407 results
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13ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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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
HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144
FDA Enforcement
Class II
·Ongoing·Mizuho OSI·August 31, 2022
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
Genesis Push-In Suture Anchor
FDA Enforcement
Class II
·Ongoing·Aju Pharm Co., Ltd.·February 4, 2026
Fixone Biocomposite Anchor
FDA Enforcement
Class II
·Ongoing·Aju Pharm Co., Ltd.·February 4, 2026
Genesis Knotless Anchor
FDA Enforcement
Class II
·Ongoing·Aju Pharm Co., Ltd.·February 4, 2026
Genesis Dual Thread Screw-In Anchor
FDA Enforcement
Class II
·Ongoing·Aju Pharm Co., Ltd.·February 4, 2026
Genesis Screw-In Anchor
FDA Enforcement
Class II
·Ongoing·Aju Pharm Co., Ltd.·February 4, 2026
AlternatiV+ Max Knotless Anchor
FDA Enforcement
Class II
·Ongoing·Aju Pharm Co., Ltd.·February 4, 2026