Surgical Specialties Mexico S de RL de CV
Tijuana Baja California, MX
Surgical Specialties Mexico S DE RL DE CV appears in FDA device records in Tijuana Baja California, MX. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
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 |
|---|---|---|---|---|---|
| 3010692967 | 3010692967 | Surgical Specialties Mexico S DE RL DE CV | Corredor Tijuana - Rosarito 2000-24702 B, Tijuana Baja California 22235 MX | 2026 | and 13 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NBHAccessories, Arthroscopic
- HRXArthroscope
- GESBlade, Scalpel
- GEJCarrier, Ligature
- FODDevice, Occlusion, Umbilical
- MBIFastener, Fixation, Nondegradable, Soft Tissue
- HNNKnife, Ophthalmic
- EMFKnife, Surgical
- HASNeedle, Neurosurgical Suture
- GABNeedle, Suturing, Disposable
- GDLNeedle, Suturing, Reusable
- KBRNeedle, Tonsil Suturing
- LZUPlug, Punctum
- GALSuture, Absorbable, Natural
- GAMSuture, Absorbable, Synthetic, Polyglycolic Acid
- GAPSuture, Nonabsorbable, Silk
- GAQSuture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
- GARSuture, Nonabsorbable, Synthetic, Polyamide
- GATSuture, Nonabsorbable, Synthetic, Polyethylene
- GAWSuture, Nonabsorbable, Synthetic, Polypropylene
- NEWSuture, Surgical, Absorbable, Polydioxanone
- NBYSuture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
- MTJWax, Bone
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0068-2017 | BioSentry Tract Sealant System, Product Code: 768022019S; Indicated to provide accuracy in marking a biopsy location for visualization during surgical resection. | Surgical Specialties Mexico is recalling the BioSentry Track Sealant System due to the potential for an open seal on the product package. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain
