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Specula Accessories

FDA product code FXG · Class 1 · General, Plastic Surgery

46
Registered devices
4
Adverse events
1
Recalls
1
510(k) clearances

Devices with this code

Ear funnel, grey, large Ø 4.0 mm, 10x100 pcs. in polybag — Kirchner & Wilhelm GmbH + Co KGBV Medical — BV MedicalBV Medical — BV MedicalBV Medical — BV MedicalKaWe — BV MedicalKaWe — BV MedicalMicroFrance® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONIntegra® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONREALSTAR SURGICAL INSTRUMENTS — REAL STAR SURGICAL INSTRUMENTSAmbler Surgical — AMBLER SURGICAL CORP.Ear funnel, black, large Ø 4.0 mm, in units of 100 pcs. — Kirchner & Wilhelm GmbH + Co KGEar funnel, black, small Ø 2.5 mm, in units of 100 pcs. — Kirchner & Wilhelm GmbH + Co KGEar funnel, small, grey, Ø 2.5 mm, 10 x 100 pcs. in carton — Kirchner & Wilhelm GmbH + Co KGNovo Surgical Inc. — NOVO SURGICAL, INC.BV Medical — BV MedicalBV Medical — BV MedicalBV Medical — BV MedicalKaWe — BV MedicalOcular Exam Neonatal Speculum — Neotech Products LLCMillennium — Avalign Technologies, Inc.AESCULAP — AESCULAP, INC.KaWe — BV MedicalBR Surgical, LLC — BR Surgical, LLCOcular Exam Standard Speculum — Neotech Products LLC

Recent recalls

DateFirmReason
2022-02-28Integra LifeSciences Corp.Excess force used to tighten the Universal Flexible Arm can cause the internal cable to break at the tip, resulting in an unusable condition.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.