714 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Medical Device Exchange -APPLIER, MULTICLIP ROTATING; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 3299; EXP (repackager), Covidien (OEM) Clip, implantable
FDA Recall
Terminated
·EXP Pharmaceutical Services Corp·Product code FCP·February 11, 2015
Schuster Anorectal Manometry Probe. Labeling applied to the ballon pouch reads in part: ''SANDHILL SCIENTIFIC SCHUSTER ANORECTAL MANOMETRY PROBE Rectosphincteric Manometry Balloon Probe Manufactured by: SANDHILL SCIENTIFIC, INC. HIGHLANDS RANCH, COLORADO USA P/N: A86-5050. *** Size: Pediatric... CAUTION: Balloon are made of latex rubber. *** Do not use if latex sensitivity exists.' Additional labeling found on the pouch reads in part: 'Labeling for the device reads in part: 'Cat. 92510 Convertors Self-Seal Pouch 51/4'x10' *** Latex Free *** Distributed by: Cardinal Health McGaw Park, IL ***'.
FDA Recall
Terminated
·Sandhill Scientific, Inc·Product code FAP·December 13, 2005
AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code FIP·June 16, 2022
AquaBplus Water Purification System, Part Number 24-2000-0, AquaBplus 2500 - Typ USA (G02040108-US), AquaBplus 2000 - Typ USA (G02040114-US), AquaBplus HF -Typ USA (G02040120FMC-US)
FDA Recall
Terminated
·Fresenius Medical Care Holdings, Inc.·Product code FIP·August 3, 2021
US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis Vivonic Part Numbers: G02020110 Fresenius Part Number: 24-090A-1
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code FIP·May 16, 2024
Schuster Anorectal Manometry Probe. Labeling applied to the ballon pouch reads in part: ''SANDHILL SCIENTIFIC SCHUSTER ANORECTAL MANOMETRY PROBE Rectosphincteric Manometry Balloon Probe Manufactured by: SANDHILL SCIENTIFIC, INC. HIGHLANDS RANCH, COLORADO USA P/N: A86-4050. *** Size: Adult ... CAUTION: Balloon are made of latex rubber. *** Do not use if latex sensitivity exists.' Additional labeling found on the pouch reads in part: 'Cat. 92510 Convertors Self-Seal Pouch 51/4'x10' *** Latex Free*** Distributed by: Cardinal Health McGaw Park, IL***.'
FDA Recall
Terminated
·Sandhill Scientific, Inc·Product code FAP·December 13, 2005
AmeriWater Portable RO+, model numbers MR01 and MR02. The device is a reverse osmosis system for dialysis.
FDA Recall
Terminated
·Ameriwater Inc·Product code FIP·September 3, 2004
AquaBplus and AquaBplus B2 Water Purification System - Product Usage: Intended for use with a hemodialysis system to remove organic and inorganic substances and microbial contaminants from the water used for hemodialysis or related therapies. Fresenius P/N 24-2500-0 All 3 units make up the AquaBplus 2500Fresenius Part Number: G02040109-US AquaBplus 3000 - Typ USA G02040115-US AquaBplus 2500 - Typ USA G02040120FMC-US AquaBplus HF- Typ USA
FDA Recall
Terminated
·Fresenius Medical Care Holdings, Inc.·Product code FIP·March 18, 2021
AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-US
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code FIP·June 16, 2022
AquaC UNO H [120V, 60Hz, 1000VA, US-Version - a reverse osmosis unit intended for use with hemodialysis systems. Fresenius Part Number: 24-10VA-1 Vivonic Part Number: G02000970-US
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code FIP·June 21, 2022
Medline Convenience kits labeled as: 1) CENTRAL LINE CDS, Pack Number CDS930092U ; 2) SMALL WOUND TRAY, Pack Number DYNDA1822; 3) RADIOLOGY UTILITY TRAY, Pack Number DYNDA2865; 4) BLOOD CULTURE SET , Pack Number DYNDH1495A ; 5) LACERATION TRAY , Pack Number DYNDL1050; 6) LACERATION TRAY , Pack Number DYNDL1062B ; 7) LACERATION TRAY , Pack Number DYNDL1073; 8) LACERATION TRAY , Pack Number DYNDL1076; 9) LACERATION TRAY , Pack Number DYNDL1090A ; 10) ER LACERATION TRAY, Pack Number DYNDL1096; 11) LACERATION TRAY , Pack Number DYNDL1151C ; 12) LACERATION TRAY , Pack Number DYNDL1152A ; 13) LACERATION TRAY , Pack Number DYNDL1152AH; 14) LACERATION TRAY , Pack Number DYNDL1159B ; 15) LACERATION TRAY , Pack Number DYNDL1163; 16) LACERATION TRAY , Pack Number DYNDL1163H ; 17) LACERATION TRAY , Pack Number DYNDL1171; 18) CUSTOM LACERATION TRAY, Pack Number DYNDL1177C ; 19) E. R. LACERATION TRAY , Pack Number DYNDL1187A ; 20) LACERATION TRAY , Pack Number DYNDL1208B ; 21) LACERATION TRAY, Pack Number DYNDL1223A; 22) LACERATION TRAY , Pack Number DYNDL1250C ; 23) LACERATION TRAY , Pack Number DYNDL1257A ; 24) LACERATION TRAY , Pack Number DYNDL1263A ; 25) TRAY,LACERATION , Pack Number DYNDL1271B ; 26) LACERATION TRAY , Pack Number DYNDL1284; 27) LACERATION TRAY , Pack Number DYNDL1285; 28) LACERATION TRAY , Pack Number DYNDL1366A ; 29) LACERATION TRAY , Pack Number DYNDL1368; 30) TRAY,FACIAL PLASTIC LACERATION, Pack Number DYNDL1377A ; 31) TRAY,FACIAL PLASTIC LACERATION, Pack Number DYNDL1377AH; 32) LACERATION TRAY , Pack Number DYNDL1399; 33) LACERATION TRAY , Pack Number DYNDL1403; 34) LACERATION TRAY , Pack Number DYNDL1406A ; 35) TRAY,LACERATION , Pack Number DYNDL1455; 36) LACERATION TRAY , Pack Number DYNDL1457; 37) TRAY LACERATION , Pack Number DYNDL1465; 38) LACERATION TRAY , Pack Number DYNDL1496; 39) LACERATION TRAY , Pack Number DYNDL1496H ; 40) TRAY,LACERATION , Pack Number DYNDL1510; 41) TRAY,LACERATION, Pack Number DYNDL1542; 42) TRAY,LACERATION , Pack Number DYNDL1542; 43) TRAY ER LACERATION, Pack Number DYNDL1569A ; 44) TRAY SM ER LACERATION , Pack Number DYNDL1573; 45) LACERATION TRAY , Pack Number DYNDL1575A ; 46) LACERATION TRAY , Pack Number DYNDL1628A ; 47) LACERATION TRAY , Pack Number DYNDL1634; 48) LACERATION PACK , Pack Number DYNDL1637A ; 49) LACERATION TRAY , Pack Number DYNDL1678; 50) LACERATION TRAY , Pack Number DYNDL1679B ; 51) LACERATION TRAY , Pack Number DYNDL1690; 52) ER LACERATION TRAY, Pack Number DYNDL1693; 53) LACERATION TRAY , Pack Number DYNDL1705; 54) LACERATION TRAY, Pack Number DYNDL1705H ; 55) SUTURE LACERATION KIT , Pack Number DYNDL1707A ; 56) LACERATION TRAY , Pack Number DYNDL1714; 57) LACERATION KIT, Pack Number DYNDL1717; 58) NMG LACERATION TRAY , Pack Number DYNDL1722; 59) LACERATION TRAY , Pack Number DYNDL1728; 60) LACERATION TRAY , Pack Number DYNDL1729; 61) LACERATION TRAY , Pack Number DYNDL1739; 62) LACERATION TRAY , Pack Number DYNDL1740; 63) LACERATION TRAY , Pack Number DYNDL1757; 64) LACERATION TRAY , Pack Number DYNDL1758; 65) LACERATION TRAY, Pack Number DYNDL1758H ; 66) LACERATION TRAY HIGH GRADE, Pack Number DYNDL1762; 67) LACERATION TRAY , Pack Number DYNDL1768; 68) LACERATION TRAY , Pack Number DYNDL1770B ; 69) LACERATION TRAY , Pack Number DYNDL1772; 70) LACERATION TRAY , Pack Number DYNDL1774A ; 71) LACERATION TRAY W/SAFETY NDLS , Pack Number DYNDL1783; 72) LACERATION TRAY , Pack Number DYNDL1790; 73) LACERATION TRAY , Pack Number DYNDL1838; 74) LACERATION TRAY , Pack Number DYNDL1870; 75) LACERATION TRAY , Pack Number DYNDL1870H ; 76) LACERATION TRAY , Pack Number DYNDL1872; 77) LACERATION TRAY W/ UNDERPAD , Pack Number DYNDL1878; 78) LACERATION TRAY , Pack Number DYNDL1887; 79) LACERATION TRAY , Pack Number DYNDL1888; 80) LACERATION TRAY , Pack Number DYNDL1892; 81) LACERATION TRAY , Pack Number DYNDL1920; 82) LACERATION TRAY W/ ADSON FCP, Pack Number DYNDL1923A ; 83) LACERATION TRAY
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code MCY·April 8, 2024
Centurion Forcep kits labeled as: a) STERILE F/P SPLINTER FORCEP (SF6141), Product Code 66165; b) STERILE WEBSTER NEEDLEHOLDER, Product Code 66185; c) STERILE ADSON FORCEP SERR (598), Product Code 66195; d) STERILE DRESSING FORCEP SERR (DF6003), Product Code 66200; e) STERILE TISSUE FORCEP W/TEETH (TF6015), Product Code 66205; f) STERILE F/P WEBSTER NEEDLEHOLDER FN8064, Product Code 66220; g) STERILE IRIS FORCEP W/TEETH (IF250), Product Code 66275; h) STERILE TUBE CLAMP (TOC500), Product Code 66280; i) STERILE F/P SATIN NEEDLEHOLDER (FN9050S), Product Code 66355; j) STERILE 9 1/2 SPONGE FORCEP (237), Product Code 66360; k) STERILE SATIN NEEDLEHOLDER (FN6060S), Product Code 66375; l) STERILE CURV CRILE FORCEP (CF81810), Product Code 66395; m) STERILE LUCAE FORCEP (BF212), Product Code 66415; n) STERILE 6" SF MAYO NEEDLEHOLDER P/S, Product Code 66430; o) STERILE SATIN FORCEP W/TEETH (AF058S), Product Code 66440; p) STERILE 6" FACIAL NEEDLEHOLDER (FN7070S), Product Code 66470; q) STERILE BAYONET FORCEP (25695), Product Code 66490; r) STERILE WEBSTER NEEDLEHOLDER (WN8080S), Product Code 66500; s) STERILE O-H NEEDLEHOLDER (OHN7098S), Product Code 66510; t) STERILE FEILCHENFELD FORCEP (FS388), Product Code 66515; u) STERILE JEWELERS FORCEP (EA742), Product Code 66560; v) STERILE SATIN IRIS FORCEP W/TEETH IF250S, Product Code 66570; w) STERILE CURV PEAN FORCEP (81890), Product Code 66595; x) STERILE CURV 9-1/2 SPONGE FORCEP (FS950), Product Code 66605; y) STERILE SF MAYO HEGAR NDLHLDR (ST263), Product Code 66655; z) STERILE 6" DRESSING FORCEP (DF6006), Product Code 66755; aa) STERILE MAGILL FORCEP (MAGF9), Product Code 66790; bb) STERILE 7 1/4" TUBE OCCLUDING FORCEP, Product Code 66830; cc) STERILE BAUMGARTNER NEEDLEHOLDER, Product Code 66860; dd) STERILE SATIN IRIS FORCEP CVD. (IF255S), Product Code 66865; ee) STERILE ADSON FORCEP W/TYING PLATFORM, Product Code 66970; ff) ST. WEBSTER NEEDLEHOLDER/LG FINGER LOOPS, Product Code 66975; gg) STERILE CVD IRIS FORCEP (ITF4), Product Code 67005; hh) STERILE FULL CURVED IRIS FORCEP (IF145), Product Code 67015; ii) STERILE UMBILICAL LIL'TIPS FORCEP IF145U, Product Code 67060; jj) STERILE SATIN NEEDLEHOLDER (FN6060SL), Product Code 67115; kk) STERILE SCHNIDT TONSIL FORCEP, Product Code 67170; ll) STERILE BISHOP HARMON FORCEP, Product Code 67175; mm) STERILE MAYO HEGAR NEEDLEHOLDER 8"(16290, Product Code 67260; nn) STERILE UTERINE FORCEP 10" (82810), Product Code 67310; oo) STERILE 8" STR PEAN FORCEP (PF12202), Product Code 67485; pp) STERILE MICRO ADSON FORCEP (AF50MS), Product Code 67505; qq) STERILE ADSON FORCEP MICRO TIP (498MS), Product Code 67560; rr) STERILE PLASTIC FORCEP (BF44), Product Code 67590; ss) STERILE MIXTER FORCEP 5 1/2 (12225), Product Code 67700; tt) STERILE TISSUE FORCEP 8"(TF8000), Product Code 67720; uu) STERILE UMBILICAL FORCEP 1/4 CURVE(IF225, Product Code 67725; vv) STERILE DEBAKEY ATRAUMA FORCEP 8"(22546), Product Code 67740; ww) ST PAS GRADE NEEDLEHOLDER 8"(MHN8PAS), Product Code 67865; xx) ST OR MAYO HEGAR NEEDLEHOLDER 6"(OR2500), Product Code 67870; yy) ST OR GRADE WEBSTER N/HOLDER 5"(OR2200), Product Code 67875; zz) ST.MICRO FORCEP 1/4 CRV SER TIP(MC250), Product Code 67885; aaa) STL IRIS FCP 3 1/2" X-FN ANG TP (IFC35FS, Product Code 67910; bbb) STL IRIS FRCP 3 1/2"X-FN STR TP (IFS35FS, Product Code 67915; ccc) STL ADSON FORCEP SMOOTH TIP (598P), Product Code 67925; ddd) ST.HARTMAN EAR DRESSING FORCEP (AF25714), Product Code 67940; eee) STERILE MAYO HEGAR NEEDLEHOLDER, Product Code 67945; fff) STERILE DRESSING FORCEP SERR (DF6003K), Product Code 66200K; ggg) SPONGE FORCEP STRA 9.5" REPRO STERILE, Product Code 66360K; hhh) STERILE 6" SF MAYO NDL HOLDER REPROCESS, Product Code 66430K; iii) STERILE UTERINE FORCEP 10" REPROCESS, Product Code 67310K; jjj) ST CRILE FORCEP,STR 5 1/2" SERR (SC8042), Product Code I67455; kkk) ST. HALSEY NHLDER 5",PAS QLTY TCI (P/S), Product Code I67975; lll) STR. ALLIGATOR M
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code GEN·February 23, 2024
Centurion Forcep kits labeled as: a) STERILE F/P SPLINTER FORCEP (SF6141), Product Code 66165; b) STERILE WEBSTER NEEDLEHOLDER, Product Code 66185; c) STERILE ADSON FORCEP SERR (598), Product Code 66195; d) STERILE DRESSING FORCEP SERR (DF6003), Product Code 66200; e) STERILE TISSUE FORCEP W/TEETH (TF6015), Product Code 66205; f) STERILE F/P WEBSTER NEEDLEHOLDER FN8064, Product Code 66220; g) STERILE IRIS FORCEP W/TEETH (IF250), Product Code 66275; h) STERILE TUBE CLAMP (TOC500), Product Code 66280; i) STERILE F/P SATIN NEEDLEHOLDER (FN9050S), Product Code 66355; j) STERILE 9 1/2 SPONGE FORCEP (237), Product Code 66360; k) STERILE SATIN NEEDLEHOLDER (FN6060S), Product Code 66375; l) STERILE CURV CRILE FORCEP (CF81810), Product Code 66395; m) STERILE LUCAE FORCEP (BF212), Product Code 66415; n) STERILE 6" SF MAYO NEEDLEHOLDER P/S, Product Code 66430; o) STERILE SATIN FORCEP W/TEETH (AF058S), Product Code 66440; p) STERILE 6" FACIAL NEEDLEHOLDER (FN7070S), Product Code 66470; q) STERILE BAYONET FORCEP (25695), Product Code 66490; r) STERILE WEBSTER NEEDLEHOLDER (WN8080S), Product Code 66500; s) STERILE O-H NEEDLEHOLDER (OHN7098S), Product Code 66510; t) STERILE FEILCHENFELD FORCEP (FS388), Product Code 66515; u) STERILE JEWELERS FORCEP (EA742), Product Code 66560; v) STERILE SATIN IRIS FORCEP W/TEETH IF250S, Product Code 66570; w) STERILE CURV PEAN FORCEP (81890), Product Code 66595; x) STERILE CURV 9-1/2 SPONGE FORCEP (FS950), Product Code 66605; y) STERILE SF MAYO HEGAR NDLHLDR (ST263), Product Code 66655; z) STERILE 6" DRESSING FORCEP (DF6006), Product Code 66755; aa) STERILE MAGILL FORCEP (MAGF9), Product Code 66790; bb) STERILE 7 1/4" TUBE OCCLUDING FORCEP, Product Code 66830; cc) STERILE BAUMGARTNER NEEDLEHOLDER, Product Code 66860; dd) STERILE SATIN IRIS FORCEP CVD. (IF255S), Product Code 66865; ee) STERILE ADSON FORCEP W/TYING PLATFORM, Product Code 66970; ff) ST. WEBSTER NEEDLEHOLDER/LG FINGER LOOPS, Product Code 66975; gg) STERILE CVD IRIS FORCEP (ITF4), Product Code 67005; hh) STERILE FULL CURVED IRIS FORCEP (IF145), Product Code 67015; ii) STERILE UMBILICAL LIL'TIPS FORCEP IF145U, Product Code 67060; jj) STERILE SATIN NEEDLEHOLDER (FN6060SL), Product Code 67115; kk) STERILE SCHNIDT TONSIL FORCEP, Product Code 67170; ll) STERILE BISHOP HARMON FORCEP, Product Code 67175; mm) STERILE MAYO HEGAR NEEDLEHOLDER 8"(16290, Product Code 67260; nn) STERILE UTERINE FORCEP 10" (82810), Product Code 67310; oo) STERILE 8" STR PEAN FORCEP (PF12202), Product Code 67485; pp) STERILE MICRO ADSON FORCEP (AF50MS), Product Code 67505; qq) STERILE ADSON FORCEP MICRO TIP (498MS), Product Code 67560; rr) STERILE PLASTIC FORCEP (BF44), Product Code 67590; ss) STERILE MIXTER FORCEP 5 1/2 (12225), Product Code 67700; tt) STERILE TISSUE FORCEP 8"(TF8000), Product Code 67720; uu) STERILE UMBILICAL FORCEP 1/4 CURVE(IF225, Product Code 67725; vv) STERILE DEBAKEY ATRAUMA FORCEP 8"(22546), Product Code 67740; ww) ST PAS GRADE NEEDLEHOLDER 8"(MHN8PAS), Product Code 67865; xx) ST OR MAYO HEGAR NEEDLEHOLDER 6"(OR2500), Product Code 67870; yy) ST OR GRADE WEBSTER N/HOLDER 5"(OR2200), Product Code 67875; zz) ST.MICRO FORCEP 1/4 CRV SER TIP(MC250), Product Code 67885; aaa) STL IRIS FCP 3 1/2" X-FN ANG TP (IFC35FS, Product Code 67910; bbb) STL IRIS FRCP 3 1/2"X-FN STR TP (IFS35FS, Product Code 67915; ccc) STL ADSON FORCEP SMOOTH TIP (598P), Product Code 67925; ddd) ST.HARTMAN EAR DRESSING FORCEP (AF25714), Product Code 67940; eee) STERILE MAYO HEGAR NEEDLEHOLDER, Product Code 67945; fff) STERILE DRESSING FORCEP SERR (DF6003K), Product Code 66200K; ggg) SPONGE FORCEP STRA 9.5" REPRO STERILE, Product Code 66360K; hhh) STERILE 6" SF MAYO NDL HOLDER REPROCESS, Product Code 66430K; iii) STERILE UTERINE FORCEP 10" REPROCESS, Product Code 67310K; jjj) ST CRILE FORCEP,STR 5 1/2" SERR (SC8042), Product Code I67455; kkk) ST. HALSEY NHLDER 5",PAS QLTY TCI (P/S), Product Code I67975; lll) STR. ALLIGATOR M
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·April 10, 2024
Medline Convenience kits labeled as: 1) CENTRAL LINE CDS, Pack Number CDS930092U ; 2) SMALL WOUND TRAY, Pack Number DYNDA1822; 3) RADIOLOGY UTILITY TRAY, Pack Number DYNDA2865; 4) BLOOD CULTURE SET , Pack Number DYNDH1495A ; 5) LACERATION TRAY , Pack Number DYNDL1050; 6) LACERATION TRAY , Pack Number DYNDL1062B ; 7) LACERATION TRAY , Pack Number DYNDL1073; 8) LACERATION TRAY , Pack Number DYNDL1076; 9) LACERATION TRAY , Pack Number DYNDL1090A ; 10) ER LACERATION TRAY, Pack Number DYNDL1096; 11) LACERATION TRAY , Pack Number DYNDL1151C ; 12) LACERATION TRAY , Pack Number DYNDL1152A ; 13) LACERATION TRAY , Pack Number DYNDL1152AH; 14) LACERATION TRAY , Pack Number DYNDL1159B ; 15) LACERATION TRAY , Pack Number DYNDL1163; 16) LACERATION TRAY , Pack Number DYNDL1163H ; 17) LACERATION TRAY , Pack Number DYNDL1171; 18) CUSTOM LACERATION TRAY, Pack Number DYNDL1177C ; 19) E. R. LACERATION TRAY , Pack Number DYNDL1187A ; 20) LACERATION TRAY , Pack Number DYNDL1208B ; 21) LACERATION TRAY, Pack Number DYNDL1223A; 22) LACERATION TRAY , Pack Number DYNDL1250C ; 23) LACERATION TRAY , Pack Number DYNDL1257A ; 24) LACERATION TRAY , Pack Number DYNDL1263A ; 25) TRAY,LACERATION , Pack Number DYNDL1271B ; 26) LACERATION TRAY , Pack Number DYNDL1284; 27) LACERATION TRAY , Pack Number DYNDL1285; 28) LACERATION TRAY , Pack Number DYNDL1366A ; 29) LACERATION TRAY , Pack Number DYNDL1368; 30) TRAY,FACIAL PLASTIC LACERATION, Pack Number DYNDL1377A ; 31) TRAY,FACIAL PLASTIC LACERATION, Pack Number DYNDL1377AH; 32) LACERATION TRAY , Pack Number DYNDL1399; 33) LACERATION TRAY , Pack Number DYNDL1403; 34) LACERATION TRAY , Pack Number DYNDL1406A ; 35) TRAY,LACERATION , Pack Number DYNDL1455; 36) LACERATION TRAY , Pack Number DYNDL1457; 37) TRAY LACERATION , Pack Number DYNDL1465; 38) LACERATION TRAY , Pack Number DYNDL1496; 39) LACERATION TRAY , Pack Number DYNDL1496H ; 40) TRAY,LACERATION , Pack Number DYNDL1510; 41) TRAY,LACERATION, Pack Number DYNDL1542; 42) TRAY,LACERATION , Pack Number DYNDL1542; 43) TRAY ER LACERATION, Pack Number DYNDL1569A ; 44) TRAY SM ER LACERATION , Pack Number DYNDL1573; 45) LACERATION TRAY , Pack Number DYNDL1575A ; 46) LACERATION TRAY , Pack Number DYNDL1628A ; 47) LACERATION TRAY , Pack Number DYNDL1634; 48) LACERATION PACK , Pack Number DYNDL1637A ; 49) LACERATION TRAY , Pack Number DYNDL1678; 50) LACERATION TRAY , Pack Number DYNDL1679B ; 51) LACERATION TRAY , Pack Number DYNDL1690; 52) ER LACERATION TRAY, Pack Number DYNDL1693; 53) LACERATION TRAY , Pack Number DYNDL1705; 54) LACERATION TRAY, Pack Number DYNDL1705H ; 55) SUTURE LACERATION KIT , Pack Number DYNDL1707A ; 56) LACERATION TRAY , Pack Number DYNDL1714; 57) LACERATION KIT, Pack Number DYNDL1717; 58) NMG LACERATION TRAY , Pack Number DYNDL1722; 59) LACERATION TRAY , Pack Number DYNDL1728; 60) LACERATION TRAY , Pack Number DYNDL1729; 61) LACERATION TRAY , Pack Number DYNDL1739; 62) LACERATION TRAY , Pack Number DYNDL1740; 63) LACERATION TRAY , Pack Number DYNDL1757; 64) LACERATION TRAY , Pack Number DYNDL1758; 65) LACERATION TRAY, Pack Number DYNDL1758H ; 66) LACERATION TRAY HIGH GRADE, Pack Number DYNDL1762; 67) LACERATION TRAY , Pack Number DYNDL1768; 68) LACERATION TRAY , Pack Number DYNDL1770B ; 69) LACERATION TRAY , Pack Number DYNDL1772; 70) LACERATION TRAY , Pack Number DYNDL1774A ; 71) LACERATION TRAY W/SAFETY NDLS , Pack Number DYNDL1783; 72) LACERATION TRAY , Pack Number DYNDL1790; 73) LACERATION TRAY , Pack Number DYNDL1838; 74) LACERATION TRAY , Pack Number DYNDL1870; 75) LACERATION TRAY , Pack Number DYNDL1870H ; 76) LACERATION TRAY , Pack Number DYNDL1872; 77) LACERATION TRAY W/ UNDERPAD , Pack Number DYNDL1878; 78) LACERATION TRAY , Pack Number DYNDL1887; 79) LACERATION TRAY , Pack Number DYNDL1888; 80) LACERATION TRAY , Pack Number DYNDL1892; 81) LACERATION TRAY , Pack Number DYNDL1920; 82) LACERATION TRAY W/ ADSON FCP, Pack Number DYNDL1923A ; 83) LACERATION TRAY
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024