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    Centurion Circumsion Trays as follows: Kit Code Product CIT1270 CIRCUMCISION TRAY CIT2365 CIRCUMCISION TRAY CIT2465 CIRCUMCISION TRAY CIT2470 CIRC TRAY W/UNIVERSAL CLAMP CIT2480 CIRCUMCISION TRAY W/CLAMP & 1.3 CM BELL CIT2480 CIRCUMCISION TRAY W/CLAMP & 1.3 CM BELL CIT2510 CIRCUMCISION TRAY W/1.1 CM CLAMP CIT2530A CIRCUMCISION TRAY CIT2545 CIRCUMCISION TRAY CIT2630 CIRCUMCISION TRAY CIT2705 CIRCUMCISION TRAY CIT2730 CIRCUMCISION TRAY CIT3000 CIRCUMCISION TRAY CIT3010 CIRCUMCISION TRAY CIT3100 CIRCUMCISION TRAY CIT3145 UNIVERSAL CIRCUMCISION TRAY W/OUT CLAMP CIT3310 RECYCLABLE CIRCUMCISION TRAY CIT3315 CIRCUMCISION TRAY CIT3345 CIRCUMCISION TRAY CIT3465 L&D CIRCUMCISION SET CIT3690 CIRCUMCISION TRAY CIT3720 CIRCUMCISION TRAY CIT3725 CIRCUMCISION TRAY CIT3730 CIRCUMCISION TRAY CIT3800 CIRCUMCISION TRAY CIT3800 CIRCUMCISION TRAY CIT3835A UNIVERSAL CIRC TRAY W/SURGICAL INST CIT3865 CIRCUMCISION SET W/CLAMP AND 1.1 BELL CIT3890 CIRCUMCISION TRAY CIT4025 CIRCUMCISION TRAY CIT4080 CIRCUMCISION TRAY CIT4080 CIRCUMCISION TRAY CIT4080 CIRCUMCISION TRAY CIT4100 CIRCUMCISION TRAY - NO CLAMP CIT4100 CIRCUMCISION TRAY - NO CLAMP CIT4135 CIRCUMCISION TRAY CIT4140 CIRCUMCISION TRAY CIT4140 CIRCUMCISION TRAY CIT4180 CIRCUMCISION TRAY CIT4230 CIRCUMCISION TRAY CIT4260 CIRCUMCISION SET W/1.1 CLAMP CIT4335 CIRCUMCISION TRAY CIT4370 CIRCUMCISION TRAY CIT4400 CIRCUMCISION TRAY FOR CIRC CLAMP CIT4405 CIRCUMCISION TRAY FOR MOGEN CLAMP CIT4525 CIRCUMCISION TRAY CIT4775 CIRCUMCISION TRAY CIT4835 CIRCUMCISION TRAY WITH 1.3 CIRCLAMP CIT4840 CIRCUMCISION TRAY WITH 1.1 CIRCLAMP CIT4855 1.3 CIRCUMCISION TRAY CLAMP & BELL CIT5030 CIRCUMCISION TRAY CIT5135 UNIVERSAL CIRCUMCISION TRAY CIT5210 CIRCUMCISION TRAY CIT5290 UNIVERSAL CIRCUMCISION TRAY CIT5290 UNIVERSAL CIRCUMCISION TRAY CIT5295 CIRCUMCISION TRAY CIT5300 CIRCUMCISION TRAY CIT5340 CIRCUMCISION TRAY CIT5370 1.3 CIRCUMCISION TRAY CIT5375 CIRCUMCISION TRAY CIT5400 CIRCUMCISION TRAY CIT5460 UNIVERSAL CIRCUMCISION TRAY CIT5470 CIRCUMCISION TRAY W/1.1 BELL & CLAMP CIT5475 CIRCUMCISION TRAY CIT5495 CIRCUMCISION TRAY WITH UNIVERSAL CLAMP CIT5560 CIRC TRAY CIT5580 CIRCUMCISION KIT CIT5615 CIRCUMCISION TRAY CIT5615 CIRCUMCISION TRAY CIT5700 1.3 CIRCUMCISION KIT CIT5735 CIRCUMCISION TRAY CIT5745 CIRCUMCISION TRAY CIT5850 CIRCUMCISION TRAY CIT5955 CIRC TRAY WITH PVP AND SOFT STRAPS CIT6015 CIRCUMCISION TRAY CIT6050 CIRCUMCISION TRAY CIT6090 OSF CIRC TRAY WITH 1.1 CLAMP CIT6090 OSF CIRC TRAY WITH 1.1 CLAMP CIT6120 CIRCUMCISION TRAY CIT6200 CIRCUMCISION TRAY CIT6355 UNIVERSAL CIRCUMCISION TRAY CIT6365 CIRCUMCISION TRAY CIT6445 CIRCUMCISION TRAY CIT6545 CIRC TRAY CIT6560 CIRCUMCISION TRAY CIT6610A CIRCUMCISION TRAY NEWBORN NURSERY CIT6620 CIRCUMCISION TRAY CIT6635 CIRCUMCISION TRAY CIT6670 CIRCUMCISION TRAY CIT6685 CIRCUMCISION TRAY CIT6750 CIRCUMCISION TRAY CIT6860 CIRCUMCISION TRAY CIT6880 CIRCUMCISION TRAY CIT6920 NICU CIRCUMCISION TRAY W/OUT CLAMP CIT6935 CIRCUMCISION TRAY

    FDA Enforcement
    Class II ·Terminated·Centurion Medical Products Corporation·February 12, 2020

    Medline procedural kits labeled as: 1) PERIPHERAL ULTRASOUND CATHETER INSERTION, Pack Number MNS9865; 2) CIRCUMCISION TRAY, Pack Number CIT6715; 3) OSF SMMC CIRCUMCISION KIT, Pack Number CIT7095

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 4, 2024

    Medline procedural kits labeled as: 1) CIRCUMCISION TRAY, Pack Number CIT6715; 2) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920; 3) OSF SMMC CIRCUMCISION KIT, Pack Number CIT7095; 4) RETINAL INJECTION KIT, Pack Number MNS12465; 5) UCLA - BREAST BIOPSY KIT, Pack Number DYNDH1512

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 4, 2024

    Medline procedural kits labeled as: 1) ARTHROGRAM TRAY, Pack Number MNS11965A; 2) ARTHROGRAPH TRAY, Pack Number MNS12670A; 3) CIRCUMCISION TRAY, Pack Number CIT6860A; 4) CIRCUMCISION TRAY, Pack Number CIT6715; 5) CIRCUMCISION TRAY, Pack Number DYNDA2271; 6) CIRCUMCISION TRAY, Pack Number CIT7020; 7) CIRCUMCISION TRAY, Pack Number CIT7210; 8) CIRCUMCISION TRAY, Pack Number CIT6720A; 9) CIRCUMCISION TRAY, Pack Number CIT6665; 10) CIRCUMCISION TRAY , Pack Number CIT6050 ; 11) CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6925; 12) CIRCUMCISION TRAY WITHOUT CLAM, Pack Number CIT6255 ; 13) GLMI ARTHROGRAM KIT:PCL, Pack Number SPEC0300B; 14) MERCY MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780; 15) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920; 16) NICU PROCEDURE TRAY , Pack Number UVT925 ; 17) NURSERY CIRCUMCISION TRAY, Pack Number CIT4845; 18) OSF SMMC CIRCUMCISION KIT, Pack Number CIT7095; 19) PERIPHERAL ULTRASOUND CATHETER INSERTION, Pack Number MNS9865; 20) SHAVE KIT, Pack Number MNS8250; 21) STERILE 1CC SYR W/ 25GX5/8 NDL, Pack Number DYNDA2497; 22) STERILE 1CC SYR W/ 27GX1/2 NDL, Pack Number DYNDA2496; 23) UCLA - BREAST BIOPSY KIT, Pack Number DYNDH1512A; 24) UMBILICAL VES CATH INSERT TRAY, Pack Number UVT3594 ; 25) UMBILICAL VESSEL TRAY W/O CATH, Pack Number UVT170 ; 26) UMBILICAL VESSEL TRAY W/OUT CA, Pack Number UVT475

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 4, 2024

    Medline procedural kits labeled as: 1) DRAWER 3 LAB DRAW & IV START, Pack Number ACC010417 ; 2) DRAWER 3 LAB DRAW & IV START, Pack Number ACC010417A; 3) DRAWER 9L , Pack Number ACC010427A; 4) MEDICATION DELIVERY MODULE, Pack Number ACC010605 ; 5) DRAWER 3, Pack Number ACC010641 ; 6) NEONATAL DRAWER 6 , Pack Number ACC010653 ; 7) DRAWER 2, Pack Number ACC010690 ; 8) ****, Pack Number ACC010690 ; 9) DRAWER 3, Pack Number ACC010784 ; 10) NURSERY CIRCUMCISION TRAY, Pack Number CIT4845; 11) CIRCUMCISION KIT, Pack Number CIT6535; 12) CIRCUMCISION TRAY, Pack Number CIT6720; 13) CIRCUMCISION TRAY, Pack Number CIT6720A; 14) MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780; 15) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920; 16) CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6925; 17) OSF SMMC CIRCUMCISION KIT, Pack Number CIT7095; 18) RETINA LAC/USC PACK , Pack Number CMPJ03205D; 19) AAA PACK-LF, Pack Number CMPJ09869B; 20) ****, Pack Number CMPJ21114P; 21) BRONCHOSCOPY KIT, Pack Number DYKE1764; 22) TRUNK KIT W/OUT EXPIRATION, Pack Number DYKM1360A ; 23) PRE OP KIT, Pack Number DYKS1256B ; 24) CIRCUMCISION TRAY, Pack Number DYNDA2271; 25) DMEK KIT, Pack Number DYNDA3103 ; 26) KIT, NICU - PICU , Pack Number DYNDL1576 ; 27) BASIC EYE PACK-LF , Pack Number DYNJ0413783N ; 28) VASCULAR PACK, Pack Number DYNJ34240I; 29) VASCULAR PACK-LF, Pack Number DYNJ52214 ; 30) SONDHEIMER, Pack Number DYNJ53853C; 31) BUCKLE PACK, Pack Number DYNJ57439A; 32) RETINA CUSTOM PACK, Pack Number DYNJ57970A; 33) AESC PHACO PACK, Pack Number DYNJ58135C; 34) PED RIGHT LEFT HEART PK MHS , Pack Number DYNJ58874 ; 35) PEDIATRIC RIGHT HEART PK MHS, Pack Number DYNJ58875 ; 36) CV MAJOR, Pack Number DYNJ64530 ; 37) ORL BRONCHOSCOPY PACK, Pack Number DYNJ80103A; 38) ISLET CELL , Pack Number DYNJ80490 ; 39) FREE FLAP TRAM ADD ON PACK, Pack Number DYNJ82179 ; 40) FREE FLAP TRAM ADD ON PACK, Pack Number DYNJ82179H; 41) ACCESSORY KIT, Pack Number DYNJ901348D; 42) AAA, Pack Number DYNJ905651B; 43) PROCEDURE TRAY , Pack Number DYNJRA0345F; 44) PROCEDURE TRAY , Pack Number DYNJRA1250B; 45) PROCEDURE TRAY , Pack Number DYNJRA1777; 46) BLOCK TRAY, Pack Number DYNJRA2352; 47) ADULT CORONARY PACK , Pack Number DYNJV0275O; 48) ****, Pack Number DYNJV0275O; 49) NURSING KIT, Pack Number EDUC05026 ; 50) RNSG 2308 , Pack Number EDUC1031; 51) RNSG 2308 , Pack Number EDUC1031H ; 52) RNSG 2201 , Pack Number EDUC1034; 53) RNSG 2201 , Pack Number EDUC1034H ; 54) RETINAL INJECTION KIT, Pack Number MNS12465; 55) ARTHROGRAPH TRAY, Pack Number MNS12670A; 56) PERIPHERAL ULTRASOUND CATHETER INSERTION, Pack Number MNS9865; 57) PERIPHERAL ULTRASOUND CATHETER, Pack Number MNS9865 ; 58) UVT KIT , Pack Number PAIN1396; 59) SHUNT PACK-LF, Pack Number PHS967363W; 60) GLMI ARTHROGRAM KIT:PCL, Pack Number SPEC0300B; 61) GLMI ARTHROGRAM KIT , Pack Number SPEC0300B ; 62) UA/UV CATHETERIZATION TRAY, Pack Number UVT1190B; 63) UMBILICAL TRAY , Pack Number UVT1195 ; 64) UVT KIT , Pack Number UVT1200 ; 65) UVT KIT , Pack Number UVT1200H; 66) UMBILICAL CATH KIT, Pack Number UVT1210 ; 67) UMBILICAL VESSEL TRAY W/O CATH, Pack Number UVT150; 68) UMBILICAL VESSEL CATHETER TRAY, Pack Number UVT665A ; 69) UMBILICAL VESSEL TRAY W/O CATH, Pack Number UVT915

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 4, 2024

    6" (15 cm) Appx 0.85 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 2 Check Valve, 3 Clamps, Rotating Luer;

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·September 21, 2022

    Natural-Knee¿ Congruent Tibial Insert with Screw: SF-CON TIB INS LT SZ1/2 1 SF-CON TIB INS RT SZ1/2 9 SF-CON TIB INS RT SZ3/4/5

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·March 26, 2014

    HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144

    FDA Enforcement
    Class II ·Ongoing·Mizuho OSI·August 31, 2022

    Mizuho Orthopedic Table, model 5855, sub assembly 5855-901 Orthopedic Table Spar.

    FDA Enforcement
    Class II ·Terminated·Mizuho OSI·February 20, 2013

    Mizuho OSI Trios, Table Base; Voltage: 100-240V ~ 50/60 Hz Amps: 5,0-5.0A; Model 7803 and 7803AP Orthopaedic: Operating room tablebase - an electronically powered mobile operating table is created, designed for temporary (<24 hours) support and positioning of a patient in a prone, supine, or lateral position depending on the specific table top utilized.

    FDA Enforcement
    Class II ·Terminated·Mizuho OSI·February 17, 2016

    216 Wilson Frame Pads, Model # 5319-37; Used with Radiolucent Wilson Frames, model numbers 5319G and 5321G. General and Plastic Surgery: These pads are used as a component of the Wilson Frames, which support the torso of a prone patient during spine surgery. The pads are supplied with the frames and as replacements.

    FDA Enforcement
    Class II ·Terminated·Mizuho OSI·April 26, 2017

    Levo Arm Label: LEVO ARM REF 7887-050 MIZUHO OSI Refurbished Levo Arm Label: LEVO ARM REF 7887-050R MIZUHO OSI - Product Usage: used with Mizuho OSI spinal surgery tables to provide patient head support and positioning during spinal surgery.

    FDA Enforcement
    Class II ·Terminated·Mizuho OSI·October 21, 2020

    Mizuho CE IPX4, mode MOT-5602BW, 100-240, 50-60Hz, 400VA, REF 18-140-20 containing hand control Unit - Product Usage: intended to support a patient during surgical operations.

    FDA Enforcement
    Class II ·Ongoing·Mizuho OSI·March 31, 2021

    UFSK Treatment chair 500 XLE- Treatment chair for positioning and support of the patient during diagnostic and therapeutic treatments of temporary to short-term duration, especially in ophthalmology Art.no. / REF no.: 15000004 Art.no. / REF no.: 15000006

    FDA Enforcement
    Class II ·Ongoing·UFSK - International OSYS Gmbh·July 26, 2023

    One Step K in vitro diagnostic test REF: 81A4

    FDA Enforcement
    Class II ·Ongoing·DFI Co., Ltd.·May 13, 2026

    One Step 10A in vitro diagnostic test

    FDA Enforcement
    Class II ·Ongoing·DFI Co., Ltd.·May 13, 2026

    One Step UTI in vitro diagnostic test REF: 3374

    FDA Enforcement
    Class II ·Ongoing·DFI Co., Ltd.·May 13, 2026

    Uric Acid in vitro diagnostic test REF: 31H0P

    FDA Enforcement
    Class II ·Ongoing·DFI Co., Ltd.·May 13, 2026

    One Step pH in vitro diagnostic test REF: 31I4P

    FDA Enforcement
    Class II ·Ongoing·DFI Co., Ltd.·May 13, 2026

    CLARITY II Laser System; Model No. 1110200210.

    FDA Enforcement
    Class II ·Ongoing·Lutronic Corporation·March 18, 2026