740 results
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33ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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The Medline General Surgery Tray is customized to meet requirements of the hospitals and health care professionals utilizing them. The kit is provided sterile, single-use and includes a range of components dependent upon the specific procedure. These kits will be assembled using Medline and other manufacturers medical device components and drug components in some cases. Customers specify the kit contents, quantity, and placement of individual items in the kit.
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 3, 2025
Medline Kits containing BD SureStep Foley Tray Systems: SKU/Description: CDS984076J GYN ROBOTIC DYNJG001004A LAVH MINOR DYNJG901001B CRANIOTOMY DYNJ908819B KIT CRANIOTOMY (only units from SKU DYNJG001004A LAVH MINOR were distributed)
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 3, 2025
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: C-SECTION PREP, REF DYNJ32702B
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 30, 2025
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: LABOR TRIAGE KIT, REF DYKM1564
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 30, 2025
SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·August 6, 2025
Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: 1) CC DRAWER 4 IV CIRCULATION, REF ACC010254B; 2) CC ADULT DRAWER 2, REF ACC010256; 3) PEDI EMERGENCY TRAY-BLUE, REF ACC010316A; 4) ADULT DRAWER 4, REF ACC010389C; 5) DRAWER 4 - SUMMIT, REF ACC010627; 6) DRAWER 3, REF ACC010898.
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 9, 2025
Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: IV START BOX, REF ACC010665
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 9, 2025
Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: RETINAL PACK-LF, REF DYNJ0151148B
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 9, 2025
Centurion Sterile Weitlaner Retractor 3 x 4 Prong, Reorder: I68395
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·May 21, 2025
Centurion Sterile Weitlaner Retractor, Reorder: 67315
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·May 21, 2025
Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 2, 2025
Medline Convenience kits used for various procedures: 1) LABOR AND DELIVERY PACK-LF, Model Number: DYNJ26971L; 2) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ0378319P; 3) VUWC OB PACK, Model Number: DYNJ64017B; 4) OB PROTECTION PACK NO GAUZE, Model Number: DYNJHTLD04A; 5) PACK VAGINAL DELIVERY, Model Number: HM190A; 6) VAGINAL DELIVERY PACK, Model Number: SYNJ10248B; 7) OB PROTECTION PACK NO GAUZE, Model Number: DYNJ84209; 8) VAG DELIVERY PACK-6220, Model Number: DYNJ49542B; 9) FHT VAG DELIVERY PACK, Model Number: DYNJ37124C; 10) VAGINAL DEL PK, Model Number: DYNJ65689; 11) PK,L&D-VAG DEL, Model Number: DYNJ43737D; 12) L&D PACK-LF, Model Number: DYNJ0731657M; 13) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ43604B; 14) VAD ACCESS, Model Number: DYNJ24276C; 15) VAGINAL DELIVERY PACK, Model Number: DYNJ80304; 16) VAGINAL DELIVERY CDS, Model Number: CDS982762I; 17) VAGINAL DELIVERY, Model Number: DYNJ903796C; 18) VAGINAL DELIVERY PACK, Model Number: DYNJ43677D; 19) VAGINAL DELIVERY PACK, Model Number: DYNJ43677D; 20) BR L&D PACK, Model Number: DYNJ47625B; 21) OB PACK, Model Number: DYNJ03387B; 22) OB PROTECTION PACK NO GAUZE, Model Number: DYNJHTLD04A; 23) VAGINAL DELIVERY TRAY, Model Number: MNS7460A; 24) VAGINAL DELIVERY PACK, Model Number: DYNJ23158B; 25) L AND D PACK, Model Number: DYNJHTLD03A; 26) PK,L&D-VAG DEL, Model Number: DYNJ43737D; 27) VAG DELIVERY PACK, Model Number: DYNJ34949; 28) OB PACK, Model Number: DYNJ55835B; 29) VAGINAL DELIVERY PACK, Model Number: DYNJ68778A; 30) OB PACK, Model Number: DYNJ83115; 31) VAGINAL DEL PK, Model Number: DYNJ65689; 32) LDRP-OBSTETRICAL PACK-LF, Model Number: DYNJ64828B; 33) LABOR & DELIVERY PACK, Model Number: DYNJ69433; 34) LABOR & DELIVERY II-LF, Model Number: DYNJS8250; 35) VAGINAL DELIVERY PACK-MARY IMM, Model Number: DYNJ24514G; 36) CUSTOM VAGINAL DELIVERY, Model Number: DYNJ63270C; 37) BHS STANDARD VAGINAL DELIVERY, Model Number: DYNJ80329; 38) OB VAGINAL PACK-LF, Model Number: DYNJ40009D; 39) DELIVERY PACK ME-LF RF, Model Number: DYNJ45589F; 40) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ82620A; 41) VAGINAL DELIVERY, Model Number: DYNJ903796C; 42) DELIVERY PACK, Model Number: DYNJ69964; 43) VAGINAL DELIVERY PACK, Model Number: DYNJ34315D; 44) VAGINAL DELIVERY PACK, Model Number: DYNJ57668A; 45) VAG DELIVERY PACK CHS-LF, Model Number: DYNJ35608K; 46) O.B. PACK-LF, Model Number: DYNJ07520J; 47) OB PROTECTION PACK NO GAUZE, Model Number: DYNJ84209; 48) VAGINAL DELIVERY PACK, Model Number: DYNJ68778A; 49) CUH VAGINAL-LF, Model Number: DYNJC9242C; 50) VAGINAL DELIVERY, Model Number: DYNJ903796C; 51) VAGINAL DELIVERY, Model Number: DYNJ907958; 52) VAG DEL PROCEDURE MCSETX, Model Number: DYNJ908581A; 53) CUH VAGINAL-LF, Model Number: DYNJC9242C; 54) VAGINAL DELIVERY, Model Number: DYNJ903796C; 55) VAGINAL DELIVERY, Model Number: DYNJ907958
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·April 23, 2025
Medline Convenience kits used for various procedures: 1) RHINOPLASTY PACK, Model Number: DYNJ84116A
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·April 23, 2025
Medline Convenience kits used for various procedures: 1) STANDARD D&C, Model Number: DYNJ69733; 2) NHS - LAP BOWEL GNG, Model Number: DYNJ39904A; 3) LAPAROSCOPY GYN SURGERY PA, Model Number: DYNJ64651A; 4) GYNE - LITHOTOMY MAJOR-LF, Model Number: DYNJ49250F; 5) ENS. GYNE LITHOMIE MINEURE-LF, Model Number: DYNJ47552C; 6) CH D&C PACK, Model Number: DYNJ67945; 7) LAP GYN PACK-LF, Model Number: DYNJ25892K; 8) GYN LAPAROSCOPY PACK BJC-LF, Model Number: DYNJ41670B; 9) OPP GYN VAGINAL PACK, Model Number: DYNJ67227; 10) GYNE MINOR LAPAROSCOPY GRH-LF, Model Number: DYNJ41790F; 11) GYNE - LITHOTOMY MINOR PACK-LF, Model Number: DYNJ49251C; 12) STANDARD D&C, Model Number: DYNJ69733; 13) PERI GYN PACK, Model Number: DYNJ24338I; 14) GYN LAPAROSCOPY CDS, Model Number: CDS982727L; 15) ROBOTICS, Model Number: DYNJ908712B
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·April 23, 2025
Medline Convenience kits used for various procedures: 1) T A PACK, Model Number: DYNJ67791A; 2) NASAL PACK, Model Number: DYNJ66514; 3) ENT PACK, Model Number: DYNJ67775A; 4) T/A ENDO PACK, Model Number: DYNJ83158; 5) T & A PACK, Model Number: DYNJ0634878I; 6) PPM-ICD PACK-LF, Model Number: DYNJ15949D; 7) TONSIL PACK, Model Number: DYNJ44525C; 8) ENT TRAY, Model Number: DYNJ44391K; 9) ENT PACK, Model Number: DYNJ49300D; 10) NASAL PACK, Model Number: DYNJ61555B; 11) HEAD AND NECK, Model Number: DYNJ57287A; 12) SINUS ENDOSCOPY-LF, Model Number: DYNJ36720F; 13) ENT PACK, Model Number: DYNJ54035B; 14) ENT PACK, Model Number: DYNJ36516; 15) FESS PACK, Model Number: DYNJ59502B; 16) T AND A PACK, Model Number: DYNJ80790; 17) PK,ENT, Model Number: DYNJ57583; 18) ENT/LAP PACK, Model Number: DYNJ84876; 19) TONSIL PACK, Model Number: DYNJ50109B; 20) TONSIL, Model Number: DYNJ908452C; 21) CSS SINUS PACK, Model Number: DYNJ17005I; 22) ENT, Model Number: DYNJ910514; 23) ADULT ENT - OAKBEND, Model Number: DYNJ905762; 24) EENT SPLIT PACK-LF, Model Number: LLSCAENT01; 25) ENT PACK, Model Number: DYNJ31453D; 26) ENT PACK, Model Number: DYNJ59447A; 27) TONSIL PACK, Model Number: DYNJ26441R; 28) ORAL ENT PACK, Model Number: DYNJ58408A; 29) ENT PACK, Model Number: DYNJ51085; 30) DR LANO NASAL CHRISTUS, Model Number: DYNJ61196A; 31) ENT PACK, Model Number: DYNJ66178D; 32) BWNBORO EENT PACK-LF, Model Number: DYNJ37551A; 33) HEAD AND NECK PACK, Model Number: DYNJ68872F; 34) EENT PACK, Model Number: DYNJ50301C; 35) ENT PACK, Model Number: DYNJ40498B; 36) SHN-C-THYROIDECTOMY-LF, Model Number: DYNJ46869A; 37) MINOR CYSTO PACK, Model Number: DYNJ58727D; 38) TONSILS AND ADENOIDS, Model Number: DYNJ45171C; 39) T&A PACK, Model Number: DYNJ56543J; 40) ENT PACK, Model Number: DYNJ54035B; 41) TONSIL PACK, Model Number: DYNJ50109B; 42) ENT PACK, Model Number: DYNJ40139D; 43) NASAL/SEPTO PACK, Model Number: DYNJ32099A; 44) EENT SPLIT PACK-LF, Model Number: LLSCAENT01; 45) ENT PACK, Model Number: DYNJ53573A; 46) CHS ENT PACK II, Model Number: DYNJCH908; 47) SIMPLE NECK DISSECTION, Model Number: DYNJ47481F; 48) TONSIL PACK, Model Number: DYNJ81479A; 49) E.N.T. TRAY, Model Number: DYNJ22357K; 50) NASAL PACK, Model Number: DYNJ39317B; 51) HEAD AND NECK PACK, Model Number: DYNJ54321D; 52) T A PACK, Model Number: DYNJ67791A; 53) ENT PACK, Model Number: DYNJ42451B; 54) HEAD AND NECK PACK-FOX, Model Number: DYNJ53348C; 55) HEAD AND NECK PACK, Model Number: DYNJ58596B; 56) SINUS PACK, Model Number: DYNJ56262; 57) ENT PACK, Model Number: DYNJ51085; 58) TONSIL T AND A PACK SHD, Model Number: DYNJ68417C; 59) ENT PACK, Model Number: DYNJ48595; 60) T AND A PACK-LF, Model Number: DYNJ52611; 61) HEAD AND NECK PACK, Model Number: DYNJ81897B; 62) ENSEMBLE ORL THYROIDE-LF, Model Number: DYNJ43390A; 63) EENT PACK-LF, Model Number: DYNJ34728D; 64) ENT, Model Number: DYNJ910514; 65) TONSIL ADENOID CKHA-LF, Model Number: DYNJ41771C; 66) ENT PACK, Model Number: DYNJ68679B; 67) PACK,T & A ASC, Model Number: DYNJ906914; 68) EENT SPLIT PACK-LF, Model Number: LLSCAENT01; 69) ENT PACK, Model Number: DYNJ83603; 70) ENT PACK, Model Number: DYNJ32247; 71) PPM-ICD PACK-LF, Model Number: DYNJ15949D; 72) ENT PACK, Model Number: DYNJ31453D; 73) SINOSCOPY PACK-LF, Model Number: DYNJ25600L; 74) T & A PACK, Model Number: DYNJ38978C; 75) CSC-N T&A, Model Number: DYNJ50870D; 76) ENT I-LF, Model Number: DYNJS0702; 77) ENT KIT, Model Number: DYNJ902836F; 78) ENT PACK, Model Number: DYNJ66039B; 79) TONSIL CDS, Model Number: DYNJ907844D; 80) PACK,T & A ASC, Model Number: DYNJ906914
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·April 23, 2025
Medline Convenience kits used for various procedures: 1) OCULOPLASTIC PICK PACK, Model Number: DYNJ43914B; 2) PLASTIC PACK, Model Number: DYNJ65109; 3) PLASTIC PROCEDURE PACK, Model Number: DYNJ34160D; 4) MINOR BREAST SJHC-LF, Model Number: DYNJ84991; 5) PLASTIC PACK, Model Number: DYNJ66056; 6) MUSCLE PLASTIC PACK, Model Number: DYNJ66212A; 7) MINOR PLASTIC PACK, Model Number: DYNJ37231B; 8) GENERAL BREAST GRH-LF, Model Number: DYNJ52658D; 9) GENERAL BREAST GRH-LF, Model Number: DYNJ52658D; 10) FACE PACK, Model Number: DYNJ37316D; 11) PLASTIC PACK-LF, Model Number: DYNJ57440D; 12) MINOR BREAST SJHC-LF, Model Number: DYNJ84991; 13) MINOR PLASTIC PACK, Model Number: DYNJ37231B; 14) SATELLITE MINOR PLASTIC PACK, Model Number: DYNJ63696; 15) FACIAL/EYE PACK, Model Number: DYNJ68328; 16) BREAST PACK, Model Number: DYNJ63753; 17) BREAST PACK, Model Number: DYNJ63753; 18) TUMMY PACK, Model Number: DYNJ64886A; 19) PLASTIC TORSO PK TEGH-LF, Model Number: DYNJ46737A; 20) PLASTIC BREAST PACK, Model Number: DYNJ40620F; 21) PLASTIC ENT PACK, Model Number: DYNJ64712B; 22) PLASTIC SURGERY SERV-DR GARAZO, Model Number: DYNJ34199A; 23) OCULOPLASTIC PICK PACK, Model Number: DYNJ43914B; 24) OCULAR PLASTICS, Model Number: DYNJ55985D; 25) TUMMY PACK, Model Number: DYNJ64886A; 26) MUSCLE PLASTIC PACK, Model Number: DYNJ66212A; 27) ZURI BREAST PACK, Model Number: DYNJ67772A; 28) PLASTIC TORSO PK TEGH-LF, Model Number: DYNJ46737A; 29) TUMMY PACK, Model Number: DYNJ64886A; 30) OCCULAR PLASTIC PACK, Model Number: DYNJ35741D; 31) FACELIFT PACK, Model Number: DYNJ38907; 32) BREAST PACK, Model Number: DYNJ67882; 33) KDOP PLASTIC PACK, Model Number: DYNJ37142D
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·April 23, 2025
Medline Convenience kits used for various procedures: 1) UTHET TYLER OB PACK, Model Number: DYNJ68673; 2) D AND C PACK, Model Number: DYNJ66290A; 3) D & C PACK-LF, Model Number: DYNJ24159C; 4) OB PACK, Model Number: DYNJ54484A; 5) PERI GYN-LF, Model Number: DYNJS3040; 6) D&C, Model Number: DYNJ900422F; 7) D&C HYSTEROSCOPY CDS, Model Number: CDS985201A; 8) D AND C PACK, Model Number: DYNJ66290A; 9) D&C PACK, Model Number: DYNJ47616B; 10) WMC D & C PACK-LF, Model Number: DYNJ50656B; 11) TRANSVAGINAL PACK, Model Number: DYNJ36599; 12) OB PACK, Model Number: DYNJ25915G; 13) PERI GYN-LF, Model Number: DYNJS3040; 14) MEMORIAL D AND C PACK, Model Number: DYNJ0989660A; 15) HYSTEROSCOPY PACK, Model Number: DYNJ64226A; 16) OB PACK, Model Number: DYNJ64571; 17) WMC D & C PACK-LF, Model Number: DYNJ50656B; 18) D & C PACK-LF, Model Number: DYNJT2535G; 19) OB PACK, Model Number: DYNJ44522B; 20) OB PACK-LF, Model Number: DYNJ26121G; 21) NYGH-HYSTEROSCOPY-LF, Model Number: DYNJ905534C; 22) NYGH-HYSTEROSCOPY-LF, Model Number: DYNJ905534C; 23) NYGH-HYSTEROSCOPY-LF, Model Number: DYNJ905534C; 24) NYGH-HYSTEROSCOPY-LF, Model Number: DYNJ905534C
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·April 23, 2025
Medline Convenience kits used for various procedures: 1) SKIN LESION SET, Model Number: MNS6270
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·April 23, 2025
Medline Convenience kits used for various procedures: 1) DR. KHAN CABG ADDS PACK, Model Number: DYNJ59310D; 2) CARDIAC STERNAL PACK, Model Number: DYNJ32436A; 3) VEIN CLOSURE PACK, Model Number: DYNJ35586G; 4) ABLATION PACK-LF, Model Number: DYNJ55343B; 5) ABLATION PACK-LF, Model Number: DYNJ55343B; 6) CARDIAC PACK, Model Number: DYNJ65027B; 7) VASCULAR PACK-LF, Model Number: DYNJ48196C; 8) IMPLANT PACK, Model Number: DYNJ40480; 9) OPEN HEART, Model Number: DYNJ900523B; 10) PACEMAKER PACK-LF, Model Number: DYNJ19758I; 11) CHOG VP SHUNT PACK, Model Number: SYNJ10280C; 12) VASCULAR PACK-LF, Model Number: DYNJ48196C; 13) EP PACK-LF, Model Number: DYNJ27949F; 14) PACEMAKER PACK WRO-LF, Model Number: DYNJ41874C; 15) CARDIAC PACK OPTION 1, Model Number: DYNJ83208A; 16) EP DRAPE PACK, Model Number: DYNJ56729; 17) CSTM EP PACEMAKER DRAPE PACK, Model Number: DYNJCD0326; 18) MINOR INTERVENTIONAL TRAY, Model Number: DYNJ80084; 19) CT PACK, Model Number: DYNJ39111A; 20) VASCULAR PACK-LF, Model Number: DYNJ25102I; 21) VASCULAR ACCESS PROCEDURE PACK, Model Number: DYNJ62339; 22) ANGIO TRAY, Model Number: DYNJ43278C; 23) PACEMAKER PACK-LF, Model Number: DYNJ19758I; 24) E.P. BASIC PACK-LF, Model Number: DYNJ24735F; 25) PORT A CATH PACEMAKER BJC-LF, Model Number: DYNJ41683B; 26) PACEMAKER PACK, Model Number: DYNJ39379C; 27) VEIN PACK, Model Number: DYNJ64016B; 28) EP PACK, Model Number: DYNJ68019A; 29) ENDOVENOUS BASIC PACK, Model Number: DYNJ69108A; 30) PACEMAKER PACK-LF, Model Number: DYNJHTCLP101A; 31) EP PACK, Model Number: DYNJ38147C; 32) HEART PRCMNT CHOICE, Model Number: DYNDA1841; 33) PACEMAKER PACK SMGH-LF, Model Number: DYNJ41925I; 34) EP PACK, Model Number: DYNJ81951B; 35) HEALTH ALL VASCULAR PACK-LF, Model Number: DYNJ19538F; 36) OPEN HEART, Model Number: CDS982026V; 37) OPEN HEART, Model Number: CDS982026V
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·April 23, 2025
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: 1) BLOOD CULTURE KIT, REF DYNDH1462B; 2) BLOOD CULTURE KIT, REF DYNDH1622C; 3) BLOOD CULTR KT DIVRSN DEVICE, REF DYNDH1866.
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 30, 2025