FDA Device Intelligence
Home › SONTEC INSTRUMENTS, INC. › ST MARKS HAND RETRACTOR

ST MARKS HAND RETRACTOR

SONTEC INSTRUMENTS, INC. · Model 508-325L · UDI-DI 00192896044401

FDG Prescription
2
510(k) clearances
89
Adverse events
2
Recalls
76
Facilities

Description

ST MARKS HAND RETRACTOR WITH LIP AND FIBER OPTIC LIGHT CARRIER/UNIVERSAL CONNECTOR TAPERS TO 3.5 CM ANGLED TIP

Recalls

DateFirmReason
2009-07-01Lumitex IncAdhesive which is used to attach LightMat to retractor may not have been tested to Medical standards. The vendor provided an adhesive strip that did not conform to Lumitex specifi
2008-10-24Biomet Microfixation, Inc.Fiber optic cable is missing from the Frederick's Converse Retractor Lot # 042408D08.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data 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.