W/2 STOPCOCKS; Catalog Number: 490025. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. AESTHESIA IV SET, 127 in.; Catalog Number: 490551. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. Catalog Number: 490549; Primary UDI-DI: 04046955270323; Unit of Dose UDI-DI: 04046955270316; Expiration Date: Earliest Exp of Comp or 36mths. 2. Catalog Number: 490565; Primary UDI-DI: 04046955275601; Unit of Dose UDI-DI: 04046955275595; Expiration Date: Earliest Exp of Comp or 36mths. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV SET 3 CARESITE ULTRA ZERO 2/SWAB SAFE; IV Set With 3 CARESITE Injection Sites, ULTRAPORT Zer0 High-Flow, 4-Way Stopcock, and Dual Port SAFEPORT; Catalog Number: 457515. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMINISTRATION SET, 138 IN.; Catalog Number: 490491. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing
Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. EXTENSION SET W/ B/C VALVE 53 in.; Catalog Number: 490358. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/ B/C VALVE,103 IN.; Catalog Number: 470179. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing
Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog numbers: 1. ANESTHESIA SET W/ SAFEPORT MANIFOLD; Catalog Number: 456521. 2. ANES SET W/TRIPLE LL SAFEPORT MANIFOLD; Catalog Number: 456522. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. NF1505, IV ADMIN SET W/2 H.F. STOPCOCKS; Catalog Number: 490088. 2. IV ADMIN SET W/2 SAFELINE & HF STOPCOCK; Catalog Number: 490107. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing
Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. OUTLOOK IV SET 15DROP W/2 CARESITE; Catalog Number: 354212. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADM 15D 2 CARESITE, SAFEPORT MANIFLD; Catalog Number: 354208. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET 15DR HF 4-WAY STPCK 135 IN.; Catalog Number: 490193. 2. IV AD SET, 2 CARESITE, SAFEPORT, 134 IN.; Catalog Number: 490326. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing
Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174 — Reason: Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant. — Status: Ongoing
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADM 15 DROP W/3 CARESITE N/C DUAL; Catalog Number: 354211. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing
CT 5300; Software Version Number: 4.5, 5.0, 5.1; — Reason: If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This component may become detached and make contact with other components located within the Incisive CT systems during rotation. Other components could be damaged due to the contact with the tube heat exchanger. — Status: Ongoing