BEUDAMED
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    Filters Classification: Class Ii × Status: Ongoing × Clear all

    Sterile Procedural Trays, labeled as the following: a. EAR CDS-LF b. SINUS CDS-1 c. ZALE FESS CDS d. ZALE OTOLOGY CDS e. ZALE HEAD & NECK CDS f. CUH PARA/THYROIDECTOMY CDS g. CAM ENDOSCOPIC SINUS/SEPTO CDS h. HEAD AND NECK CDS i. HEAD AND NECK CDS-LF j. NASAL k. ENT SET UP CDS l. MINOR ENT SINUS PACK-LF m. MAJOR EAR PACK-LF n. THORACOTOMY HARPER PACK-LF o. FESS NSR PACK-LF p. ENT BASIC PACK-LF q. HEAD & NECK-LF r. ENT PACK-LF s. SINOSCOPY-LF t. MAJOR HEAD/NECK PACK-LF u. NECK PACK v. HEAD & NECK PACK w. HEAD & NECK TRAY x. ENT LAW PACK-LF y. ENT PACK z. NECK PACK aa. NASAL PACK bb. ENT PACK cc. FREE FLAP PACK-LF dd. TYMPANO MASTOID ee. MINOR HEAD & NECK #40-RF ff. EAR PACK gg. E.N.T. TRAY hh. EAR PACK-LF ii. BASIC ENT PACK-LF jj. PLASTIC HEAD & NECK PACK kk. EAR TRAY #10-RF ll. HEAD & NECK ENT PACK-RF-LF mm. ENT PACK nn. ENT PACK-LF oo. NASAL/SEPTO PACK pp. OSC FACE LIFT PK qq. RRMC NASAL PACK rr. ENT PACK ss. HENRYS ENT PACK tt. ENT uu. FACE AND NASAL PACK vv. NASAL PACK ww. ENT PACK xx. SINUS ENDOSCOPY-LF yy. OSC NASAL-NOSE PACK-LF zz. ENT PACK aaa. FES PACK - LF bbb. HEAD AND NECK PACK ccc. SCRIPPS SW ENT PACK ddd. SCRIPPS SW EAR PACK-LF eee. HL ENT PACK fff. CAROTID ENDARTECTOMY PK ggg. EAR PACK hhh. ENT FREE FLAP iii. HEAD AND NECK PACK jjj. TRACH PACK kkk. HL EAR PACK lll. NASAL SINUS ENDO PK mmm. ENT PACK nnn. HEAD AND NECK PACK ooo. ENT PACK ppp. HEAD AND NECK PACK qqq. ASC HEAD & NECK PACK rrr. ENT PACK sss. DEACONESS HEAD AND NECK PACK ttt. ENT PACK uuu. BEC MOHS PACK vvv. PK,ENT-EAR www. SVMMC HEAD AND NECK PACK xxx. PK, ENT yyy. HEAD AND NECK PACK zzz. FESS PACK aaaa. PK,ENT-SINUS bbbb. NASAL/HEAD & NECK PACK cccc. ENT PACK dddd. ENT PACK eeee. MAJOR ENT PACK ffff. ENT NECK MMC PACK gggg. HEAD AND NECK PACK hhhh. HEAD AND NECK PACK iiii. HEAD AND NECK PACK jjjj. ORAL PACK kkkk. HMT THORACOSCOPY PACK llll. GU PACK mmmm. HEAD NECKPACK (HNSJC)227-LF nnnn. HEAD AND NECK PLUS I PACK oooo. NASAL PACK pppp. HEAD & NECK PACK-RFD-LF qqqq. ENT PACK rrrr. ENT/H&N PACK ssss. C-SECTION PACK tttt. ENT PACK uuuu. ENT PACK vvvv. ENT PACK wwww. NASAL ENT PACK xxxx. SINUS PACK yyyy. HEAD/NECK PACK zzzz. ENT PACK aaaaa. NASAL PACK bbbbb. FESS PACK ccccc. NASAL SEPTOPLASTY PACK ddddd. ENT PACK eeeee. HEAD&NECK fffff. EAR PACK-LF ggggg. HEAD AND NECK PACK-LF hhhhh. EAR BASIC PACK iiiii. HEAD AND NECK PACK jjjjj. ENT/SEPTO PACK kkkkk. ENT PACK lllll. HEAD & NECK PACK mmmmm. HEAD AND NECK PACK nnnnn. ENT PACK ooooo. ENT PACK-LF ppppp. ENT PACK-LF qqqqq. HL DR PETERS ENT PACK rrrrr. RHINO/SEPTO/FESS PACK sssss. HEAD & NECK ttttt. THYROID/PARATHYROID PACK uuuuu. HEAD AND NECK MINOR PACK vvvvv. PK,ENT wwwww. ENT PACK xxxxx. ENT PACK yyyyy. ENT PACK zzzzz. ENT NECK PACK aaaaaa. ENT PACK bbbbbb. NECK PACK cccccc. EAR TRAY dddddd. HEAD & NECK PACK eeeeee. HEAD & NECK PACK ffffff. MHPB HEAD AND NECK PACK gggggg. NASAL PACK hhhhhh. ENT PACK iiiiii. JHOC EAR TRAY jjjjjj. JHOC HEAD TRAY kkkkkk. ENT I llllll. ENT SHARED mmmmmm. ENT PACK nnnnnn. EENT SPLIT PACK-NO GPAD oooooo. ENT PACK pppppp. HEAD & NECK PACK qqqqqq. NASAL PACK rrrrrr. ENT PACK ssssss. ENT PACK tttttt. ENT PACK uuuuuu. ENT PACK vvvvvv. ENT PACK-LF wwwwww. ENT I-LF xxxxxx. MAJOR HEAD AND NECK PACK yyyyyy. HEAD AND NECK PACK zzzzzz. FACE AND NECK aaaaaaa. ENT PACK bbbbbbb. ENT PACK ccccccc. ENT BASIC PACK-LF ddddddd. ENT PACK-LF eeeeeee. PK, ENT-H&N fffffff. ENT PACK ggggggg. SPRINGS HEAD AND NECK PACK hhhhhhh. ENDO SINUS PACK iiiiiii. HEAD/NECK PACK jjjjjjj. ENT/SINUS PACK-LF kkkkkkk. ENT PACK lllllll. NASAL PACK mmmmmmm. ENT PACK nnnnnnn. ORAL PLASTIC FACIAL PACK ooooooo. ENT HEAD NECK PACK ppppppp. THYROIDECTOMY PACK qqqqqqq. MINOR ORL PACK rrrrrrr. EAR CUSTOM PACK sssssss. MG NS ENT PACK ttttttt. HEAD AND NECK PACK uuuuuuu. ENT PACK vvvvvvv. MAJOR ENT PACK wwwwwww. ENT xxxxxxx. NASAL EAR yyyyyyy. NASAL-LF zzzzzzz. LARGE ENT aaaaaaaa. EAR bbbbbbbb. HEAD AND NECK cccccccc. PAD ENT HEAD & NECK dddddddd. FHT CVOR TAVR eeeeeeee. MODULE NASAL NATALIE ffffffff. ENT-LF gggggggg. HEA

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·February 15, 2023

    MEDLINE convenience kits labeled as: 1) ZALE HEAD & NECK CDS, REF CDS983184I; 2) ENT MINOR, REF CDS983466L; 3) EAR, REF CDS983486K; 4) HEAD AND NECK, REF CDS984259N; 5) HEAD AND NECK, REF CDS984259O; 6) HEAD & NECK CDS, REF CDS984282L; 7) T & A, REF CDS984895I; 8) T & A, REF CDS984895J; 9) T&A, REF CDS984895K; 10) HEAD NECK PACK-LF, REF DYNJ0101206D; 11) HEAD NECK PACK-LF, REF DYNJ0101206F; 12) MAJOR EAR PACK-LF, REF DYNJ0101314D; 13) NILES T A PACK, REF DYNJ0101397M; 14) NILES T A PACK RFID, REF DYNJ0101397N; 15) THYROID PACK-LF, REF DYNJ0131777I; 16) THYROID PACK-LF, REF DYNJ0131777J; 17) THYROID PACK-LF, REF DYNJ0131777K; 18) THYROID PACK-LF, REF DYNJ0131777L; 19) MINOR ENT HARPER PACK-LF, REF DYNJ0160700F; 20) MAJOR ENT HARPER PACK-LF, REF DYNJ0161710G; 21) MAJOR ENT HARPER PACK-LF, REF DYNJ0161710I; 22) T&A PACK, REF DYNJ02462L; 23) ENT/HEAD & NECK PACK, REF DYNJ02463J; 24) ENT BASIC PACK-LF, REF DYNJ0387711F; 25) MAJOR ENT MZ PACK-LF, REF DYNJ0429404O; 26) MAJOR ENT PACK-LF, REF DYNJ0451506P; 27) EAR PACK-LF, REF DYNJ0774664K; 28) MAJOR HEAD/NECK PACK-LF, REF DYNJ0826705N; 29) TRANSPHENOIDAL PACK-LF, REF DYNJ0843898I; 30) MINOR HEAD & NECK #40-RF, REF DYNJ21948S; 31) NASALPLASTY #61-RF, REF DYNJ27320V; 32) DB ENT CSTM PACK-LF, REF DYNJ33585F; 33) ENT RECONSTRUCTION PK, REF DYNJ37531G; 34) BEC MOHS PACK, REF DYNJ43111G; 35) SVMMC HEAD AND NECK PACK, REF DYNJ43776G; 36) TONSIL PACK, REF DYNJ44170G; 37) T AND A PACK, REF DYNJ44982J; 38) MAJOR ENT PACK, REF DYNJ45576B; 39) MAJOR ENT PACK, REF DYNJ48370C; 40) HEAD & NECK PACK, REF DYNJ52419J; 41) HEAD & NECK PK-RFID, REF DYNJ52419K; 42) BL THYROID PK RFID- LF, REF DYNJ52426J; 43) HEAD & NECK PACK, REF DYNJ52758G; 44) THYROID PACK, REF DYNJ53648B; 45) SMH HEAD & NECK PACK, REF DYNJ56995C; 46) CHRISTUS SR HEAD AND NECK PACK, REF DYNJ60922F; 47) HEAD&NECK PACK, REF DYNJ61309B; 48) MHPB HEAD AND NECK PACK, REF DYNJ62032B; 49) SMH THYROID PACK, REF DYNJ62649A; 50) TRANSSPHENOIDAL, REF DYNJ63315B; 51) TYMPANOPLASTY, REF DYNJ63332F; 52) AFCH TONSIL, REF DYNJ63333B; 53) AFCH TONSIL, REF DYNJ63333C; 54) TAC THYROIDECTOMY PACK, REF DYNJ63334C; 55) TAC THYROIDECTOMY PACK, REF DYNJ63334D; 56) HEAD NECK PACK IP, REF DYNJ63336B; 57) HEAD NECK PACK IP, REF DYNJ63336C; 58) THYROID TRAY FFX, REF DYNJ63625C; 59) ENT DRAPE PACK, REF DYNJ63890A; 60) HEAD AND NECK, REF DYNJ64235B; 61) PACK,HEAD AND NECK, REF DYNJ65487B; 62) PEDI ENT PACK, REF DYNJ67401B; 63) ACH HEAD & NECK PACK-LF, REF DYNJ67754B; 64) OSC HEAD AND NECK PACK, REF DYNJ67985B; 65) OSC HEAD AND NECK PACK, REF DYNJ67985C; 66) ENT HEAD NECK PACK, REF DYNJ68211B; 67) ENT BASIC PACK-LF, REF DYNJ69587B; 68) EAR PACK, REF DYNJ82172; 69) ENT MINOR PACK, REF DYNJ82175; 70) ENT MINOR PACK, REF DYNJ82175B; 71) FACIAL PACK, REF DYNJ82177; 72) FACIAL PACK, REF DYNJ82177B; 73) MEDIASTINOSCOPY PACK, REF DYNJ82194; 74) EAR ENT PACK, REF DYNJ82285; 75) HEAD AND NECK PACK, REF DYNJ82654A; 76) HEAD AND NECK PACK, REF DYNJ82654B; 77) GENERAL EAR PACK, REF DYNJ82656C; 78) T AND A PACK, REF DYNJ82657A; 79) T AND A PACK, REF DYNJ82657B; 80) ORAL NASAL, REF DYNJ901073G; 81) ORAL NASAL, REF DYNJ901073I; 82) EAR-LF, REF DYNJ901801K; 83) T&A, REF DYNJ902116I; 84) ENT RESECTION, REF DYNJ902126I; 85) OMFS, REF DYNJ902258J; 86) THYROID, REF DYNJ902508I; 87) HEAD AND NECK, REF DYNJ903810C; 88) TRIPOINT HEAD AND NECK, REF DYNJ904491J; 89) TRIPOINT HEAD AND NECK, REF DYNJ904491K; 90) PLASTIC CRANIOPLASTY-LF, REF DYNJ904558F; 91) CW T&A SINUS, REF DYNJ906052B; 92) HEAD&NECK, REF DYNJ906655F; 93) HEAD&NECK, REF DYNJ906655G; 94) PACK,COCHLEAR IMPLANT, REF DYNJ906901A; 95) HEAD&NECK, REF DYNJ906948B; 96) HEAD&NECK, REF DYNJ906948C; 97) WMC COCHLEAR IMPLANT ADD ON, REF DYNJ907206F; 98) PLASTIC ENT, REF DYNJ907393C; 99) PLASTIC ENT, REF DYNJ907393D; 100) PLASTIC ENT - NTSC, REF DYNJ907411A; 101) ENT-LF, REF DYNJ907577; 102) MINOR ENT # 56653-LF, REF DYNJVB91072

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·December 11, 2024

    Scoot Control R-net, Product Number P015-61. The Scoot Control is intended to support a wheelchair attendant in controlling or maneuvering a power chair

    FDA Enforcement
    Class II ·Ongoing·mo-Vis BVBA·January 17, 2024

    Medline Convenience kits labeled as: 1) CHEST TUBE INSERTION TRAY, Pack Number DYNDA2063; 2) PULL D/C PACK, Pack Number DYNDA2080; 3) STERILE 3CC SYR W/ 23GX1 NDL, Pack Number DYNDA2495; 4) STERILE 1CC SYR W/ 25GX5/8 NDL, Pack Number DYNDA2497; 5) ARTHROGRAM TRAY, Pack Number DYNDH1113; 6) ARTHROGRAM TRAY, Pack Number DYNDH1134; 7) BIOPSY TRAY, Pack Number DYNDH1137C; 8) BREAST BIOPSY TRAY, Pack Number DYNDH1257; 9) OHS CT BIOPSY TRAY -LF, Pack Number DYNDH1270; 10) LUMBAR PUNCTURE TRAY, Pack Number DYNDH1275; 11) ISHAK I.R. BIOPSY TRAY, Pack Number DYNDH1297; 12) ISHAK IR DRAINAGE TRAY, Pack Number DYNDH1300; 13) ULTRASOUND GUIDE BREAST BIOPSY, Pack Number DYNDH1319; 14) LUMBAR PUNCTURE TRAY, Pack Number DYNDH1321; 15) MINI INTERVENTIONAL PACK, Pack Number DYNDH1324B; 16) DIAGNOSTIC TRAY, Pack Number DYNDH1359; 17) LUMBAR TRAY, Pack Number DYNDH1500; 18) TRAY SAFETY LUMBAR PUNCTURE 18GX3.5, Pack Number DYNDH1538; 19) TRAY SAFETY LUMBAR PUNCTURE 20GX3.5, Pack Number DYNDH1539; 20) LUMBAR TRAY, Pack Number DYNDH1540; 21) LUMBAR TRAY, Pack Number DYNDH1540A; 22) BIOPSY PACK, Pack Number DYNDH1556B; 23) BIOPSY KIT, Pack Number DYNDH1570; 24) MYELOGRAM TRAY, Pack Number DYNDH1574; 25) BIOPSY BASIC PACK, Pack Number DYNDH1588; 26) BIOPSY TRAY, Pack Number DYNDH1693; 27) BIOPSY TRAY, Pack Number DYNDH1693A; 28) LUMBAR PUNCTURE TRAY, Pack Number DYNDH1698; 29) BIOPSY PACK, Pack Number DYNDL1462B; 30) LACERATION TRAY, Pack Number DYNDL1774A; 31) LACERATION TRAY, Pack Number DYNDL1887; 32) CT BIOPSY TRAY W/CHLORAPREP, Pack Number DYNJ05162; 33) LUMBAR EPIDURAL TRAY-LF, Pack Number DYNJRA0313B; 34) BIOPSY TRAY - LF, Pack Number DYNJTS0018A; 35) BONE MARROW BIOPSY ASPIRATION, Pack Number DYNJTS0214; 36) MYELOGRAM TRAY W/WATER SOLUBLE, Pack Number DYNJTS04035; 37) LUMBAR TRAY, Pack Number DYNJTS0422; 38) MYELOGRAM TRAY, Pack Number DYNJTS0514; 39) INFANT LUMBAR PUNCTURE TRAY, Pack Number DYNJTS07025; 40) ADULT LUMBAR PUNCTURE TRAY, Pack Number DYNJTS4301; 41) INFANT LUMBAR PUNCTURE TRAY, Pack Number DYNJTS4302; 42) LUMBAR PUNCTURE TRAY, Pack Number DYNJTS4306; 43) LUMBAR PUNCTURE TRAY, Pack Number DYNJTS8100; 44) CENTRAL LINE INSERTION KIT W/16CM CATH, Pack Number ECVC7440A; 45) OB DELIVERY TRAY, Pack Number MNS10875; 46) OB DELIVERY TRAY, Pack Number MNS10875A; 47) CUSTOM BIOPSY TRAY, Pack Number MNS4815; 48) BIOPSY TRAY, Pack Number P151659; 49) ARTHROGRAM PACK, Pack Number P241108; 50) ARTHROGRAM TRAY, Pack Number SPEC0004C; 51) RADIOLOGY PACK-LF, Pack Number SPEC0127; 52) ARTHROGRAM TRAY, Pack Number SPEC0143A; 53) BIOPSY TRAY, Pack Number SPEC0148; 54) RADIOLOGY/BIOPSY, Pack Number SPEC0149; 55) LUMBAR TRAY, Pack Number SPEC0177; 56) DR COPPEL FACET TRAY, Pack Number SPEC0178A; 57) BIOPSY TRAY W/O LIDOCAINE, Pack Number SPEC0196B; 58) LUMBAR TRAY, Pack Number SPEC0197D; 59) ARTHROGRAM TRAY, Pack Number SPEC0221A; 60) ARTHROGRAM TRAY, Pack Number SPEC0232; 61) 22G FACET TRAY, Pack Number SPEC0265A; 62) LUMBAR PUNCTURE TRAY, Pack Number SPEC0289; 63) GLMI ARTHROGRAM KIT:PCL, Pack Number SPEC0300B; 64) ARTHROGRAM TRAY-LF, Pack Number SPEC0400; 65) BIOPSY TRAY-LF, Pack Number SPEC4380; 66) LACERATION TRAY, Pack Number SUT18080; 67) BIOPSY SKIN/LACERATION TRAY, Pack Number SUT20455; 68) UMBILICAL VESSEL TRAY, Pack Number UVT1100A

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024