Home › Device types › LRC
Instrument, Ent Manual Surgical
FDA product code LRC · Class 1 · Ear, Nose, Throat
8,384
Registered devices
563
Adverse events
5
Recalls
65
510(k) clearances
Devices with this code
FENTEX — FENTEX medical GmbHMicro ear forceps — Spiggle & Theis Medizintechnik GmbHn.a. — Karl Storz GmbH & Co. KGELMED — ELMED INCORPORATEDMillennium — Avalign Technologies, Inc.Castroviejo micro needle holder — Spiggle & Theis Medizintechnik GmbHn.a. — Karl Storz GmbH & Co. KGRZ Medizintechnik GmbH — RZ-Medizintechnik GmbHELMED — ELMED INCORPORATEDXprESS Pro — STRYKER CORPORATIONHartmann cutting forceps — Spiggle & Theis Medizintechnik GmbHSurtex — SURTEX INSTRUMENTS LTD.RZ Medizintechnik GmbH — RZ-Medizintechnik GmbHFENTEX — FENTEX medical GmbHn.a. — Karl Storz GmbH & Co. KGELMED INCORPORATED — ELMED INCORPORATEDSymmetry Surgical — ASPEN SURGICAL PRODUCTS, INC.Micro laryngeal forceps — Spiggle & Theis Medizintechnik GmbHFENTEX — FENTEX medical GmbHFENTEX — FENTEX medical GmbHn.a. — Karl Storz GmbH & Co. KGn.a. — Karl Storz GmbH & Co. KGRZ Medizintechnik GmbH — RZ-Medizintechnik GmbHn.a. — Karl Storz GmbH & Co. KG
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-12-19 | Karl Storz Endoscopy | Due to failure of manual cleaning validation, biopsy and grasping forceps like sterility assurance. |
| 2024-02-27 | Karl Storz Endoscopy | Inadequate reprocessing validation evidence |
| 2023-10-24 | Karl Storz Endoscopy | The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if use |
| 2013-05-24 | Gyrus Acmi, Incorporated | lack of sterility assurance |
| 2006-01-20 | Acclarent Inc | Device sterility may be compromised as evidenced by a loss of package integrity. |
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