Mani, Inc. (Head Office)
UTSUNOMIYA Tochigi, JP
MANI, INC. (HEAD OFFICE) appears in FDA device records in UTSUNOMIYA Tochigi, JP. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 9 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Mani, Inc. (Head Office) carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Mani, Inc. - Kiyohara Facilityenforcement report, recall
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3002692886 | 3002692886 | MANI, INC. (HEAD OFFICE) | 8-3, KIYOHARA INDUSTRIAL PARK,, UTSUNOMIYA Tochigi 321-3231 JP | 2026 | and 10 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GESBlade, Scalpel
- EKWBroach, Endodontic
- EJLBur, Dental
- NGYCannula, Trocar, Ophthalmic
- DZADrill, Dental, Intraoral
- EKSFile, Pulp Canal, Endodontic
- HNRForceps, Ophthalmic
- DZPInstrument, Diamond, Dental
- KTGKnife, Ent
- HNNKnife, Ophthalmic
- GDLNeedle, Suturing, Reusable
- PAWNonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement
- EKRPlugger, Root Canal, Endodontic
- EKPReamer, Pulp Canal, Endodontic
- EKKSpreader, Pulp Canal Filling Material, Endodontic
- GDTStaple, Removable (Skin)
- GAMSuture, Absorbable, Synthetic, Polyglycolic Acid
- GAPSuture, Nonabsorbable, Silk
- GARSuture, Nonabsorbable, Synthetic, Polyamide
- GATSuture, Nonabsorbable, Synthetic, Polyethylene
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1468-2023 | Mani Trocar Kit, Model MTK23S and Model MTK25S There are 3 kits contained in one box, and sterile 1 kit consists of 3 pcs. trocar with the valved cannula and 1 pc. infusion cannula. | A packaging defect may compromise the sterile barrier. | Class II | Terminated | |
| Z-0558-2021 | MANI Infusion Cannula 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during ophthalmic surgery Ref: MTC 23S | Dimensions of the Luer connector parts out of specification, may cause leakage of fluid and unintended disconnection during use | Class II | Terminated | |
| Z-0557-2021 | MANI TROCAR KIT 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during ophthalmic surgery, Ref: MTK 23S | Dimensions of the Luer connector parts out of specification, may cause leakage of fluid and unintended disconnection during use | Class II | Terminated | |
| Z-0654-2012 | MANI Needle and Suture Pack, 5-0 PGA Absorbable, Model 3391, 45 cm suture and needle, packaged in individual aluminum pack, within tyvek packaging, 12 packages per box, and labeled in part ***Mani, Inc 8-3 Kiyohara Industrial Park Utsunomiya, Tochigi, Japan*** For use in short term soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue. | Surgical sutures may be weak and may not function as intended during surgical procedures. | Terminated | ||
| Z-0653-2012 | MANI Needle and Suture Pack, 6-0 PGA Absorbable, Model 2890, 45 cm suture and needle, packaged in individual aluminum pack, within tyvek packaging, 12 packages per box, and labeled in part ***Mani, Inc 8-3 Kiyohara Industrial Park Utsunomiya, Tochigi, Japan*** For use in short term soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue. | Surgical sutures may be weak and may not function as intended during surgical procedures. | Terminated | ||
| Z-0652-2012 | MANI Needle and Suture Pack, 6-0 PGA Absorbable, Model 2490, 45 cm suture and needle, packaged in individual aluminum pack, within tyvek packaging, 12 packages per box, and labeled in part ***Mani, Inc 8-3 Kiyohara Industrial Park Utsunomiya, Tochigi, Japan*** For use in short term soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue. | Surgical sutures may be weak and may not function as intended during surgical procedures. | Terminated | ||
| Z-0651-2012 | MANI Needle and Suture Pack, 7-0 PGA Absorbable, Model 2092, 45 cm suture and needle, packaged in individual aluminum pack, within tyvek packaging, 12 packages per box, and labeled in part ***Mani, Inc 8-3 Kiyohara Industrial Park Utsunomiya, Tochigi, Japan*** For use in short term soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue. | Surgical sutures may be weak and may not function as intended during surgical procedures. | Terminated | ||
| Z-0650-2012 | MANI Needle and Suture Pack, 7-0 PGA Absorbable, Model 2091, 30 cm suture and needle, packaged in individual aluminum pack, within tyvek packaging, 12 packages per box, and labeled in part ***Mani, Inc 8-3 Kiyohara Industrial Park Utsunomiya, Tochigi, Japan*** For use in short term soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue. | Surgical sutures may be weak and may not function as intended during surgical procedures. | Terminated | ||
| Z-0649-2012 | MANI Needle and Suture Pack, 8-0 PGA Absorbable, Model 2090, 30 cm suture and needle, packaged in individual aluminum pack, within tyvek packaging, 12 packages per box, and labeled in part ***Mani, Inc 8-3 Kiyohara Industrial Park Utsunomiya, Tochigi, Japan*** For use in short term soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue. | Surgical sutures may be weak and may not function as intended during surgical procedures. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain