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    Medline convenience kits containing Olympus biopsy valves: 1. BRONCH PACK, DYKE2096 2. NON MB BRONCHOPSCOPY CCH LH PK, DYNJT6182 3. PULMONARY BRONCH PACK, DYNDA2861A

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·April 8, 2026

    Description/REF: PSI KIT: 7 FR X 4 IN/ASK-09701-UP; PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-09803-OSU5; PSI KIT: 8.5 FR/ASK-09807-UC; PSI KIT: 9 FR X 4 1/8IN (10 CM)/ASK-09903-HH2; PSI KIT: 9 FR X 10 CM/ASK-09903-LMDTG; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09903-OSU5; PSI KIT: 9 FR X 10 CM/CDC-09903-1A; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-11242-KSF2; MAC TWO LUMEN/PSI KIT: 9 FR X 11.5 CM/ASK-11242-KSF1 AGB MAC KIT: 2L 9 FR DISTAL/ASK-21242-MCY1; MULTI LUMEN PSI KIT: 9 FR DISTAL X 4 1/2/ASK-21242-OSU4; MAC KIT: 2-L 9 FR DISTAL X 11.5 CM/ASK-21242-UCD1; 2L MAC KIT: 9 FR DISTAL X 4 IN/ASK-21142-HHC MAC KIT: 2L 9 FR DISTAL X 11.5 CM AGB/ASK-21242-LMDT; PSI KIT: 8.5 FR X 4IN (10 CM)/ASK-09804-CCH; PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-29803-MM2; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-29903-DU1; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-29903-HHC; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-LMDT; PSI KIT: 9 FR X 4 1/8 (10 CM)/ASK-29903-NWM; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-SL1; PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/CDC-29803-XCN1A; PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-29803-HF6; PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-29804-HHN1; MULTI LUMEN/MAC KIT: 9 FR X 4 IN (10 CM)/ASK-21142-YWH;

    FDA Enforcement
    Class I ·Ongoing·ARROW INTERNATIONAL, LLC·June 24, 2026

    Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. PLASTICS FREE FLAP, Medline Kit Number/SKU CDS983493N; 2. TLIF PACK, Medline Kit Number/SKU DYNJ02476O; 3. DONOR FREE FLAP PACK-LF, Medline Kit Number/SKU DYNJ0426069N; 4. DONOR FREE FLAP PACK-LF, Medline Kit Number/SKU DYNJ0426069Q; 5. MINOR MB PACK-LF, Medline Kit Number/SKU DYNJ0429303L; 6. ENDOSCOPIC SKULL BASE PACK-LF, Medline Kit Number/SKU DYNJ0753948J; 7. RR-H&N FREEFLAP BLCKWELL PK-LF, Medline Kit Number/SKU DYNJ0785741K; 8. MINIMALLY INVASIVE PACK-LF, Medline Kit Number/SKU DYNJ0843063K; 9. FREE FLAP BASIC SET-UP PK, Medline Kit Number/SKU DYNJ0991320K; 10. FREE FLAP BASIC SET-UP PK, Medline Kit Number/SKU DYNJ0991320M; 11. MLD PACK, Medline Kit Number/SKU DYNJ19521Q; 12. SINUS ENDOSCOPY PACK, Medline Kit Number/SKU DYNJ34623C; 13. PMD PACK SURG CNTR-LF, Medline Kit Number/SKU DYNJ35305G; 14. LARYNGOSCOPY PACK, Medline Kit Number/SKU DYNJ37547D; 15. FUNCTIONAL SINUS ENDOSCOPY, Medline Kit Number/SKU DYNJ40406A; 16. ENDOSCOPY PACK, Medline Kit Number/SKU DYNJ40645C; 17. FREE FLAP B PACK, Medline Kit Number/SKU DYNJ40648G; 18. MINOR ENT PACK, Medline Kit Number/SKU DYNJ50808A; 19. SINUS ENDOSCOPY PACK-LF, Medline Kit Number/SKU DYNJ52062; 20. LAP PACK, Medline Kit Number/SKU DYNJ52116B; 21. LAP PACK, Medline Kit Number/SKU DYNJ52116C; 22. ENDOSCOPY PK, Medline Kit Number/SKU DYNJ54719C; 23. ENDOSCOPY PK, Medline Kit Number/SKU DYNJ54719D; 24. FREE FLAP PACK, Medline Kit Number/SKU DYNJ56917I; 25. FREE FLAP PACK, Medline Kit Number/SKU DYNJ56917J; 26. FREE FLAP PACK, Medline Kit Number/SKU DYNJ56917K; 27. FREE FLAP PACK, Medline Kit Number/SKU DYNJ56917L; 28. FREE FLAP PACK, Medline Kit Number/SKU DYNJ56917N; 29. LARYNGOSCOPY WEST PACK, Medline Kit Number/SKU DYNJ58324A; 30. CCH DECOMPRESSION PACK, Medline Kit Number/SKU DYNJ67558A; 31. CCH DECOMPRESSION PACK, Medline Kit Number/SKU DYNJ67558B; 32. FREE FLAP PACK, Medline Kit Number/SKU DYNJ68213; 33. FREE FLAP PACK, Medline Kit Number/SKU DYNJ68213D; 34. FREE FLAP PACK, Medline Kit Number/SKU DYNJ68213G; 35. EENT PACK, Medline Kit Number/SKU DYNJ68366B; 36. FREE FLAP NO DRAPE PACK NTX, Medline Kit Number/SKU DYNJ68447; 37. FREE FLAP NO DRAPE PACK NTX, Medline Kit Number/SKU DYNJ68447A; 38. FREE FLAP NO DRAPE PACK NTX, Medline Kit Number/SKU DYNJ68447B; 39. UNIVERSITY DISC PACK, Medline Kit Number/SKU DYNJ69824; 40. MAJOR PACK, Medline Kit Number/SKU DYNJ81325; 41. MAJOR PACK, Medline Kit Number/SKU DYNJ81325A; 42. MAJOR PACK, Medline Kit Number/SKU DYNJ81325B; 43. PLANO DIEP PACK, Medline Kit Number/SKU DYNJ81751; 44. PLANO DIEP PACK, Medline Kit Number/SKU DYNJ81751A; 45. FLAP PACK, Medline Kit Number/SKU DYNJ85359; 46. ENDO PACK, Medline Kit Number/SKU DYNJ86125; 47. ENDO PACK, Medline Kit Number/SKU DYNJ86125A; 48. ENT PACK, Medline Kit Number/SKU DYNJ88448; 49. MAJOR BACK PACK, Medline Kit Number/SKU DYNJ88470; 50. UROLOGY DAVINCI, Medline Kit Number/SKU DYNJ901572O; 51. LARYNGOSCOPY/BRONCH, Medline Kit Number/SKU DYNJ902985F; 52. KIT FREE FLAP MOSES, Medline Kit Number/SKU DYNJ905366B; 53. FLAP, Medline Kit Number/SKU DYNJ907076C; 54. TRANSPHENOIDAL, Medline Kit Number/SKU DYNJ908165; 55. TRANSPHENOIDAL, Medline Kit Number/SKU DYNJ908165A; 56. ENDOSCOPY, Medline Kit Number/SKU DYNJ909512; 57. DIEP FLAP, Medline Kit Number/SKU DYNJ910120A; 58. DIEP BREAST, Medline Kit Number/SKU DYNJ911086; 59. WILLIAMS GENERAL, Medline Kit Number/SKU DYNJ940735F; 60. ROBOTIC LAP PROSTATE PACK CHS, Medline Kit Number/SKU DYNJT3101; 61. CUH FLAP ACCESSORY PACK, Medline Kit Number/SKU DYNJT3243.

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·May 6, 2026

    The ICS CHARTR EP 200

    FDA Enforcement
    Class II ·Terminated·GN Otometrics·October 30, 2019

    GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5 LITER/4266, distributed by DJO, LLC / DJO FRANCE in the following kits, Part/Description: 2073/ INTELECT RPW 120V, 2073-BR/ INTELECT RPW 120V BRAZIL, 2074/ INTELECT RPW 230 V, 2082/ INTELECT RPW 100 V, 2760/ INTELECT LEGEND XT COMBOUS STD, 2791/ INTELECT LEGEND XT COMBO US STD W/CART, 2782-10/ INTELECT TRANSPORT US STD, 2782-2/ INTELECT TRANSPORT US STD, 2843/ INTELECT VET 4CH COMBO PKG, 2845K/ KIT INTELECT VET 4CH COMBO PKG, 2863/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 5CM, 2863-10/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 10CM APPL, 2863-2/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 2CM APPL, 2864/ SENIOR SOLUTIONS 4CH COMBO PKG US STD, 2761/ VECTRA GENISYS 2CH COMBO PKG US STD 5CM APPL, 2792/ VECTRA GENISYS 2CH COMBO US STD W/CART, 2761-10/ VECTRA GENISYS 2CH COMBO PKG US STD 10CM APPL, 2761-2/ VECTRA GENISYS 2CH COMBO PKG US STD 2CM APPL, 2762CC/ INT ADV 2CH COLOR COMBO INT'L 5CM APPL, 2762CC-10/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 10CM APPL, 2762CC-2/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 2CM APPL, 2788/ LEGEND XT 4CH COMBO PKG US STD 5CM APPL, 2795/ INTELECT XT 4CH COMBO US STD 5CM APPL W/CART, 2788-10/ LEGEND XT 4CH COMBO PKG US STD 10CM APPL, 2795-10/ INTELECT XT4CH COMBO US STD 10CM APPL, 2788-2/ LEGEND XT 4CH COMBO PKG US STD 2CM APPL, 2795-2/ INTELECT XT 4CH COMBO US STD 2CM APPL, 2789/ VECTRA GENISYS 4CH COMBO PKG US 5CM APPL, 2796/ VECTRA GENISYS 4CH COMBO US STD W/CART, 2796K/ KIT VECTRA GENISYS 4CH COMBO P, 2789-10/ VECTRA GENISYS 4CH COMBO PKG US STD 10CM APPL, 2796-10/ VECTRA GENISYS 4CH COMBO US US STD 10CM APPL, 2789-2/ VECTRA GENISYS 4CH COMBO PKG US STD 2CM APPL, 2796-2/ VECTRA GENISYS 4CH COMBO US STD 2CM APPL, 2738/ INTELECT TRANSPORT COMBO PKG US STD, 8250KP/ KIT TRITON DTS PROMO, 6001/ INTELECT NEO, 2738-10/ INTELECT TRANSPORT COMBO PKG US STD, 2738-2/ INTELECT TRANSPORT COMBO PKG US STD, 2772MC/ INT ADVANCED COMBO MONOCHROMEINT'L STD, 2776/ INTELECT MOBILE INT'L STD 5CM APPL, 27800/ ULTRASOUND ON CART, 2776-BR/ INTELECT MOBILE INTL STD 5CM APPL BRAZIL, 2776-10/ INT MOBIL INT'L STD 10CM APPL, 2776-2/ INT MOBILE INT'L STD 2CM APPL, 2778/ INTELECT MOBILE COMBO INT'L STD 5CM APPL, 2778-10/ INTELECT MOBILE COMBO INT'L STD 10CM APPL, 2778-2/ INTELECT MOBILE COMBO INT'L STD 2CM APPL, 2752CC/ INT ADV 2CH COLOR COMBO INT'L STD, 2756/ INTELECT VET 2CH COMBO PKG INT'L STD, 2844K/ KIT INTELECT VET 2CH COMBO PKG, 2782/ INTELECT TRANSPORT US STD, 2895K/ KIT CART ADAPT BL W/CT/SPEC US, 2872/ VECTRA GEN 2C COMBO W/O EMG PK US STD, 2876/ VECTR GEN 2C COMBO W/O EMG US STD W/CART, 2874/ VECTRA GEN 4C COMBO W/O EMG PK US STD, 2878/ VECTR GEN 4C COMBO W/O EM US STD W/CART, 7550/ INT LEGEND COMBO 4C US STD, INT001/ INTELECT LEGEND ULTRASOUND US STD, INTC B/ INT CB PKGD US STD, 39-0701/ DIRECT SUPPLY PANACEA VECTRA 2-CHNL ULTRASOUND/ESTIM COMBO, 39-0702/ DIRECT SUPPLY PANACEA VECTRA 4-CHNL ULTRASOUND/ESTIM COMBO, 13-4248/ GEL CONDUCTOR 24-8.5OZ BOTTLES, 15-1200/ INTELECT MOBILE 2 ULTRASOUND INTL SET EU PLUG, 15-1201/ INTELECT MOBILE 2 ULTRASOUND INTL SET ALL PLUGS, 15-1204/ INTELECT MOBILE 2 COMBO INTL SET EU PLUG, 15-1205/ INTELECT MOBILE 2 COMBO INTL SET ALL PLUGS, 2173KIT/ INTELECT RPW 2 120V INTERNATIONAL KIT US PLUG, 2174KIT/ INTELECT RPW 2 230V KIT EU PLUG, 2175KIT/ INTELECT RPW 2 100V KIT JPN PLUG, 2176KIT/ INTELECT RPW 2 120V USA KIT, 12-2756-1/ INTELECT VET 2CH COMBO PKG INTL STD, 2756K/ KIT INTELECT VET 2CH COMBO PKGUS STD, 70002/ NEO MODULE ULTRASOUND

    FDA Enforcement
    Class I ·Ongoing·DJO, LLC·October 13, 2021

    This is an accessory to Intelect Advanced, Intelect Mobile, Intelect Neo, and V-Sonic devices. NYLATEX WRAP - Product Usage: are intended to be used based on the devices associated with them. Nylatex wraps are composed of nylon and natural rubber and are accessories used to secure electrodes or thermal therapy to a patient.

    FDA Enforcement
    Class II ·Terminated·DJO, LLC·July 22, 2020

    Cobra x5 1-CH EMG ET Tube, 6.0mm, REF: LTE700S-5, Rx Only, Sterile EO UDI: B006:TE700S52$$7050918B - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open airway for patient ventilation during surgical or parasurgical care using any compatible nerve monitoring system.

    FDA Enforcement
    Class II ·Terminated·Neurovision Medical Products Inc·September 2, 2020

    Cobra x5 2-Ch EMG ET Tube, 6.0mm, REF: LTE700DCS-5, Rx Only, Sterile EO UDI: B006LTE700DCS52/$$7062618C - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open airway for patient ventilation during surgical or parasurgical care using any compatible nerve monitoring system.

    FDA Enforcement
    Class II ·Terminated·Neurovision Medical Products Inc·September 2, 2020

    Cobra x5 2-Ch EMG ET Tube, 8.0mm, REF: LTE700DCL-5, Rx Only, Sterile EO UDI: B006LTE700DCL52 - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open airway for patient ventilation during surgical or parasurgical care using any compatible nerve monitoring system.

    FDA Enforcement
    Class II ·Terminated·Neurovision Medical Products Inc·September 2, 2020

    Cobra x5 1-Ch EMG ET Tube, 8.0mm, REF: LTE700L-5, Rx Only, Sterile EO UDI: B006LTE700L52$$7061318B - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open airway for patient ventilation during surgical or parasurgical care using any compatible nerve monitoring system.

    FDA Enforcement
    Class II ·Terminated·Neurovision Medical Products Inc·September 2, 2020

    Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 6.0mm REF NVTKIT-C6-5, Rx Only, Sterile, UDI: B006NVTKITC652/$$7061918A - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open airway for patient ventilation during surgical or parasurgical care using any compatible nerve monitoring system.

    FDA Enforcement
    Class II ·Terminated·Neurovision Medical Products Inc·September 2, 2020

    Cobra x5 2-Ch EMG ET Tube, 7.0mm, REF: LTE700DCM-5, Rx Only, Sterile EO UDI: B006LTE700DCM52 - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open airway for patient ventilation during surgical or parasurgical care using any compatible nerve monitoring system.

    FDA Enforcement
    Class II ·Terminated·Neurovision Medical Products Inc·September 2, 2020

    Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 8.0 mm, REF NVTKIT-C8-5, Rx Only, Sterile UDIB006NVTKITC852/$$7062118C - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open airway for patient ventilation during surgical or parasurgical care using any compatible nerve monitoring system.

    FDA Enforcement
    Class II ·Terminated·Neurovision Medical Products Inc·September 2, 2020

    Cobra x5 1-Ch EMG ET Tube, 7.0mm, REF LTE700M-5, Rx Only, Sterile EO CE UDI: B006LTE700M52/$$7061418C - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open airway for patient ventilation during surgical or parasurgical care using any compatible nerve monitoring system.

    FDA Enforcement
    Class II ·Terminated·Neurovision Medical Products Inc·September 2, 2020

    Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMT ET Tube, 7.0mm REF: NVTKIT-C7-5, RxOnly, Sterile, UDI: B006NvtKITc752/$$7062818C - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open airway for patient ventilation during surgical or parasurgical care using any compatible nerve monitoring system.

    FDA Enforcement
    Class II ·Terminated·Neurovision Medical Products Inc·September 2, 2020

    Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement; List Number: LN 6K89-30. Intended for the in vitro quantitative determination of Ammonia (NH3) in human plasma.

    FDA Enforcement
    Class II ·Terminated·Sentinel CH SpA·November 4, 2015

    MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41; IVD. Intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems The product is a medical device (chemistry reagent) and is intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems. The kit is provided as a ready to use liquid material consisting in two components: Reagent 1 and Reagent 2. According to the catalogue number, the kit is composed of three vials of 48 ml for Reagent 1 and three vials of 18 ml for Reagent 2 in the configuration 8L24-31. The configuration 8L24-41 consists in ten vials of 90 ml for Reagent 1 and ten vials of 34 ml for Reagent 2

    FDA Enforcement
    Class II ·Terminated·Sentinel CH SPA·August 9, 2017

    Alinity c Lithium Reagent Kit- intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c Systems and the Alinity c analyzer List Number: 08P5320

    FDA Enforcement
    Class II ·Terminated·Sentinel CH SpA·October 2, 2019

    MULTIGENT Lithium-intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c Systems and the Alinity c analyzer List Number: 8L25-30

    FDA Enforcement
    Class II ·Terminated·Sentinel CH SpA·October 2, 2019

    Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in the calibration of the Alinity c CRP Vario assay, Cardiac CRP high sensitivity method [Cardiac CRP], on the Alinity c analyzer.

    FDA Enforcement
    Class III ·Terminated·Sentinel CH SpA·October 13, 2021