9 results
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8ms
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Sources: EU EUDAMED, US FDA
Yamaha Surface Mounter YR series, YS series, i-Pulse series, Sigma series, S series, M series. Affected models: YSM10, YSM20R(SV)-1, YSM20R(SV)-2, YSM20R-1, YSM20R-2, YSM20-1, YSM20-2, YSM20W-2, YRM20-1, YRM20-2, SIGMA-G5S2, S20, M20 ***Updated as of 6/10/2024*** Surface Mounter model S10, YC8. Component Dispenser model YSD
FDA Enforcement
Class II
·Ongoing·YAMAHA MOTOR CORPORATION·May 29, 2024
Covidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100N, 10005941, DLPM100N, DL10005941, DSPM100N, 10005941-SG, DS10005941, 10005941J, 10005941JP, 10005941JPN
FDA Enforcement
Class II
·Ongoing·Covidien·July 30, 2025
Glucose Hexokinase (Liquid) Reagent For the in vitro quantitative determination of Glucose in serum.
FDA Enforcement
Class II
·Terminated·JAS Diagnostics Inc.·December 24, 2014
Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose in serum.
FDA Enforcement
Class II
·Terminated·JAS Diagnostics Inc.·July 2, 2014
Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent.
FDA Enforcement
Class II
·Terminated·JAS Diagnostics Inc.·July 12, 2017
Drew Scientific Inc. Drew3-PAC. This D3 Reagent Pack includes: diluent reagent 5L, enzymatic cleaner 750 mL, and a lysing reagent 125 mL.
FDA Enforcement
Class II
·Terminated·Jas Diagnostics/Drew Scientific·May 4, 2016
JMS, Japan, 3 WAY, 20 FR 10 mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed in the wall of the tube. One minor lumen is for inflating the retention balloon (available in 2-Way & 3-Way catheters). The second minor lumen (applicable for 3 Way catheters only) is used for bladder irrigation purposes.
FDA Enforcement
Class II
·Terminated·Convatec Inc.·March 26, 2014
Medline brand medical procedure convenience kits, labeled as: 1) CYSTO CDS, REF CDS983525D; 2) CYSTO CDS, REF CDS983525D; 3) CYSTO PACK-LF, REF DYNJ25834B; 4) CYSTO PACK, REF DYNJ35569C; 5) PAVILION MINOR PACK, REF DYNJ40724D; 6) CYSTOSCOPY PACK, REF DYNJ41105C; 7) MINOR PACK, REF DYNJ42132A; 8) RECTAL PRONE PACK, REF DYNJ43380A; 9) HERNIA APPENDECTOMY TEGH-LF, REF DYNJ46716; 10) CYSTO PACK, REF DYNJ47821F; 11) CYSTO PACK, REF DYNJ48978C; 12) CYSTO PACK, REF DYNJ50428C; 13) MID HUDSON CYSTO PACK, REF DYNJ53418B; 14) CYSTO PACK-LF, REF DYNJ55479D; 15) CYSTO PACK, REF DYNJ58445A; 16) MINOR PACK, REF DYNJ58566B; 17) CSTM PK GEN NEW ENGL SURG, REF DYNJ59431; 18) RIDGEWOOD LAP PACK-LF, REF DYNJ60077A; 19) FLEXIBLE CYS PACK, REF DYNJ62111C; 20) CYSTO PACK, REF DYNJ65830A; 21) MAIN & ODS CYSTO PACK, REF DYNJ66821A; 22) PROCEDURE CYSTO PACK, REF DYNJ68883; 23) CYSTO PACK, REF DYNJ69729; 24) MINOR SURGERY PACK, REF DYNJ80004; 25) LAPAROSCOPY PACK, REF DYNJ80763; 26) LAPAROSCOPY PACK, REF DYNJ80763; 27) CYSTO PACK, REF DYNJ82626; 28) MINOR PACK, REF DYNJ83155; 29) SY CYSTO, REF DYNJ900583M; 30) CYSTO, REF DYNJ905569B; 31) CYSTO, REF DYNJ907541A; 32) SET UP PACK-LF, REF LLSCASET01; 33) MAJOR PACK, REF SYNJ910011B
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·October 30, 2024
Medline procedure kits labeled as: 1) ACL ARTHROSCOPY PACK, Pack Number DYNJ55316G; 2) ARTERIOGRAM PACK, Pack Number DYNJ64332; 3) ARTHRO PACK-LF, Pack Number DYNJ38748F; 4) ARTHRO PACK-LF, Pack Number DYNJ38748F; 5) ARTHROGRAM PACK, Pack Number DYNJ65817; 6) ARTHROGRAM TRAY, Pack Number DYNDH1937; 7) ARTHROSCOPY KNEE PACK-LF, Pack Number DYNJ0809731F; 8) ARTHROSCOPY PACK, Pack Number DYNJ66665; 9) ARTHROSCOPY PACK, Pack Number DYNJ38716C; 10) ARTHROSCOPY PACK, Pack Number DYNJ33639J; 11) ARTHROSCOPY PACK, Pack Number DYNJ37707D; 12) ARTHROSCOPY PACK, Pack Number DYNJ38914A; 13) ARTHROSCOPY PACK, Pack Number DYNJ64526A; 14) ARTHROSCOPY PACK, Pack Number DYNJ62755B; 15) ARTHROSCOPY PACK, Pack Number DYNJ61634B; 16) ARTHROSCOPY PACK, Pack Number DYNJ83129; 17) ARTHROSCOPY PACK, Pack Number DYNJ35906F; 18) ARTHROSCOPY PACK, Pack Number DYNJ35906F; 19) ARTHROSCOPY PACK, Pack Number DYNJ37946C; 20) ARTHROSCOPY PACK, Pack Number DYNJ68133A; 21) ARTHROSCOPY PACK BCS, Pack Number DYNJ45629B; 22) ARTHROSCOPY PACK -LF, Pack Number DYNJ0781838S; 23) ARTHROSCOPY PACK-LF, Pack Number DYNJ80469B; 24) ARTHROSCOPY PACK-SHOULDER, Pack Number DYNJ04452L; 25) ARTHROSCOPY PACK-SHOULDER, Pack Number DYNJ24507G; 26) ARTHROSCOPY TRAY, Pack Number DYNJ65948A; 27) ARTHROSCOPY TRAY, Pack Number DYNJ81547; 28) BACK PACK-LF, Pack Number DYNJ0381507N; 29) BASIC ORTHO PACK, Pack Number DYNJ67212A; 30) BASIC SPINE PACK-LF, Pack Number DYNJ39199F; 31) CLOVIS LOWER EXTREMITY-LF, Pack Number DYNJ61066C; 32) CRANIOTOMY PACK, Pack Number DYNJ45145G; 33) CRANIOTOMY PACK-LF, Pack Number DYNJ0530906AO; 34) CRANIOTOMY PACK-LF, Pack Number DYNJ38351O; 35) DL-KNEE SCOPE, Pack Number DYNJ67595B; 36) ENSEMBLE CRANIOTOMIE-LF, Pack Number DYNJ29202D; 37) ESC HAND PACK, Pack Number DYNJ42264; 38) EXTREMITY, Pack Number DYNJ52017; 39) EXTREMITY PACK, Pack Number DYNJ64167D; 40) EXTREMITY PACK, Pack Number DYNJ52104A; 41) EXTREMITY PACK, Pack Number DYNJ53915D; 42) EXTREMITY PACK, Pack Number DYNJ35046B; 43) EXTREMITY PACK, Pack Number DYNJ83732; 44) EXTREMITY PACK, Pack Number DYNJ54684B; 45) EXTREMITY PACK-BELVIDERE, Pack Number DYNJ44692D; 46) EXTREMITY/TRAUMA PACK-LF, Pack Number DYNJ0190688Q; 47) FAIRFIELD KNEE-LF, Pack Number DYNJ30196F; 48) FH PODIATRY PACK-LF, Pack Number DYNJ51796G; 49) FHWC EXTREMITY PACK, Pack Number DYNJ39734D; 50) FOOT AND ANKLE PACK, Pack Number DYNJ65319B; 51) GENERAL ORTHO PACK-LF, Pack Number DYNJ0781892X; 52) GP ARTHROSCOPY KNEE PACK-LF, Pack Number DYNJ0163462Y; 53) GSC KNEE ARTHROSCOPY, Pack Number DYNJ908637; 54) HAND NO SPONGE NOBASIN NOBOWL, Pack Number DYNJ68906; 55) HAND PACK, Pack Number DYNJ44076B; 56) HAND PACK, Pack Number DYNJ60203; 57) HAND PACK, Pack Number DYNJ42329G; 58) HAND PACK, Pack Number DYNJ43386; 59) HAND PACK, Pack Number DYNJ38715C; 60) HAND PACK, Pack Number DYNJ51930A; 61) HAND PACK, Pack Number DYNJ56195C; 62) HAND PACK, Pack Number DYNJ48236I; 63) HAND PACK, Pack Number DYNJ82784; 64) HAND PACK, Pack Number DYNJ55283D; 65) HAND PACK, Pack Number DYNJ44084D; 66) HAND PACK, Pack Number DYNJ46978B; 67) HAND PACK, Pack Number DYNJ81283; 68) HAND PACK, Pack Number DYNJ69908A; 69) HAND PACK XM-LF, Pack Number DYNJ39828D; 70) HAND PACK-LF, Pack Number DYNJ04606G; 71) HAND PACK-LF, Pack Number DYNJ0773815M; 72) HAND PACK-LF, Pack Number DYNJ59960B; 73) HAND/ELBOW PACK, Pack Number DYNJ52097F; 74) HIP PACK, Pack Number DYNJ23762L; 75) HL ACL PACK, Pack Number DYNJ40357C; 76) JOS KNEE PACK, Pack Number PHS977014AK; 77) KNEE ARTH PACK, Pack Number DYNJ83854A; 78) KNEE ARTHROSCOPY, Pack Number DYNJ50313A; 79) KNEE ARTHROSCOPY, Pack Number DYNJ64208; 80) KNEE ARTHROSCOPY PACK, Pack Number DYNJ50682B; 81) KNEE ARTHROSCOPY PACK, Pack Number DYNJ61581A; 82) KNEE ARTHROSCOPY PACK, Pack Number DYNJ41162; 83) KNEE ARTHROSCOPY PACK, Pack Number DYNJ48237J; 84) KNEE ARTHROSCOPY PACK, Pack Number DYNJ39184B; 85) KNEE ARTHROSCOPY PACK, Pack Number D
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·April 2, 2025