80 results
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6ms
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Sources: EU EUDAMED, US FDA
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Number 96-2236; 2) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Number 96-2237M; 3) ECONO STERILE VIENNA NSL SPEC LG STRL CS/25, Model Number 96-2238; for nasal procedures
FDA Enforcement
Class II
·Ongoing·Sklar Instruments·January 22, 2025
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ROCH-PEAN FCP 8" CVD CS/25,Model Number 94-0286; 2) ECONO STERILE DRESSING FCP 5.5" CS/25LG,Model Number 94-0290; 3) ECONO STERILE TISSUE FCP 1X2 5.5" STER CS25,Model Number 94-0291; 4) ECONO STERILE FRCPS JANSEN BAYO STRL6.25 C25,Model Number 941-0691; 5) ECONO STERILE IRIS FCP SERR 4.25 STER CS100,Model Number 941-1414; 6) ECONO STERILE PEDIATRIC MAGILL CATH FCP CS25,Model Number 94-1924; 7) ECONO STERILE STRL ALLIGATOR FCPS 3.5" 25/CS,Model Number 94-5034; 8) ECONO STERILE SERR DRESSING FCP 5 1/2" CS/50,Model Number 94-6146; 9) ECONO STERILE KELLY RANKIN FCP CVD 6.25 CS25,Model Number 94-6616; 10) ECONO STERILE JANSEN NSL FCP BY6.5 STRLCS/25,Model Number 96-2215A; 11) ECONO STERILE BALLENGR SPNG FCP SERR7"CS/25,Model Number 96-2289; 12) ECONO STERILE LUCAE BAYONET FCP SERR5.5CS/25,Model Number 96-2293; 13) ECONO STERILE LUCAE BAYONET FCP SERR5.5CS/25,Model Number 96-2293A; 14) ECONO STERILE RUSSIAN TISSUE FCP 6" STER25,Model Number 96-2295A; 15) ECONO STERILE TISSUE FCP 1X2 8" STRL CS/25,Model Number 96-2351; 16) ECONO STERILE SCHROEDER BRAUN TEN FCP10CS/25,Model Number 96-2386; 17) ECONO STERILE TUBE OCCL FCP SM STR 7"STER 50,Model Number 96-2406; 18) ECONO STERILE TUBE OCC FCP SM STR 7" STER 25,Model Number 96-2408; 19) ECONO STERILE FN-PT SPLINT FCP 4 1/2 STER 50,Model Number 96-2410; 20) ECONO STERILE FN-PT SPLINT FCP 4 1/2 STER 25,Model Number 96-2412; 21) ECONO STERILE FN-PT SPLINT FCP 4 1/2 STER 25,Model Number 96-2412A; 22) ECONO STERILE FN-PT SPLINT FCP 4 1/2 STER 25,Model Number 96-2412M; 23) ECONO STERILE SEMKEN DRESS FCP SERR 5"STER25,Model Number 96-2450M; 24) ECONO STERILE RANKIN KELLY FCP STR6.25 CS/25,Model Number 96-2461; 25) ECONO STERILE RANKIN KELLY FCP CVD6.25 CS/25,Model Number 96-2462; 26) ECONO STERILE IRIS FCP X-FINE ANG 3.5 STER25,Model Number 96-2470A; 27) ECONO STERILE IRIS FCP X-FINE STR 3.5 STER25,Model Number 96-2472A; 28) ECONO STERILE IRIS FCP 1/2CVD SERR STER CS25,Model Number 96-2515; 29) ECONO STERILE IRIS FCP 1/2CVD 1x2 STER CS25,Model Number 96-2515A; 30) ECONO STERILE FOERSTER SPONGE FCP 9.5 STER50,Model Number 96-2532; 31) ECONO STERILE FOERSTER SPONGE FCP 9.5 STER25,Model Number 96-2533; 32) ECONO STERILE FOERSTER SPONGE FCP 9.5 STER25,Model Number 96-2533A; 33) ECONO STERILE SPONGE FCP STR SERR 9.5 STER25,Model Number 96-2533M; 34) ECONO STERILE FOERSTER SPG FCP CVD 9.5STER25,Model Number 96-2534; 35) ECONO STERILE FOERSTER SPG FCP CVD 9.5STER25,Model Number 96-2534A; 36) ECONO STERILE IRIS FCP STR 1X2 4" STER CS/25,Model Number 96-2535A; 37) ECONO STERILE HALSTED FCP STR 5" STER CS/50,Model Number 96-2536; 38) ECONO STERILE HALSTED FCP STR 5" STER CS/50,Model Number 96-2536M; 39) ECONO STERILE HALSTED FCP STR 5" STER CS/25,Model Number 96-2537; 40) ECONO STERILE HALSTED FCP STR 5" STER CS/25,Model Number 96-2537A; 41) ECONO STERILE HALSTED FCP STR 5" STER CS/25,Model Number 96-2537M; 42) ECONO STERILE HALSTED FCP CVD 5" STER CS/50,Model Number 96-2538; 43) ECONO STERILE HALSTED FCP CVD 5" STER CS/25,Model Number 96-2539; 44) ECONO STERILE HALSTED FCP CVD 5" STER CS/25,Model Number 96-2539A; 45) ECONO STERILE HALSTED FCP CVD 5" STER CS/25,Model Number 96-2539M; 46) ECONO STERILE ROCH PEAN FCP STR STER 61/4 50,Model Number 96-2544; 47) ECONO STERILE ROCH PEAN FCP STR STER 61/4 25,Model Number 96-2545; 48) ECONO STERILE ROCH PEAN CVD 6 1/4 STERL CS25,Model Number 96-2547; 49) ECONO STERILE ROCH PEAN CVD 6 1/4 STER CS/25,Model Number 96-2547A; 50) ECONO STERILE ROCH-PEAN FCP CVD 8.5" STER 25,Model Number 96-2548; 51) ECONO STERILE ROCH-PEAN FCP CVD 8.5" STER 50,Model Number 96-2549; 52) ECONO STERILE CRILE FCP STR 5.5" STERL CS/50,Model Number 96-2550; 53) ECONO STERILE CRILE FCP STR 5.5" STERL CS/25,Model Number 96-2551; 54) ECONO STERILE CRILE FCP STR 5.5" STERL CS/25,Model Number 96-2551A;
FDA Enforcement
Class II
·Ongoing·Sklar Instruments·January 22, 2025
Medi Choice Arm Slings ASL 2103 Small 7.5 x 12.5 Inch 1/EA, 24 ENCA ASL 2104 Medium 8 x 15 Inch 1/EA, 24 ENCA ASL 2105 Large 8.5 x 17.5 Inch 1/EA, 24 ENCA ASL 2106 Extra-Large 9 x 20 Inch 1/EA, 24 ENCA ASL 2150 Universal 7 x 18 Inch 1/EA, 24 ENCA Medical - An arm sling is a device intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
FDA Enforcement
Class II
·Terminated·Owens & Minor Distribution, Inc.·December 28, 2016
LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2717H
FDA Enforcement
Class II
·Ongoing·LSL Healthcare Inc.·April 29, 2026
LSL Healthcare, IV Start Kit, Model/Catalog Number: 3131
FDA Enforcement
Class II
·Ongoing·LSL Healthcare Inc.·April 29, 2026
LSL Healthcare, Infant Central Line Dressing Change Kit, Model/Catalog Number: 2925H
FDA Enforcement
Class II
·Ongoing·LSL Healthcare Inc.·April 29, 2026
LSL Healthcare Wound Closure Tray, Model/Catalog Number: 7554
FDA Enforcement
Class II
·Ongoing·LSL Healthcare Inc.·April 29, 2026
LSL Healthcare, Foley Urine Collection Kit, Model/Catalog Number: 1555
FDA Enforcement
Class II
·Ongoing·LSL Healthcare Inc.·April 29, 2026
LSL Healthcare, Standard Central Line Dressing Change Kit, Model/Catalog Number: 2717J
FDA Enforcement
Class II
·Ongoing·LSL Healthcare Inc.·April 29, 2026
LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2519CP, medical procedure convenience kit
FDA Enforcement
Class II
·Ongoing·LSL Healthcare Inc.·February 4, 2026
Dimension Vista¿ Homocysteine Flex Reagent Cartridge (HCYS), Device Listing No.: D017878 is an in vitro diagnostic test for the quantitative measurement of total homocysteine in human serum, heparinized plasma and EDTA plasma on the Dimension Vista System.
FDA Enforcement
Class II
·Terminated·CSL Behring GmbH·July 27, 2016
SIEMENS N Protein Standard SL, for use on the BN II, BN ProSpec Systems, REF/Product Code OQIM 13, Siemens Material Number (SMN)10446073
FDA Enforcement
Class II
·Terminated·CSL Behring GmbH·December 6, 2017
SIEMENS N/T Protein Control SL for use on the BN II, BN ProSpec Systems: N/T Protein Control SL/L: REF/Product Code OQIN19, SMN 10446079 (Low); N/T Protein Control SL/M, REF/Product Code OQIO19, SMN 10446085 (Mid); N/T Protein Control SL/H, REF/Product Code OQIP19, SMN 10446089 (High);
FDA Enforcement
Class II
·Terminated·CSL Behring GmbH·December 6, 2017
N Latex CDT Kit
FDA Enforcement
Class II
·Terminated·CSL Behring GmbH·September 5, 2018
Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum. Siemens Material Number (SMN): 10445997
FDA Enforcement
Class II
·Terminated·CSL Behring GmbH·April 29, 2020
Invacare 9805 and 9805P Hydraulic Patient Lifts, Model Nos. 9805 and 9805P The intended use of a Non-AC-Powered patient lift is to lift and transfer a patient from one surface to another, as from a bed to a wheelchair. The device includes straps and a sling to support the patient.
FDA Enforcement
Class II
·Terminated·Invacare Corporation·December 12, 2018
Endo GIA 45mm Gray Articulating Vascular Reload with Tri-Staple Technology, Item Code EGIA45AV
FDA Enforcement
Class II
·Ongoing·COVIDIEN MEDTRONIC·July 25, 2018
Endo GIA 45 mm Extra Thick Black Articulating Reload with Tri-Staple Technology, Item Code EGIA45AXT
FDA Enforcement
Class II
·Ongoing·COVIDIEN MEDTRONIC·July 25, 2018
Endo GIA 60 mm Extra Thick Black Articulating Reload with Tri-Staple Technology, Item Code EGIA60AXT
FDA Enforcement
Class II
·Ongoing·COVIDIEN MEDTRONIC·July 25, 2018
Tri-Staple 2.0 Intelligent Reload for use with Signia stapling system 30 mm Medium/Thick, Item Code SIG30AMT
FDA Enforcement
Class II
·Ongoing·COVIDIEN MEDTRONIC·July 25, 2018