Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 5 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Merit Medical Systems and its 3 subsidiaries with 194 510(k) clearances, 146 device recalls and 1 drug recall. The most recent is a device recall dated Aug 27, 2026: Scout MD, REF MDS05A-01, MDS05C-01, MDS10C-01 Contents: (1) Scout MD Delivery System, ….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Merit Medical Systems and its 3 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Aug 27, 2026 | Scout MD, REF MDS05A-01, MDS05C-01, MDS10C-01 Contents: (1) Scout MD Delivery System, Standard for use with the SCOUT MD Surgical GuidanceClass II · The implantable clip may experience difficulties deploying, which could prevent the reflector from functioning as intend | Device recalls |
| Aug 10, 2026 | Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam, REF: S420GH/EUA, S620GH/EUA; Embosphere 700-900 micrometer 2 mL Syringe SteriClass II · Microspheres used in embolization of tumors, prostatic arteries, arteriovenous malformations, and blood vessels may have | Device recalls |
| Jul 27, 2026 | FlexTract Deflectable-Rotational Dilator Sheath SetK261310 · DRE | 510(k) clearances |
| Jul 22, 2026 | PreludeSYNC™ Radial Compression DeviceK262086 · DXC | 510(k) clearances |
| Jul 13, 2026 | Merit MAK Nitinol/Gold-Tungsten Guide WireK261640 · DQX | 510(k) clearances |
| May 22, 2026 | InQwire Amplatz Guide WireK254137 · DQX | 510(k) clearances |
| May 13, 2026 | StatSeal DiscK254073 · FRO | 510(k) clearances |
| May 8, 2026 | Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes: 00884450529645 00884450529669 00884450529690 REF: MSWSTDA35180 UClass II · Due to unsealed portions of pouches. | Device recalls |
| Apr 2, 2026 | Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLYClass II · catheter may experience resistance when being advanced over the guidewire | Device recalls |
| Apr 2, 2026 | Philips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLYClass II · catheter may experience resistance when being advanced over the guidewire | Device recalls |
| Apr 2, 2026 | Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLYClass II · catheter may experience resistance when being advanced over the guidewire | Device recalls |
| Feb 13, 2026 | STAR RF Ablation SystemK251802 · GXI | 510(k) clearances |
| Feb 13, 2026 | CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, CENFP31K/A, CENFT15K, CENFT1Class I · 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemo | Device recalls |
| Feb 13, 2026 | ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C, DC21455550/CClass I · 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemo | Device recalls |
| Jan 31, 2026 | Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)K253847 · DQX | 510(k) clearances |
| Jan 21, 2026 | InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S)K251385 · DQX | 510(k) clearances |
| Feb 24, 2006 | Merit Convenience Kits containing Cytosol Ophthalmics Balanced Salt Solution, 18 mL Single Dose Bottle, NDC 23731-8100-8, Sterile.Class I · Lack of Assurance of Sterility: Procedure kits contain a balanced salt solution that may be contaminated with endotoxins | Drug recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
