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Snowden-Pencer

STERIS CORPORATION · Model 88-9724 · UDI-DI 10885403155178

FST Prescription
1
510(k) clearances
312
Adverse events
12
Recalls
75
Facilities

Description

Snowden-Pencer MIS SNOWDEN-PENCER FIBEROPTIC LIGHT CABLE STORZ/ACMI 5.0MM X 7.5FT

Recalls

DateFirmReason
2014-11-26Steris CorporationSTERIS has learned that groups of LED lights (modules) contained within the vLED light head may illuminate inconsistently.
2012-04-09Gulf Fiberoptics, Inc.The GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink falls outside of the firm's 510k due to light transmitting fiber material difference.
2011-10-10Integra LifeSciences Corp.Headlight assembly (module) may become loose and separate from the headband assembly
2011-10-10Integra LifeSciences Corp.Headlight assembly (module) may become loose and separate from the headband assembly
2011-10-10Integra LifeSciences Corp.Headlight assembly (module) may become loose and separate from the headband assembly
2011-10-10Integra LifeSciences Corp.Headlight assembly (module) may become loose and separate from the headband assembly
2011-10-10Integra LifeSciences Corp.Headlight assembly (module) may become loose and separate from the headband assembly
2011-10-10Integra LifeSciences Corp.Headlight assembly (module) may become loose and separate from the headband assembly
2011-10-10Integra LifeSciences Corp.Headlight assembly (module) may become loose and separate from the headband assembly
2011-10-10Integra LifeSciences Corp.Headlight assembly (module) may become loose and separate from the headband assembly

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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.