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KARL STORZ HOPKINS (KSH) I RIGID TELESCOPE, KSH II RIGID TELESCOPE, KSH RIGID OPERATING SCOPES KARL STORZ OVAL SHEATH

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

Strata-G™

FDA UDI
GARRISON DENTAL SOLUTIONS, L.L.C.·00810038090733·Strata-G™ Sectional Matrix System Intro Kit

Strata-G™

FDA UDI
GARRISON DENTAL SOLUTIONS, L.L.C.·00810038090702·Strata-G™ Sectional Matrix System Deluxe Kit

Strata-G™

FDA UDI
GARRISON DENTAL SOLUTIONS, L.L.C.·00810038090719·Strata-G™ Sectional Matrix System Professional Kit

Strata-G™

FDA UDI
GARRISON DENTAL SOLUTIONS, L.L.C.·00810038090757·Strata-G™ Sectional Matrix System Professional Kit

Strata-G™

FDA UDI
GARRISON DENTAL SOLUTIONS, L.L.C.·00810038090740·Strata-G™ Sectional Matrix System Deluxe Kit

Strata-G™

FDA UDI
GARRISON DENTAL SOLUTIONS, L.L.C.·00810038090696·Strata-G™ Sectional Matrix System Intro Kit

GORE® VIATORR® TIPS ENDOPROSTHESIS

FDA Adverse Event
Injury ·W. L. GORE & ASSOCIATES, INC.·Product code MIR·January 11, 2022

Chamber, Environmental For The Storage Of Platelet Concentrate

FDA classification
FDA Class 2 ·Chamber, Environmental For The Storage Of Platelet Concentrate

KASH SALES INC.

FDA registration
KASH SALES INC.·45 products·🇨🇦 Canada

Cardinal Health Presource Kits: 1) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG4; 2) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG5 3) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG6 4) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG7 5) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG8 6) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFGM 7) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFGN 8) KIT,CHP SINUS ENDOSCOPY, Catalog Number:PE36ESCHA 9) KIT, SSSC ENT, Catalog Number:PECGOTSN1 10) KIT, SSSC ENT, Catalog Number:PECGOTSN2 11) KIT, SSSC ENT, Catalog Number:PECGOTSN3 12) KIT, SSSC ENT, Catalog Number:PECGOTSNA 13) KIT, SSSC ENT, Catalog Number:PECGOTSNB 14) KIT, SSSC ENT, Catalog Number:PECGOTSNC 15) KIT, SSSC ENT, Catalog Number:PECGOTSND 16) KIT, SSSC ENT, Catalog Number:PECGOTSNE 17) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA10O 18) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA10P 19) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA10Q 20) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA10R 21) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA10S 22) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA10T 23) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA10Y 24) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA110 25) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA112 26) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA113 27) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA114 28) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA115 29) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA116 30) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA117 31) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA118 32) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA119 33) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA120 34) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA121 35) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA123 36) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA124 37) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA125 38) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA126 39) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA127 40) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA128 41) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA129 42) KIT,ENT ENDOSCOPY,PRESBYTERIAN, Catalog Number:PEV2OT101 43) KIT,ENT ENDOSCOPY,PRESBYTERIAN, Catalog Number:PEV2OT10A 44) KIT,ENT ENDOSCOPY,PRESBYTERIAN, Catalog Number:PEV2OT10B 45) KIT,ENT ENDOSCOPY,PRESBYTERIAN, Catalog Number:PEV2OT10D 46) KIT, MINOR ENT, MERCY, Catalog Number:PEVNMECHE 47) KIT,ENT ENDOSCOPY,PRESBYTERIAN, Catalog Number:PGV2OT10C 48) KIT,ENT SINUS ST LOUIS CHILDRE, Catalog Number:PGVMCLCH1 49) KIT,ENT SINUS ST LOUIS CHILDRE, Catalog Number:PGVMCLCH2 50) KIT,ENT SINUS ST LOUIS CHILDRE, Catalog Number:PGVMCLCH3 51) KIT,ENT SINUS ST LOUIS CHILDRE, Catalog Number:PGVMCLCHA 52) ENDO TRAY SSOP PACK, Catalog Number:SBA23ENPC1 53) ENDO TRAY SSOP PACK, Catalog Number:SBA23ENPC2 54) ENDO TRAY SSOP PACK, Catalog Number:SBA23ENPCB 55) ENDO TRAY SSOP PACK, Catalog Number:SBA23ENPCC 56) ENDO SSOP PACK, Catalog Number:SBA23ENPCD 57) L T P PACK, Catalog Number:SEN11LTCH3 58) L T P PACK, Catalog Number:SEN11LTCH4 59) ENT PACK, Catalog Number:SEN12NSHHT 60) ENT PACK, Catalog Number:SEN12NSHHU 61) ENT, Catalog Number:SEN13ENRU5 62) ENT, Catalog Number:SEN13ENRU6 63) ENT, Catalog Number:SEN13ENRUH 64) NASAL PACK, Catalog Number:SEN13NSCOH 65) NASAL PACK, Catalog Number:SEN13NSCOI 66) RHINOPLASTY NASAL PACK, Catalog Number:SEN13RNNT3 67) RHINOPLASTY NASAL PACK, Catalog Number:SEN13RNNT4 68) RHINOPLASTY NASAL PACK, Catalog Number:SEN13RNNTJ 69) SINUS ENT PACK, Catalog Number:SEN13SNNT1 70) SINUS ENT PACK, Catalog Number:SEN13SNNT2 71) SINUS ENT PACK, Catalog Number:SEN13SNNT3 72) STERILE SINUS ENT PACK, Catalog Number:SEN13SNNTL 73) ENT PACK, Catalog Number:SEN21EPHO1 74) ENT PACK, Catalog Number:SEN21EPHO2 75) ENT PACK, Catalog Number:SEN21EPHO3 76) ENT PACK, Cata

FDA Enforcement
Class II ·Ongoing·Cardinal Health 200, LLC·February 19, 2025

Cardinal Health Presource Kits: 1) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number: PGVMFFBLY; 2) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number: PGVMFFBLZ; 3) KIT,NEURO SPINE,ANDERSON , Catalog Number: PN23SPAM5; 4) KIT, MAJOR SPINE , Catalog Number: PN33MSOC3; 5) KIT, MAJOR SPINE , Catalog Number: PN33MSOCH; 6) KIT, MAJOR SPINE , Catalog Number: PN33MSOCI; 7) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBY6; 8) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBY7; 9) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBY8; 10) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBYD; 11) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBYE; 12) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBYF; 13) KIT, SPINE , Catalog Number: PN40SPMMA; 14) KIT, ORTHO LAMINECTOMY , Catalog Number: PO40LMBY1; 15) KIT, ORTHO LAMINECTOMY , Catalog Number: PO40LMBY2; 16) KIT, ORTHO LAMINECTOMY , Catalog Number: PO40LMBY3; 17) KIT, ORTHO LAMINECTOMY , Catalog Number: PO40LMBY4; 18) KIT, ORTHO LAMINECTOMY , Catalog Number: PO40LMBYC; 19) KIT, ORTHO ANTERIOR CERVICAL , Catalog Number: PO40OAMMA; 20) KIT,WMD SPINE , Catalog Number: PO4ASPWMA; 21) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS951; 22) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS952; 23) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS953; 24) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS954; 25) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS955; 26) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS95F; 27) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS95G; 28) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS95J; 29) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS95K; 30) KIT,ORP MAJOR SPINE , Catalog Number: POHDFSVCD; 31) KIT,ORP MAJOR SPINE , Catalog Number: POHDFSVCE; 32) KIT, ORTHO SPINE , Catalog Number: POHDOSWC1; 33) KIT, ORTHO SPINE , Catalog Number: POHDOSWC2; 34) KIT, ORTHO SPINE , Catalog Number: POHDOSWC3; 35) KIT, ORTHO SPINE , Catalog Number: POHDOSWC4; 36) KIT, ORTHO SPINE , Catalog Number: POHDOSWC5; 37) KIT, ORTHO SPINE , Catalog Number: POHDOSWC6; 38) KIT, ORTHO SPINE , Catalog Number: POHDOSWC7; 39) KIT, ORTHO SPINE , Catalog Number: POHDOSWCB; 40) KIT, ORTHO SPINE , Catalog Number: POHDOSWCC; 41) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV10; 42) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV11; 43) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV12; 44) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV13; 45) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV14; 46) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV15; 47) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV16; 48) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV17; 49) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV18; 50) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC3; 51) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC4; 52) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC5; 53) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC6; 54) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC7; 55) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC8; 56) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC9; 57) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVCI; 58) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVCJ; 59) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVCK; 60) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVCM; 61) KIT, SPINE , Catalog Number: POHFSPMH1; 62) KIT, SPINE , Catalog Number: POHFSPMH2; 63) KIT,ORTHOPLASTIC MICROVASCULAR , Catalog Number: PWVMFFAB10; 64) KIT,ORTHOPLASTIC MICROVASCULAR , Catalog Number: PWVMFFAB11; 65) KIT,ORTHOPLASTIC MICROVASCULAR , Catalog Number: PWVMFFAB12; 66) KIT,ORTHOPLASTIC MICROVASCULAR , Catalog Number: PWVMFFAB13; 67) KIT,ORTHOPLASTIC MICROVASCULAR , Catalog Number: PWVMFFAB14; 68) KIT,ORTHOPLAS

FDA Enforcement
Class II ·Ongoing·Cardinal Health 200, LLC·January 22, 2025

DSH MEDICAL CO., LTD.

FDA registration
DSH MEDICAL CO., LTD.·2 products·🇰🇷 South Korea

KOH YOUNG TECHNOLOGY INC.

FDA registration
KOH YOUNG TECHNOLOGY INC.·1 product·🇰🇷 South Korea

CSH CANNULA

FDA UDI
TSK LABORATORY, JAPAN·04580708063195·CANNULA

CSH CANNULA

FDA UDI
TSK LABORATORY, JAPAN·04580708063034·CANNULA

CSH CANNULA

FDA UDI
TSK LABORATORY, JAPAN·04571225317151·CANNULA

CSH CANNULA

FDA UDI
TSK LABORATORY, JAPAN·04571225317090·CANNULA

CSH CANNULA

FDA UDI
TSK LABORATORY, JAPAN·04571225317120·CANNULA

CSH CANNULA

FDA UDI
TSK LABORATORY, JAPAN·04580708063157·CANNULA