12 results
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8ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Medline Convenience kits labeled as: 1) NHP BREAST BIOPSY PACK, Pack Number DYNJ17400B; 2) BREAST BIOPSY TRAY, Pack Number DYNJ32049A ; 3) BREAST BIOPSY PACK, Pack Number DYNJ44987G ; 4) BREAST BIOPSY PACK, Pack Number DYNJ66288
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024
See full list in RES, exceeds character limit 1) GYN LAPAROSCOPY CDS, Model Number: CDS981504G; 2) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407P; 3) ROBOTIC GYN CDS-1, Model Number: CDS982893I; 4) GYN LAPAROSCOPY CDS, Model Number: CDS983300J; 5) NHP ROBOTIC GYNE CDS, Model Number: CDS984243G; 6) ROBOTIC-LF, Model Number: CDS984543D; 7) ROBOTIC-LF, Model Number: CDS984543F; 8) ROBOTIC-LF, Model Number: CDS984543G; 9) ROBOTIC-LF, Model Number: CDS984543I; 10) GYN CDS, Model Number: CDS984860F; 11) GYN LAP PELVI, Model Number: CDS985423G; 12) GYN KIT, Model Number: DYKM1657A; 13) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL100; 14) KIT ROBOTICS GYN, Model Number: DYKMBNDL109; 15) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116D; 16) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116F; 17) KIT GYN VAGINAL MAJOR, Model Number: DYKMBNDL119; 18) KIT GYN VAGINAL MAJOR, Model Number: DYKMBNDL119A; 19) KIT GYN ABDOMINAL MAJOR, Model Number: DYKMBNDL168; 20) KIT GYN ABDOMINAL MAJOR, Model Number: DYKMBNDL168A; 21) KIT THORACIC ROBOTIC LOBECTOMY, Model Number: DYKMBNDL184D; 22) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL91;
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·May 13, 2026
Medline Convenience Kits: 1) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326; 2) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326A; 3) DRAWER #5, Model Number: ACC010475; 4) DRAWER 1 NEURO CART, Model Number: ACC010542; 5) DRAWER 2 NEURO CART, Model Number: ACC010543; 6) DRAWER 4, Model Number: ACC010722; 7) MALIGNANT HYPERTHERMIA CART, Model Number: ACC010896; 8) LIVER TRANSPLANT #57 CDS-2, Model Number: CDS860063U; 9) THOROCOTOMY CDS #24-RF, Model Number: CDS860066T; 10) CYSTO, Model Number: CDS981795G; 11) MAJOR PROCEDURE CDS, Model Number: CDS982414N; 12) TOTAL KNEE CDS, Model Number: CDS982823R; 13) VASCULAR CDS-1, Model Number: CDS982895I; 14) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069F; 15) HEART CABG CDS, Model Number: CDS983376S; 16) CRANIOTOMY, Model Number: CDS983611N; 17) CUH KIDNEY TRANSPLANT CDS, Model Number: CDS983653K; 18) CUH KIDNEY TRANSPLANT CDS, Model Number: CDS983653L; 19) CUH KIDNEY TRANSPLANT CDS, Model Number: CDS983653M; 20) MAJOR ABDOMINAL CDS, Model Number: CDS983908Q; 21) NHP ROBOTIC GENERAL CDS, Model Number: CDS984244I; 22) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431M; 23) MAJOR ABDOMINAL CDS (NO GOWNS), Model Number: CDS985557L; 24) PREP KIT, Model Number: DYK1022113CP; 25) BARRIER KIT,UNIV OF ALABAMA, Model Number: DYK1060193B; 26) PERSONAL ITEM KIT, Model Number: DYKA1131; 27) GI PACK, Model Number: DYKE1441D; 28) GI PACK, Model Number: DYKE1441G; 29) BAPTIST FLOYD BRONCHOSCOPY, Model Number: DYKE1456C; 30) VIDEO BRONCHOSCOPY TRAY, Model Number: DYKE1666; 31) GI LAB OTHER ENDO KIT, Model Number: DYKE1721A; 32) MATERNITY KIT, Model Number: DYKL1343; 33) BUNNY KIT, Model Number: DYKM1054C; 34) ASST STERILE PPE, Model Number: DYKM1270; 35) MASK CAP AND GOWN KIT, Model Number: DYKM1427A; 36) BLOOD PRECAUTION KIT, Model Number: DYKM1687; 37) HELPERS KIT, Model Number: DYKM1832; 38) BRONCHOSPY SUPPLY KIT, Model Number: DYKM1898; 39) OP UROLOGY KIT, Model Number: DYKM2316; 40) ICU PACK, Model Number: DYKM2671; 41) KIT OMF LEFORTE, Model Number: DYKMBNDL1; 42) KIT GEN SURG RECTAL, Model Number: DYKMBNDL103; 43) KIT GEN SURG RECTAL, Model Number: DYKMBNDL103A; 44) KIT GEN SURG RECTAL, Model Number: DYKMBNDL103B; 45) KIT UROLOGY EXPLORATORY, Model Number: DYKMBNDL115; 46) KIT UROLOGY EXPLORATORY, Model Number: DYKMBNDL115A; 47) KIT UROLOGY EXPLORATORY, Model Number: DYKMBNDL115B; 48) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116C; 49) KIT UROLOGY URETHROPLASTY, Model Number: DYKMBNDL117B; 50) KIT UROLOGY LAP PHELAN, Model Number: DYKMBNDL121D; 51) KIT UROLOGY LAP PHELAN, Model Number: DYKMBNDL121G; 52) KIT UROLOGY LAP PHELAN, Model Number: DYKMBNDL121I; 53) KIT ACES INSERT PEG, Model Number: DYKMBNDL130B; 54) KIT OMF PEDS MINOR, Model Number: DYKMBNDL139; 55) KIT THOR ESOPH PERF.REPAIR, Model Number: DYKMBNDL140; 56) KIT NEURO FUS LUM POST SANSUR, Model Number: DYKMBNDL142A; 57) KIT OMF TMJ ARTHROPLASTY (OPEN, Model Number: DYKMBNDL146A; 58) KIT OMF TMJ ARTHROPLASTY (OPEN, Model Number: DYKMBNDL146C; 59) KIT OMF TMJ ARTHROPLASTY (OPEN, Model Number: DYKMBNDL146D; 60) KIT THORACIC THYMECTOMY, Model Number: DYKMBNDL161; 61) KIT ORTHO TOTAL SHOULDER, Model Number: DYKMBNDL162B; 62) KIT LABOR DELIVERY TUBAL LIGAT, Model Number: DYKMBNDL165B; 63) KIT OMF MINOR, Model Number: DYKMBNDL166; 64) KIT TRANSPLANT PARTIAL LIVER, Model Number: DYKMBNDL167; 65) KIT TRANSPLANT PARTIAL LIVER, Model Number: DYKMBNDL167A; 66) KIT TRANSPLANT LIVER EX-LAP, Model Number: DYKMBNDL167B; 67) KIT LAP DONOR NEPHRECTOMY, Model
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·February 25, 2026
Medline Convenience Kits: 1) ROBOTIC GYN CDS-1, Model Number: CDS982893I; 2) GYN LAPAROSCOPY CDS, Model Number: CDS983300J; 3) NHP ROBOTIC GYNE CDS, Model Number: CDS984243G; 4) ROBOTIC-LF, Model Number: CDS984543D; 5) ROBOTIC-LF, Model Number: CDS984543F; 6) ROBOTIC-LF, Model Number: CDS984543G; 7) ROBOTIC-LF, Model Number: CDS984543I; 8) GYN CDS, Model Number: CDS984860F; 9) GYN LAP PELVI, Model Number: CDS985423G; 10) GYN KIT, Model Number: DYKM1657A; 11) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL100; 12) KIT ROBOTICS GYN, Model Number: DYKMBNDL109; 13) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116D; 14) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116F; 15) KIT GYN VAGINAL MAJOR, Model Number: DYKMBNDL119; 16) KIT GYN VAGINAL MAJOR, Model Number: DYKMBNDL119A; 17) KIT GYN ABDOMINAL MAJOR, Model Number: DYKMBNDL168; 18) KIT GYN ABDOMINAL MAJOR, Model Number: DYKMBNDL168A; 19) KIT THORACIC ROBOTIC LOBECTOMY, Model Number: DYKMBNDL184D; 20) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL91; 21) KIT GYN ONCOLOGY, Model Number: DYKMBNDL92; 22) KIT GYN ONCOLOGY, Model Number: DYKMBNDL92A; 23) KIT GYN ABDOMINAL, Model Number: DYKMBNDL92C; 24) KIT GYN LAP, Model Number: DYKMBNDL94; 25) KIT GYN LAP, Model Number: DYKMBNDL94A; 26) KIT GYN LAP, Model Number: DYKMBNDL94C; 27) KIT GYN LAP, Model Number: DYKMBNDL94D; 28) GYN LAPAROSCOPY PACK-LF, Model Number: DYNJ0281948N; 29) PROSTATE ROBOTIC PACK, Model Number: DYNJ0347372F; 30) PROSTATE ROBOTIC PACK, Model Number: DYNJ0347372G; 31) PROSTATE ROBOTIC PACK, Model Number: DYNJ0347372I; 32) HEALTH ALL GYN LAP PACK-LF, Model Number: DYNJ28252G; 33) GYN OPERATIVE LAP PACK-LF, Model Number: DYNJ30005G; 34) OB PACK, Model Number: DYNJ32706B; 35) ROBOTIC UROLOGY-RF, Model Number: DYNJ38844N; 36) ENSEMBLE GYNE LAPAROTOMIE-LF, Model Number: DYNJ47550C; 37) GYN LAP PACK, Model Number: DYNJ47714A; 38) TASC GYN LAP, Model Number: DYNJ49191B; 39) ROBOTIC PACK, Model Number: DYNJ49705K; 40) GYN LAPAROSCOPY PACK, Model Number: DYNJ50348F; 41) NWH GYN LAPAROSCOPY, Model Number: DYNJ50439F; 42) FH LAPAROSCOPIC GYN PK-LF, Model Number: DYNJ51795F; 43) GYN LAPAROSCOPY PACK, Model Number: DYNJ52569B; 44) LAVH PACK, Model Number: DYNJ55862; 45) PK, GEN-LAPAROSCOPY, Model Number: DYNJ57607A; 46) GYN LAPAROSCOPY MRNGSD, Model Number: DYNJ58321A; 47) GYN LAPAROSCOPY PACK, Model Number: DYNJ63079B; 48) GYN LAPAROSCOPY PACK, Model Number: DYNJ63079C; 49) GYN LAPAROSCOPY PACK, Model Number: DYNJ63079D; 50) GYN LAPAROSCOPY PACK, Model Number: DYNJ63079F; 51) GYN DAVINCI PACK, Model Number: DYNJ64266; 52) DAVINCI PACK, Model Number: DYNJ66298D; 53) GYN LAPAROSCOPY, Model Number: DYNJ67269; 54) GENERAL GYN PACK, Model Number: DYNJ68710; 55) LAP GYN PACK, Model Number: DYNJ69419A; 56) LAP GYN PACK, Model Number: DYNJ69419D; 57) GYN LAPAROSCOPY, Model Number: DYNJ81492A; 58) PK, ROBOTIC GYN & GU-ROSE MEDI, Model Number: DYNJ81761A; 59) GYN PACK, Model Number: DYNJ83475A; 60) ROBOTIC XI PACK, Model Number: DYNJ84783; 61) GYN PACK, Model Number: DYNJ86195A; 62) GYN LAPAROSCOPY, Model Number: DYNJ900262A; 63) D&C HYSTEROSCOPY, Model Number: DYNJ901133A; 64) GYN LAPAROSCOPY, Model Number: DYNJ901559J; 65) GYN ENDOSCOPY-LF, Model Number: DYNJ901812J; 66) GYN LITHOTOMY-LF, Model Number: DYNJ902711M; 67) GENERAL ROBOTIC, Model Number: DYNJ905066B; 68) TRINITY C-SEC W/LINEN CDS, Model Number: DYNJ905269G; 69) KIT GYN LAPAROSCOPY RFD, Model Number: DYNJ906322D; 70) GYN LAP LH, Model Number: DYNJ906452C; 71) GYN LAP LH, Model Number: DYNJ906452D; 72) GYN LAP LH, Model Number: DYNJ906452F; 73) FLOYD LITH GYN, Model Number: DYNJ906926B; 74) GYN LAPAROSCOPY-MRMC, Model Number: DYNJ907753F; 75) GYN LAPAROSCOPY-SFMC, Model Number: DYNJ907771C; 76) LAP/GYN ROBOTICS, Model Number: DYNJ908887B; 77) LAP/GYN ROBOTICS, Model Number: DYNJ908887C;
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·February 25, 2026
MEDLINE convenience kits labeled as: 2) ABDOMINAL LAPAROSCOPY, REF CDS760057K; 3) ABDOMINAL LAPAROSCOPY, REF CDS760057L; 4) MAJOR LAPAROTOMY CDS, REF CDS860015W; 5) MINOR LAPAROTOMY CDS, REF CDS860016P; 6) MINOR LAPAROTOMY CDS, REF CDS860016Q; 7) MINOR LAPAROTOMY CDS, REF CDS860016R; 8) LAPAROTOMY CDS #31-RF, REF CDS860062R; 9) LAPAROTOMY CDS #31-RF, REF CDS860062S; 10) LAPAROSCOPY CDS, REF CDS860194I; 11) BASIC LAPAROSCOPY CDS, REF CDS920080R; 12) BASIC LAPAROSCOPY CDS, REF CDS920080S; 13) BASIC LAPAROSCOPY CDS, REF CDS920080T; 14) GENERAL LAPAROSCOPY, REF CDS930027U; 15) GENERAL LAPAROSCOPY, REF CDS930027V; 16) MINOR BASIC-LF, REF CDS930120G; 17) MINOR BASIC-LF, REF CDS930120I; 18) MAJOR DRAPE-LF, REF CDS930121L; 19) GENERAL LAPAROSCOPY PROCEDURE, REF CDS930125U; 20) GENERAL MINOR CDS, REF CDS980246V; 21) MAJOR PROCEDURE-LF, REF CDS980255T; 22) MAJOR LAPAROTOMY, REF CDS981133K; 23) MAJOR LAPAROTOMY KIT, REF CDS981316T; 24) MINOR KIT, REF CDS981317V; 25) BAPTIST NORTH MAJOR CDS, REF CDS982410L; 26) MINOR PROCEDURE CDS-LF, REF CDS982923N; 27) GEN SURG LAPAROSCOPY CDS-LF, REF CDS982926L; 28) LAPAROTOMY CDS, REF CDS983412I; 29) GENERAL LAPAROSCOPY CDS, REF CDS983418I; 30) MINOR-LF, REF CDS983862D; 31) MAJOR ABDOMINAL CDS, REF CDS983908P; 32) LAP CHOLE CDS, REF CDS983912W; 33) LAP CHOLE CDS, REF CDS983912X; 34) GENERAL SURGERY CDS, REF CDS983914L; 35) NHP GENERAL LAPAROSCOPY CDS, REF CDS984232I; 36) GENERAL LAP, REF CDS984251N; 37) ROBOTIC, REF CDS984262M; 38) MINOR CDS, REF CDS984274K; 39) MINOR CDS, REF CDS984274L; 40) MAJOR CDS, REF CDS984277L; 41) MAJOR CDS, REF CDS984277M; 42) SMH MAJOR CDS, REF CDS984588L; 43) MAJOR CDS-LF, REF CDS984599G; 44) MINOR CDS-LF, REF CDS984600G; 45) MINOR PROCEDURE, REF CDS984897K; 46) MINOR PROCEDURE, REF CDS984897L; 47) GENERAL LAPAROSCOPY CDS, REF CDS984901K; 48) GENERAL LAPAROSCOPY CDS, REF CDS984901L; 49) GENERAL LAPAROSCOPY CDS, REF CDS984901M; 50) DAY SURG MAJOR CDS, REF CDS984994M; 51) DAY SURG MAJOR CDS, REF CDS984994N; 52) MINOR SURGERY CDS, REF CDS985321K; 53) LAPAROTOMY CDS-LF, REF CDS985327I; 54) GENERAL LAPAROSCOPY CDS, REF CDS985328J; 55) LAP MAJOR, REF CDS985348F; 56) GENERAL LAPAROSCOPY CDS, REF CDS985422J; 57) GENERAL LAPAROSCOPY CDS, REF CDS985422K; 58) LAPAROTOMY CDS, REF CDS985426I; 59) LAPAROTOMY CDS, REF CDS985426J; 60) LAPAROTOMY CDS, REF CDS985426K; 61) ACH MINOR PROCEDURE, REF CDS985451G; 62) ACH MAJOR ABDOMINAL, REF CDS985454I; 63) SCOPE LAP THOR PACK, REF DYNJ00210L; 64) SCOPE LAP THOR PACK, REF DYNJ00210M; 65) MAJOR LAPAROTOMY PACK, REF DYNJ00387O; 66) GER LAPTMPK RFID-LF, REF DYNJ0100957K; 67) LAKELAND HERNIA PACK RFID-LF, REF DYNJ0101477K; 68) SJ EXPLORATORY LAP PACK-LF, REF DYNJ0101482I; 69) SJ EXPLRTRY LP PK RFID-LF, REF DYNJ0101482J; 70) MINOR PACK-LF, REF DYNJ0105608G; 71) LAPAROTOMY PACK-LF, REF DYNJ0161299C; 72) CYSTO PACK, REF DYNJ01920N; 73) LAP CHOLE PACK, REF DYNJ02458P; 74) OPEN HERNIA APPY PACK, REF DYNJ02575F; 75) GENERAL ABDOMINAL PACK-LF, REF DYNJ0271195S; 76) LAPAROTOMY PACK-LF, REF DYNJ0311538N; 77) LAPAROTOMY PACK-LF, REF DYNJ0366425N; 78) MAJOR PACK-LF, REF DYNJ0386381L; 79) DONOR FREE FLAP PACK-LF, REF DYNJ0426069N; 80) LAPAROSCOPY GYN PACK, REF DYNJ05175M; 81) LAPAROTOMY PACK-LF, REF DYNJ0519288N; 82) MINOR PACK-LF, REF DYNJ0531958S; 83) MAJOR PACK-LF, REF DYNJ0531964X; 84) LAP CHOLE PACK-LF, REF DYNJ0537278AD; 85) LAP/CHOLE PACK-LF, REF DYNJ0589896R; 86) LAP/CHOLE PACK-LF, REF DYNJ0589896S; 87) LAP/CHOLE PACK-LF, REF DYNJ0589896T; 88) LAP/CHOLE PACK-LF, REF DYNJ0589896U; 89) LAP/CHOLE PACK-LF, REF DYNJ0589896V; 90) LAKELAND LAP CHOLE PACK-LF, REF DYNJ0619913K; 91) LAKELAND LAP CHOLE PACK-LF, REF DYNJ0619913M; 92) LKLND LP CHL PK RFID-LF, REF DYNJ0619913N; 93) MINOR ABDOMINAL PACK-LF, REF DYNJ0751401Q; 94) MINOR ABDOMINAL PACK-LF, REF DYNJ0751401R; 95) MINOR ABDOMINAL PACK-LF, REF DYNJ0751401S; 96) MAJOR LAPAROTOMY PACK-LF, REF DYNJ0751444S; 97) MAJO
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·December 11, 2024
Medline Convenience kits labeled as: 1) OFFICE PACK FOR HYSTEROSCOPY, Pack Number C040100; 2) LAVH CDS, Pack Number CDS760049AD; 3) LAVH CDS, Pack Number CDS760049AF; 4) MAJOR LITHOTOMY CDS-LF, Pack Number CDS760056G ; 5) ABDOMINAL HYSTERECTOMY CDS-LF , Pack Number CDS760088Q ; 6) ABDOMINAL HYSTERECTOMY CDS-LF , Pack Number CDS760088R ; 7) ABDOMINAL HYSTERECTOMY CDS-LF , Pack Number CDS760088S ; 8) VAGINAL HYSTERECTOMY CDS, Pack Number CDS830186P ; 9) VAGINAL HYSTERECTOMY CDS, Pack Number CDS830186R ; 10) LAVH CDS, Pack Number CDS920130K ; 11) LAVH PROCEDURE, Pack Number CDS980754R ; 12) LAVH PROCEDURE, Pack Number CDS980754S ; 13) VAG HYST KIT, Pack Number CDS981313L ; 14) VAG HYST KIT, Pack Number CDS981313M ; 15) MINOR LITHOTOMY , Pack Number CDS982037W ; 16) MAJOR LITHOTOMY , Pack Number CDS982052V ; 17) D&C CDS , Pack Number CDS982061K ; 18) LAVH, Pack Number CDS982273Q ; 19) LAVH, Pack Number CDS982273R ; 20) LAVH, Pack Number CDS982273S ; 21) BAP NORTH BASIC MINOR GYN CDS , Pack Number CDS982397C ; 22) D&C HYSTEROSCOPY CDS-LF , Pack Number CDS982602K ; 23) GYN LAP HYSTERECTOMY CDS, Pack Number CDS982662P ; 24) GYN LAP HYSTERECTOMY CDS, Pack Number CDS982662Q ; 25) ABDOMINAL HYSTERECTOMY CDS SJF, Pack Number CDS982669N ; 26) GYN LITHOTOMY CDS SJF-LF, Pack Number CDS982679M ; 27) VAGINAL MAJOR , Pack Number CDS982689S ; 28) VAGINAL MAJOR , Pack Number CDS982689T ; 29) GYN/ABDOMINAL , Pack Number CDS982725K ; 30) GYN/ABDOMINAL , Pack Number CDS982725N ; 31) MAG MAJOR VAGINAL CDS , Pack Number CDS982907J ; 32) MAG MAJOR VAGINAL CDS , Pack Number CDS982907M ; 33) VAG HYST/SLING CDS-3, Pack Number CDS983006D ; 34) TOTAL LAPHYSTERECTOMY CDS , Pack Number CDS983055J ; 35) TOTAL LAPHYSTERECTOMY CDS , Pack Number CDS983055K ; 36) CUH LITHOTOMY CDS , Pack Number CDS983207M ; 37) CUH LITHOTOMY CDS , Pack Number CDS983207N ; 38) VAGINAL MINOR , Pack Number CDS983268I ; 39) LAVH CDS, Pack Number CDS983411I ; 40) LAVH CDS, Pack Number CDS983411J ; 41) LAVH CDS, Pack Number CDS983411K ; 42) LAVH PROCEDURE, Pack Number CDS983449L ; 43) LAVH PROCEDURE, Pack Number CDS983449M ; 44) LAVH PROCEDURE, Pack Number CDS983449N ; 45) LAVH CDS, Pack Number CDS983455C ; 46) MAJOR VAGINAL , Pack Number CDS983497J ; 47) MAJOR VAGINAL , Pack Number CDS983497L ; 48) LAPAROTOMY GYN CDS, Pack Number CDS983529M ; 49) VAG HYST CDS, Pack Number CDS983697J ; 50) GYN LITHOTOMY MAJOR LAC CDS , Pack Number CDS983780I ; 51) GYN MAJOR ABDOMINAL LAC CDS , Pack Number CDS983803K ; 52) GYN MINOR CDS , Pack Number CDS983985G ; 53) GYN ABDOMINAL CDS , Pack Number CDS983988A ; 54) MAJOR GYN LAPAROSCOPY CDS , Pack Number CDS984007C ; 55) TVT CDS , Pack Number CDS984091J ; 56) GROTH VAGINAL CDS , Pack Number CDS984201T ; 57) NHP Abdominal Hyst CDS, Pack Number CDS984234J ; 58) GYN CDS , Pack Number CDS984676C ; 59) TSH VAG HYSTERECTOMY CDS, Pack Number CDS985304; 60) TSH VAG HYSTERECTOMY CDS, Pack Number CDS985304A ; 61) DAVINCI HYSTERECTOMY CDS, Pack Number CDS985344F ; 62) HYSTEROSCOPY/D&C, Pack Number CDS985522G ; 63) MAJOR & MINOR LITHOTOMY , Pack Number CDS985525J ; 64) MAJOR LITHOTOMY , Pack Number CDS985547N ; 65) PROCEDURE TRAY, Pack Number DYNDA2966; 66) PERI-GYN PACK-LF, Pack Number DYNJ0038057A ; 67) TVH TRAY, Pack Number DYNJ00460L ; 68) TVH TRAY, Pack Number DYNJ00460M ; 69) D&C HYSTEROSCOPY PACK-LF, Pack Number DYNJ0046646F ; 70) D&C HYSTEROSCOPY PACK-LF, Pack Number DYNJ0046646G ; 71) LAVH PACK-LF, Pack Number DYNJ00470K ; 72) LAVH PACK-LF, Pack Number DYNJ00470L ; 73) MAJOR VAGINAL HARPER PACK-LF, Pack Number DYNJ0161768D ; 74) MAJOR VAGINAL HARPER PACK-LF, Pack Number DYNJ0161768F ; 75) VAG. HYST TRAY-LF , Pack Number DYNJ0209066N ; 76) PERI GYN PACK-LF, Pack Number DYNJ0362432P ; 77) LAVH PACK-LF, Pack Number DYNJ0372824Q ; 78) VAGINAL HYSTERECTOMY PACK-LF, Pack Number DYNJ0373807I ; 79) VAGINAL HYSTERECTOMY PACK-LF, Pack Number DYNJ0373807J ; 80) VAGINAL HYSTERECTOMY PACK-
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024
Medline Convenience kits labeled as: 1) PACK VAGINAL DELIVERY , Pack Number AM185B ; 2) LABOR & DELIVERY CDS, Pack Number CDS830039AF; 3) LABOR & DELIVERY CDS, Pack Number CDS830039AI; 4) LABOR & DELIVERY CDS, Pack Number CDS830039AJ; 5) LABOR & DELIVERY CDS, Pack Number CDS830039AK; 6) VAGINAL DELIVERY CDS, Pack Number CDS830053G ; 7) VAGINAL DELIVERY CDS, Pack Number CDS830053I ; 8) LABOR & DELIVERY, Pack Number CDS830054P ; 9) VAGINAL DELIVERY PACK-LF, Pack Number CDS830116T ; 10) VAG DELIVERY, ROSCOE, Pack Number CDS830118Q ; 11) VAG DELIVERY, ROSCOE, Pack Number CDS830118R ; 12) VAG DELIVERY, ROSCOE, Pack Number CDS830118S ; 13) VAG DELIVERY, ROSCOE, Pack Number CDS830118T ; 14) VAGINAL DEL/RECOV CDS , Pack Number CDS830131J ; 15) VAGINAL DEL/RECOV CDS , Pack Number CDS830131K ; 16) VAGINAL DEL/RECOV CDS , Pack Number CDS830131L ; 17) MAJOR VAGINAL PROCEDURE , Pack Number CDS830136S ; 18) VAGINAL DELIVERY PROCEDURE, Pack Number CDS830137O ; 19) VAGINAL DELIVERY PROCEDURE, Pack Number CDS830137P ; 20) VAGINAL DELIVERY CDS, Pack Number CDS830140A ; 21) VAGINAL DELIVERY CDS, Pack Number CDS830140B ; 22) VAGINAL DELIVERY CDS, Pack Number CDS830178K ; 23) VAGINAL DELIVERY CDS, Pack Number CDS830178L ; 24) VAGINAL DELIVERY CDS, Pack Number CDS830178M ; 25) VAGINAL HYSTERECTOMY CDS, Pack Number CDS830186O ; 26) DELIVERY CDS, Pack Number CDS830199K ; 27) DELIVERY CDS, Pack Number CDS981282O ; 28) OB PROCEDURE-LF , Pack Number CDS981335B ; 29) VAG HYSTERECTOMY CDS, Pack Number CDS981517G ; 30) VAGINAL DELIVERY CDS, Pack Number CDS981776I ; 31) VAGINAL DELIVERY CDS, Pack Number CDS981776J ; 32) VAGINAL DELIVERY CDS, Pack Number CDS981776K ; 33) VAGINAL HYSTERECTOMY CDS, Pack Number CDS982369F ; 34) VAGINAL MAJOR , Pack Number CDS982689O ; 35) VAGINAL MAJOR , Pack Number CDS982689P ; 36) VAGINAL MAJOR , Pack Number CDS982689Q ; 37) VAGINAL MAJOR , Pack Number CDS982689R ; 38) DELIVERY PROCEDURE, Pack Number CDS982761F ; 39) DELIVERY PROCEDURE, Pack Number CDS982761G ; 40) DELIVERY PROCEDURE, Pack Number CDS982761I ; 41) DELIVERY PROCEDURE, Pack Number CDS982761J ; 42) VAGINAL DELIVERY CDS, Pack Number CDS982762D ; 43) VAGINAL DELIVERY CDS, Pack Number CDS982762F ; 44) VAGINAL DELIVERY CDS, Pack Number CDS982762G ; 45) VAGINAL DELIVERY CDS, Pack Number CDS982762I ; 46) VAGINAL DELIVERY CDS, Pack Number CDS982770B ; 47) MAG MAJOR VAGINAL CDS , Pack Number CDS982907K ; 48) MAG MAJOR VAGINAL CDS , Pack Number CDS982907L ; 49) MAG MINOR VAGINAL CDS , Pack Number CDS982908I ; 50) MAG MINOR VAGINAL CDS , Pack Number CDS982908J ; 51) OB-VAGINAL DELIVERY/EMERGENCY , Pack Number CDS982959; 52) VAGINAL DELIVERY CDS, Pack Number CDS983090C ; 53) VAGINAL HYSTERECTOMY CDS, Pack Number CDS983107G ; 54) LABOR & DELIVERY CDS, Pack Number CDS983116C ; 55) LABOR & DELIVERY CDS, Pack Number CDS983116D ; 56) LABOR & DELIVERY CDS, Pack Number CDS983116F ; 57) LABOR & DELIVERY CDS, Pack Number CDS983116G ; 58) LABOR & DELIVERY CDS, Pack Number CDS983116I ; 59) MINOR VAGINAL CDS , Pack Number CDS983119B ; 60) VAGINAL MINOR , Pack Number CDS983268J ; 61) VAGINAL MINOR , Pack Number CDS983268L ; 62) GYN VAGINAL CDS , Pack Number CDS983528J ; 63) ACH MAJOR VAGINAL , Pack Number CDS983641F ; 64) ACH MAJOR VAGINAL , Pack Number CDS983641G ; 65) VAG HYST CDS, Pack Number CDS983697F ; 66) VAGINAL DELIVERY CDS, Pack Number CDS983919C ; 67) VAGINAL DELIVERY CDS, Pack Number CDS983919D ; 68) VAGINAL DELIVERY CDS, Pack Number CDS983919F ; 69) VAGINAL DELIVERY CDS, Pack Number CDS983919G ; 70) OB/GYN CDS, Pack Number CDS984173G ; 71) OB GYN, Pack Number CDS984173I ; 72) GROTH VAGINAL CDS , Pack Number CDS984201P ; 73) GROTH VAGINAL CDS , Pack Number CDS984201Q ; 74) GROTH VAGINAL CDS , Pack Number CDS984201R ; 75) GROTH VAGINAL CDS , Pack Number CDS984201U ; 76) NHP VAGINAL MINOR CDS , Pack Number CDS984235F ; 77) VAGINAL DELIVERY CDS, Pack Number CDS984352C ; 78) VAGINAL DELIVERY CDS, Pack
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024
Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS, Model Number: CDS860015U; 2) MAJOR LAPAROTOMY CDS, Model Number: CDS860015V; 3) MAJOR LAPAROTOMY CDS, Model Number: CDS860015W; 4) MAJOR LAPAROTOMY CDS, Model Number: CDS860015X; 5) MINOR LAPAROTOMY CDS, Model Number: CDS860016P; 6) MINOR LAPAROTOMY CDS, Model Number: CDS860016Q; 7) MINOR LAPAROTOMY CDS, Model Number: CDS860016R; 8) MINOR LAPAROTOMY CDS, Model Number: CDS860016S; 9) LAP GASTRIC BYPASS CDS, Model Number: CDS860146M; 10) NEW LONDON MINOR CDS, Model Number: CDS982518M; 11) NEW LONDON MINOR CDS, Model Number: CDS982518N; 12) NEW LONDON MINOR CDS, Model Number: CDS982518O; 13) NEW LONDON MINOR CDS, Model Number: CDS982518P; 14) GENERAL LAPAROSCOPY CDS, Model Number: CDS983311J; 15) LAVH CDS, Model Number: CDS983411G; 16) NHP ROBOTIC GENERAL CDS, Model Number: CDS984244J; 17) ROBOTIC-LF, Model Number: CDS984543C; 18) CYSTO CDS, Model Number: CDS984592G; 19) CYSTO CDS, Model Number: CDS984592I; 20) ROBOTIC, Model Number: CDS985270F; 21) GENERAL LAPAROSCOPY CDS, Model Number: CDS985422I; 22) ROBOTIC CDS, Model Number: CDS985429L; 23) LAP CHOLE CDS, Model Number: CDS985558N; 24) LAP CHOLE CDS, Model Number: CDS985558O; 25) ENDO KIT, Model Number: DYKE1580A; 26) KIT GEN SURG EXLAP, Model Number: DYKMBNDL105; 27) KIT GEN SURG EXLAP, Model Number: DYKMBNDL105A; 28) KIT GEN SURG EXLAP, Model Number: DYKMBNDL105B; 29) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116; 30) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116B; 31) KIT UROLOGY URETHROPLASTY, Model Number: DYKMBNDL117A; 32) KIT SURG ONC DIAGNOSTIC LAPARO, Model Number: DYKMBNDL12; 33) KIT UROLOGY LAP PHELAN, Model Number: DYKMBNDL121; 34) KIT UROLOGY LAP PHELAN, Model Number: DYKMBNDL121A; 35) KIT UROLOGY LAP PHELAN, Model Number: DYKMBNDL121B; 36) KIT UROLOGY LAP PHELAN, Model Number: DYKMBNDL121C; 37) KIT UROLOGY LAP PHELAN, Model Number: DYKMBNDL121F; 38) KIT L&D CYSTO SETUP, Model Number: DYKMBNDL135A; 39) KIT THORACIC LAPAROSCOPIC HIAT, Model Number: DYKMBNDL136; 40) KIT THORACIC LAPAROSCOPIC HIAT, Model Number: DYKMBNDL136A; 41) KIT THORACIC STAGING LAPAROTOM, Model Number: DYKMBNDL15; 42) KIT SURG ONC LAP DIAG/CV CATH, Model Number: DYKMBNDL153A; 43) KIT SURG ONC LAP DIAG/PORT INS, Model Number: DYKMBNDL153B; 44) KIT LAP DONOR NEPHRECTOMY, Model Number: DYKMBNDL173; 45) KIT LAP DONOR NEPHRECTOMY, Model Number: DYKMBNDL173A; 46) KIT THORACIC HIATAL HERNIA TRA, Model Number: DYKMBNDL175; 47) KIT GEN SURG LAP INGUINAL, Model Number: DYKMBNDL176; 48) KIT GEN SURG LAP INGUINAL, Model Number: DYKMBNDL176A; 49) KIT GEN SURG LAP INGUINAL, Model Number: DYKMBNDL176B; 50) KIT GEN SURG LAP INGUINAL, Model Number: DYKMBNDL176C; 51) KIT THORACIC ROBOTIC LOBECTOMY, Model Number: DYKMBNDL184; 52) KIT THORACIC ROBOTIC LOBECTOMY, Model Number: DYKMBNDL184A; 53) KIT UROLOGY PENILE REPAIR, Model Number: DYKMBNDL188A; 54) KIT UROLOGY LAP SIDDIQUI, Model Number: DYKMBNDL193; 55) KIT UROLOGY LAP SIDDIQUI, Model Number: DYKMBNDL193A; 56) KIT UROLOGY BUCCAL GRAFT, Model Number: DYKMBNDL206; 57) KIT STC PLASTIC FREE FLAP, Model Number: DYKMBNDL54A; 58) KIT UROLOGY CYSTOSCOPY SUPPLEM, Model Number: DYKMBNDL60; 59) KIT UROLOGY CYSTOSCOPY SUPPLEM, Model Number: DYKMBNDL60A; 60) KIT UROLOGY MINOR, Model Number: DYKMBNDL61A; 61) KIT UROLOGY MINOR, Model Number: DYKMBNDL61B; 62) KIT GEN SURG LAP COLECTOMY, Model Number: DYKMBNDL73; 63) KIT GEN SURG LAP COLORECTAL, Model Number: DYKMBNDL73A; 64) KIT GEN SURG LAP COLORECTAL, Model Number: DYKMBNDL73B; 65) KIT GEN SURG LAP COLORECTAL, Model Number: DYKMBNDL73C; 66) KIT GEN SURG LAP COLORECTAL, Model Number: DYKMBNDL73D; 67) KIT GEN SURG LAP GASTRIC BYPAS, Model Number: DYKMBNDL74; 68) KIT GEN SURG LAP GASTRIC BYPAS, Model Number: DYKMBNDL74A; 69) KIT GEN SURG LAP GASTRIC BYPAS, Model Number: DYKMBNDL74B; 70) KIT GEN SURG LAP GASTRIC BYPAS,
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·February 25, 2026
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·December 4, 2013
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·December 4, 2013
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·December 4, 2013
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·December 4, 2013