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Surgiform
SURGICAL TECHNOLOGY LABORATORIES INC · Model SB-03 · UDI-DI 00851988007907
MIB
Prescription
1
510(k) clearances
187
Adverse events
3
Recalls
11
Facilities
Description
"SB-03 Silicone Block - Size Three - Med Duro-Clear"
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-09-26 | DSAART LLC | Manufactured products deviated from established specifications and were distributed without obtaining the required FDA premarket approvals or clearances. |
| 2025-09-26 | DSAART LLC | Manufactured products deviated from established specifications and were distributed without obtaining the required FDA premarket approvals or clearances. |
| 2025-09-26 | DSAART LLC | Manufactured products deviated from established specifications and were distributed without obtaining the required FDA premarket approvals or clearances. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.