51 results
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20ms
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Sources: EU EUDAMED, US FDA
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Sofsilk Braided Silk sutures: CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 GS-831 SOFSILK* 4-0 BLK 75CM V20 X36 S-176 SOFSILK* 0 BLK 12X45CM PCT X24 S-182 SOFSILK* 5-0 BLK 12X45CM PCT X36 S-184 SOFSILK* 3-0 BLK 12X45CM PCT X36 S-185 SOFSILK* 2-0 BLK 12X45CM PCT X36 S-245 SOFSILK* 2-0 BLK 12X60CM PCT X36 S-246 SOFSILK* 0 BLK 6X60CM PCT X36 S-2782K SOFSILK* 4-0 WHI 45CM SS24 DA S-303 SOFSILK* 4-0 BLK 12X75CM PCT X36 S-304 SOFSILK* 3-0 BLK 12X75CM PCT X36 S-305 SOFSILK* 2-0 BLK 12X75CM PCT X36 S-316 SOFSILK* 0 BLK 12X75CM PCT X24 S-317 SOFSILK* 1 BLK 12X75CM PCT X24 S-605 SOFSILK* 2-0 BLK 2X150CM PCT X36 S-606 SOFSILK* 0 BLK 2X150CM PCT X36 S606-12 SOFSILK* 0 BLK 2X150CM PCT X12 S-610 SOFSILK* 5 BLK 2X150CM PCT X12 SOFSILK 2-0 30 BK CV-24 GS453-2 SOFSLK 4-0 24 BK CV-15 DA VS581-2 ***Added 4/1/24*** CS-792 SOFSILK* 0 BLK 100CM GCC90 X36 S-1172 SOFSILK* 6-0 BLK 45CM C1 X36 S-1735 SOFSILK* 4-0 BLK 30CM C1 DA X12 S-1750K SOFSILK* 6-0 BLK 45CM HE1 DAX12 S-1768K SOFSILK* 7-0 BLK 45CM HE6 DAX12 S-1789K SOFSILK* 4-0 BLK 45CM HE3 X12 S-187 SOFSILK* 1 BLK 6X45CM PCT X36 S-243 SOFSILK* 4-0 BLK 12X60CM PCT X36 S-2780K SOFSILK* 6-0 BLK 45CM SS-24DA S-282 SOFSILK* 5 BLK 3X60CM PCT X36 S-318 SOFSILK* 2 BLK 12X75CM PCT X24 S-608 SOFSILK* 2 BLK 2X150CM PCT X36 VS-872 SOFSILK* 3-0 BLK 75CM CV23 X36 VS872-2 SOFSILK 3-0 30 BK CV-23 VS872-2 SS-1694G SOFSILK 4/0 BLK 45CM P24 X12 SS-5641 SOFSILK* 4-0 BLK 45CM P13 X36 SS-5649G SOFSILK* 6-0 BLK 45CM P13 X12 SS-645 SOFSILK* 4-0 BLK 75CM C12 X36 SS-675 SOFSILK* 3-0 BLK 75CM C16 X36 SS-681 SOFSILK* 6-0 BLK 45CM C12 X36 VS-872 SOFSILK* 3-0 BLK 75CM CV23 X36 XX-5280 SOFSILK* 0 BLK 150CM PCT X36 -- Ti-Cron Coated Braided Polyester Sutures: 3087-31 TICRON* 4-0 BLU 75CM CV-331DA 3226-31 TICRON* 4-0 BLU 60CM CV330 DA 88863026-71 TICRON* 1 BLU 75CM HOS12X36 88863070-51 TICRON* 2-0 BLU 75CM C15X36 88863087-31 TICRON* 4-0 BLU 75CM CV33DA 88863092-71 TICRON* 1 BLU 75CM KV37X36 88863147-83 TICRON 2 BLU 5X75CM KV37X12 88863185-41 TICRON* 3-0 BLU 75CM CV305 88863186-31 TICRON* 4-0 BLU 75CM CV331 88863226-31 TICRON* 4-0 BLU 60CM CV330DA 88863226-41 TICRON* 3-0 BLU 60CM CV330DA 88863229-31 TICRON* 4-0 BLU 75CM CV307DA 88863271-31 TICRON* 4-0 BLU 90CM CV331DA 88863309-71 TICRON* 1 BLU 75CM GS11X36 -- Monosof Monofilament Nylon Sutures: N-63 MONOSOF* 3-0 BLK 12X45CM PCT X36 SN-3695 MONOSOF* 5-0 BLK 45CM P10 X12 -- Steel Monofilament Stainless Steel Sutures 88862224-49 STEEL 7 4X45CM SCC X12
FDA Enforcement
Class II
·Ongoing·Covidien LP·February 7, 2024
Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN3800, Lot 7JH, NDC 08470-3800-01, The product is a non-sterile automatic subcutaneous injection device which delivers insulin.
FDA Enforcement
Class II
·Terminated·Owen Mumford USA, Inc.·July 22, 2015
Medtronic Advanced Energy Aquamantys3 Pump Generator; Product Catalog Number: 10-1357 (Generator assembly), 40-404-1(as shipped, including accessories) The Aquamantys3 System combines radio frequency (RF) energy and saline to reduce blood loss during and after surgical procedures. This patented Transcollation technology has been shown to reduce transfusion rates and may also reduce the need for other blood management procedures.
FDA Enforcement
Class II
·Terminated·Medtronic Advanced Energy, LLC·February 12, 2014
Sodium Bicarbonate, USP Provided bulk as raw material - label not applicable according to firm Dialysis Grade 1.5 Dialysis Grade 2 As an API or excipient in the manufacture of Medical Devices and Drugs
FDA Enforcement
Class II
·Terminated·Church & Dwight Inc·July 31, 2013
epoc Host 2 as follows: Product SMN epoc NXS Host, US 11413475 epoc NXS Host, EU 11413497 epoc NXS Host, Japan 11413498 epoc NXS Host, Canada 11413506 epoc NXS Host, ROW 11413518 epoc NXS Host, China-Korea 11413583
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics Inc·March 15, 2023
Hemoccult ICT (Immunochemical Fecal Occult Blood Test) is a rapid, visually read, qualitative immunochemical chromatographic method for detection of human hemoglobin in fecal samples.
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·August 28, 2013
Refill 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-MM-REF18001800;
FDA Enforcement
Class II
·Ongoing·DAYE (ANNE'S DAY LTD)·November 5, 2025
18 Coated Regular Tampons; Model Number: FG-TMP-REF18000000;
FDA Enforcement
Class II
·Ongoing·DAYE (ANNE'S DAY LTD)·November 5, 2025
Initiation 36 Coated Super Tampons; Model Number: FG-TMP-MM-IB00360000;
FDA Enforcement
Class II
·Ongoing·DAYE (ANNE'S DAY LTD)·November 5, 2025
Refill 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-MM-REF00180018;
FDA Enforcement
Class II
·Ongoing·DAYE (ANNE'S DAY LTD)·November 5, 2025
Initiation 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-TMP-MM-IB18180000;
FDA Enforcement
Class II
·Ongoing·DAYE (ANNE'S DAY LTD)·November 5, 2025
Regular Flow Bundle; Model Number: FG-BNDL-PC-REFRF;
FDA Enforcement
Class II
·Ongoing·DAYE (ANNE'S DAY LTD)·November 5, 2025
9 Coated Regular and 9 Nude Regular Tampons; Model Number: FG-TMP-REF09000900;
FDA Enforcement
Class II
·Ongoing·DAYE (ANNE'S DAY LTD)·November 5, 2025
9 Coated Regular and 9 Coated Super Tampons; Model Number: FG-TMP-REF09090000;
FDA Enforcement
Class II
·Ongoing·DAYE (ANNE'S DAY LTD)·November 5, 2025
9 Coated Super and 9 Nude Super Tampons; Model Number: FG-TMP-REF00090009;
FDA Enforcement
Class II
·Ongoing·DAYE (ANNE'S DAY LTD)·November 5, 2025
18 Coated Super Tampons; Model Number: FG-TMP-REF00180000;
FDA Enforcement
Class II
·Ongoing·DAYE (ANNE'S DAY LTD)·November 5, 2025
Initiation 36 Coated Regular Tampons; Model Number: FG-TMP-MM-IB36000000;
FDA Enforcement
Class II
·Ongoing·DAYE (ANNE'S DAY LTD)·November 5, 2025
Initiation 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-IBAIO;
FDA Enforcement
Class II
·Ongoing·DAYE (ANNE'S DAY LTD)·November 5, 2025
Initiation 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-IBRF;
FDA Enforcement
Class II
·Ongoing·DAYE (ANNE'S DAY LTD)·November 5, 2025
Initiation 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-MM-IB18001800;
FDA Enforcement
Class II
·Ongoing·DAYE (ANNE'S DAY LTD)·November 5, 2025