96 results
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7ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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Brand Name: Olympus Single Use Electrosurgical Snare SD-400 Product Name: Single Use Electrosurgical Snare Model/Catalog Number: SD-400U-10 Product Description: These instruments have been designed to be used with an Olympus endoscope for the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps, and tissue from within the GI tract.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·November 19, 2025
Brand Name: Olympus Single Use Single Use Electrosurgical Snare SD-400 Product Name: Single Use Single Use Electrosurgical Snare Model/Catalog Number: SD-U400U-15 Product Description: These instruments have been designed to be used with an Olympus endoscope for the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps, and tissue from within the GI tract.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·November 19, 2025
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ARTERIAL LINE START KIT , Model Number ART920; b) ULTRASOUND GUIDED PIV KIT , Model Number BSIPIV1005; c) ULTRASOUND GUIDED IV START KIT W/SHIELD , Model Number BSIPIV1006; d) PIV BSI KIT , Model Number BSIPIV1010; e) ULTRASOUND GUIDED PIV BUNDLE W/CHG DRSG , Model Number BSIPIV1011; f) PICC INSERTION TRAY , Model Number CVI3805; g) PEDIATRIC PICC INSERTION TRAY , Model Number CVI4450B; h) CENTRAL LINE INSERTION TRAY , Model Number DT19810; i) NEONATAL PICC INSERTION TRAY , Model Number DYNDA2509A; j) USG PIV KIT , Model Number DYNDV2536; k) ULTRASOUND GUIDED IV START KIT , Model Number DYNDV2547; l) USG PIV KIT , Model Number DYNDV2567; m) POLY MIDLINE KIT 4F SL , Model Number DYNJ68937A; n) PICC KIT 4F SL PL MAX BARRIER , Model Number DYNJ70141MB; o) PICC KIT 5F DL PL MB , Model Number DYNJ70152MB; p) MIDLINE KIT 4F SL PL MAX BARR , Model Number DYNJ80141MB; q) MIDLINE KIT 5F DL PL MAX BARR , Model Number DYNJ80152MB; r) ULTRASOUND GUIDED PIV KIT , Model Number IVS3420B; s) ULTRASOUND GUIDED PIV INSERTION KIT , Model Number IVS3635C; t) FLOOR ULTRASOUND GUIDED IV SECUREMENT , Model Number IVS3770; u) ULTRASOUND GUIDED PIV KIT , Model Number IVS3900A; v) ULTRASOUND GUIDED PIV INSERTION KIT , Model Number IVS3940A; w) ULTRASOUND GUIDED PIV INSERTION KIT , Model Number IVS3940B; x) ULTRASOUND GUIDED PIV KIT , Model Number IVS4005; y) MIDLINE KIT 4F SL MB , Model Number MID0001; z) MIDLINE KIT 4F SL PL MAX BARR , Model Number MID0003; aa) MIDLINE BUNDLE 4FR SL , Model Number MID0005; bb) MIDLINE KIT 4F SL PL MB , Model Number PICC0009A; cc) PICC KIT 4F SL PL MAX BARRIER , Model Number PICC0010; dd) PICC KIT 4F SL PL MAX BARRIER , Model Number PICC0011; ee) PICC KIT 4F SL PL MAX BARRIER , Model Number PICC0012; ff) PICC BUNDLE 5FR DL , Model Number PICC0013; gg) VANTEX 7FR 3L 20CM CVC INSERTION BNDL , Model Number STCVC2015A; hh) VANTEX 7FR 3L 16CM CVC INSERTION BNDL , Model Number STCVC2020A;
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 26, 2023
Centurion IVS3505 ULTRASOUND GUIDED PIV KIT
FDA Enforcement
Class II
·Terminated·Centurion Medical Products Corporation·February 12, 2020
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CENTRAL CATHETER INSERTION TRAY, Model Number: CVI680C; b. CVC INSERTION ACCESSORY KIT, Model Number: ECVC7880; c. CVL INSERTION TRAY, Model Number: DYNDC1786A; d. ULTASOUND GUIDED PIV INSERTION, Model Number: IVS3635B; e. USG PIV INSERTION KIT, Model Number: DYNDV2480A;
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·August 9, 2023
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BLOCK SUPPLIES NDL CNTR, Model Number DYNJRA1755; b) VNUS TEST KIT CFP-LF, Model Number DYNJTESTCFP4; c) ULTRASOUND PIV BUNDLE, Model Number IV8635D; d) ULTRASOUND GUIDED PIV KIT, Model Number IVS3300; e) ULTRASOUND GUIDED PIV INSERTIO, Model Number IVS3485A; f) EPIV PROCEDURE TRAY, Model Number IVS3825; g) ULTRASOUND GUIDED PIV INSERTIO, Model Number IVS3840A; h) RADIOLOGY TRAY, Model Number MNS11625; i) BEDSIDE PROCEDURE PREP KIT, Model Number MNS7695A; j) NGHS EVOR ANGIO PACK, Model Number NG410A; k) PICC INSERT KIT-LESS THAN 3 FR, Model Number PHS41739A; l) RADIOLOGY SPECIALS PACK, Model Number PHS479840M; m) HYBRID OR PACK, Model Number SYNJ10303B; n) TVS4500 MULTI PURPOSE VEIN, Model Number TVS4500A; o) TVS4500 MULTI PURPOSE VEIN, Model Number TVS4500B; p) VC PROCEDURE KIT, Model Number VC-PK
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 26, 2023
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ADULT EPIV INSERTION TRAY, Model Number: DYNDA2482; b. ARTERIAL LINE START KIT, Model Number: ART920; c. CENTRAL LINE INSERTION TRAY, Model Number: DT19810; d. ECMO INSERTION BUNDLE W/O CANNULA, Model Number: CVI4915; e. FLOOR ULTRASOUND GUIDED IV SECUREMENT, Model Number: IVS3770; f. IV SECUREMENT KIT, Model Number: DYNDV2407A; g. MIDLINE BUNDLE 4FR SL, Model Number: MID0005; h. MIDLINE INSERTION TRAY, Model Number: CVI4340; i. MIDLINE KIT 4F SL MAX BARRIER STD, Model Number: MIDST04011; j. MIDLINE KIT 4F SL MB, Model Number: MID0001; k. MIDLINE KIT 4F SL PL MAX BARR, Model Number: DYNJ80141MB, MID0003; l. MIDLINE KIT 4F SL PL MB, Model Number: PICC0009A; m. MIDLINE KIT 5F DL PL MAX BARR, Model Number: DYNJ80152MB; n. NEONATAL PICC INSERTION TRAY, Model Number: DYNDA2509A, MNS8765; o. NEONATAL PICC LINE INSERTION TRAY, Model Number: DYNDC2120B; p. NICU PICC TRAY, Model Number: CVI3740A; q. PED ULTRASOUND GUIDED PIV, Model Number: IVS3990; r. PEDIATRIC PICC INSERTION TRAY, Model Number: CVI4450B; s. PERIPHERAL ULTRASOUND CATHETER INSERTION, Model Number: DYNDV2285, MNS9865; t. PICC BUNDLE 5FR DL, Model Number: PICC0013; u. PICC INSERTION BUNDLE, Model Number: DT14560; v. PICC INSERTION TRAY, Model Number: CVI3805, CVI3820; w. PICC KIT 4F SL PL MAX BARRIER, Model Number: DYNJ70141MB, PICC0010, PICC0011, PICC0012; x. PICC KIT 5F DL PL MB, Model Number: DYNJ70152MB; y. PIV BSI KIT, Model Number: BSIPIV1010; z. PIV KIT, Model Number: BSIPIV1004; aa. POLY MIDLINE KIT 4F SL, Model Number: DYNJ68937A; bb. QUINTEN CATH ACCESSORY KIT, Model Number: CVI3700; cc. ULTRASOUND GUIDED IV KIT, Model Number: IVS3705, IVS3705A, IVS3905A; dd. ULTRASOUND GUIDED IV SECUREMENT SET, Model Number: IVS3350; ee. ULTRASOUND GUIDED IV START KIT, Model Number: DYNDV2465, DYNDV2518, DYNDV2547; ff. ULTRASOUND GUIDED IV START KIT W/SHIELD, Model Number: BSIPIV1006; gg. ULTRASOUND GUIDED IV/MIDLINE KIT, Model Number: DYNDV2385; hh. ULTRASOUND GUIDED PIV, Model Number: IVS4075; ii. ULTRASOUND GUIDED PIV BUNDLE W/CHG DRSG, Model Number: BSIPIV1011; jj. ULTRASOUND GUIDED PIV INSERTION KIT, Model Number: IVS3485A, IVS3840, IVS3840A, IVS3940, IVS3940A, IVS3940B; kk. ULTRASOUND GUIDED PIV KIT, Model Number: BSIPIV1005, DYNDA2669, IVS3300, IVS3420A, IVS3420B, IVS3495, IVS3505, IVS3655B, IVS3900, IVS3900A, IVS4005; ll. ULTRASOUND GUIDED PIV START KIT, Model Number: IVS3715; mm. ULTRASOUND IV START KIT, Model Number: IV8790; nn. ULTRASOUND PIV BUNDLE, Model Number: IV8635A, IV8635B, IV8635C; oo. ULTRASOUND PIV KIT, Model Number: IVS3970; pp. UNIVERSAL BUNDLE-CENTRAL LINE PACK, Model Number: CVI3910; qq. UNIVERSAL LINE INSERTION TRAY, Model Number: DT16125; rr. USG IV START KIT, Model Number: DYNDV2435; ss. USG PIV KIT, Model Number: DYNDV2536, DYNDV2567; tt. USGPIV Insertion Kit, Model Number: MBSIULSGD01; uu. USGPIV KIT, Model Number: DYNDV2578; vv. USPIV KIT, Model Number: IVS3910; ww. VAMC PICC PREP BUNDLE, Model Number: CVI3880; xx. VANTEX 7FR 3L 16CM CVC INSERTION BNDL, Model Number: STCVC2020A; yy. VANTEX 7FR 3L 20CM CVC INSERTION BNDL, Model Number: STCVC2015A; zz. VI PACK, Model Number: DYNJ64871
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·August 9, 2023
Medline Convenience kits, labeled as: 1) TRACHEOTOMY TRAY, Pack Number DYNDA1894; 2) ULTRASOUND GUIDED PIV KIT, Pack Number MNS9580;
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024
LW Scientific ZIP IQ PCV Centrifuge, ZIC-24HD-75T3 Rev C Product Usage: used as a general purpose centrifuge to spin down blood in hematocrit tubes
FDA Enforcement
Class II
·Terminated·LW Scientific, Inc.·April 3, 2019
BD BBL BCYE Selective Agar with PAV, Catalog # 297880, packaged in cartons of 10 plates, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** BCYE Selective with PAV is used in qualitative procedures for isolation of Legionella species from clinical specimen and nonclinical (environmental) samples. It is similar to the Edelstein formula, except that the concentration of polymyxin B is reduced by half, and vancomycin is substituted for cefamandole.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·July 31, 2013
NEEDLEMASTER 6MMx 25G UPPER, model no. NM-610L-0625 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
FDA Enforcement
Class II
·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021
NEEDLEMASTER 4MMx 21G UPPER, model no. NM-610L-0421 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
FDA Enforcement
Class II
·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021
B-V443Q-A 3-LUMEN EXTRACTION BALLOON V, model no. B-V443Q-A - Product Usage: Used with endoscopes to endoscopically remove stones such as calculi, pancreatic and common bile duct stones.
FDA Enforcement
Class II
·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021
NEEDLEMASTER 5MMx 21G UPPER, model no. NM-610L-0521 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
FDA Enforcement
Class II
·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021
NEEDLEMASTER 3MMx 23G LOWER, model no. NM-610L-0523 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
FDA Enforcement
Class II
·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021
NEEDLEMASTER 6MMx 21G UPPER, model no. NM-610L-0621 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
FDA Enforcement
Class II
·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021
NEEDLEMASTER 5MMx 25G UPPER, model no. NM-610L-0525 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
FDA Enforcement
Class II
·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021
B-V243Q-A 3-LUMEN EXTRACTION BALLOON V, model no. B-V243Q-A - Product Usage: Used with endoscopes to endoscopically remove stones such as calculi, pancreatic and common bile duct stones.
FDA Enforcement
Class II
·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021
NEEDLEMASTER 6MMx 25G LOWER, model no. NM-610U-0625 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
FDA Enforcement
Class II
·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021
B-V233P-A 3-LUMEN EXTRACTION BALLOON V, model no. B-V233P-A - Product Usage: Used with endoscopes to endoscopically remove stones such as calculi, pancreatic and common bile duct stones.
FDA Enforcement
Class II
·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021