Data / Medical devices / United States / Terumo Medical Corp.
Terumo Medical Corp.: FDA-registered device maker in Somerset, NJ, United States, 1 PMA approval
Terumo Medical Corp. is registered with the FDA (registration 2243441) in Somerset, NJ, United States. It lists 1 device type. The FDA files 1 PMA approval under its listings, the newest dated September 30, 1996. 4 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2243441
- Address
- 265 Davidson Ave Suite 320, Somerset, NJ, United States, 08873
- Owner or operator
- TERUMO MEDICAL CORP. (9003933)
- Roles
- Manufacturer for export, Specification developer
- First device listed
- January 25, 2017
- Registered through
- 2027
- Brand names listed
- Angio-Seal, Angio-Seal VIP Vascular Closure Device, FemoSeal
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Hemostasis, Vascular | MGB | 3 | Manufacturer for export, Specification developer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| September 30, 1996 | P930038 | Angio Seal Vascular Closure Device | MGB | 99 | August 4, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 9, 2018 | 80242 | Class II | Terminated | Angio-Seal Evolution Vascular Closure Device, Cat. No. C610135 | Two lots of product were released for distribution prior to the completion of all required validation and lot acceptance activities. Although sterile, products from these lots may not function as intended and therefore should not be used. | accessdata.fda.gov |
| June 7, 2017 | 77661 | Class II | Terminated | Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.021), REF/Product Code RM*CS5F10NA, STERILE, Rx ONLY | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath. | accessdata.fda.gov |
| August 4, 2016 | 75370 | Class II | Terminated | MISAGO RX Self Expanding Peripheral Stem | During recent routine testing, the MISAGO Peripheral Stent was found not to conform to product specification related to stent diameter at the proximal/distal ends and/or the shape of the stent. | accessdata.fda.gov |
| November 23, 2015 | 72828 | Class II | Terminated | Terumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshield), Product Code: SV-S25FL35. | Potential improper bonding between the tube and luer for certain lots of Surflo Winged Infusion Set with Filter and Needle Protection (Surshield). | accessdata.fda.gov |
Compare with other makers
Updated August 4, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.