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APPLIED LAP KIT #1

APPLIED MEDICAL RESOURCES CORPORATION · Model K2266 · UDI-DI 30607915128372

GCJFZPMDM Prescription
10
510(k) clearances
84,092
Adverse events (262 deaths)
274
Recalls
570
Facilities

Description

Kit Contains: CTR03, 5x100 Kii® OPT ZTHR 6/BX CTR73 12X100 Kii® OPT ZTHR 6/BX CTS22, 12x100 Kii® SLEEVE ZTHR 12/BX C2201, 120MM INSUFF NEEDLE XE, 20/BX CA500, EPIX® UNIVERSAL CLIP APPLIER 3/BX CTS02, 5x100 Kii® SLEEVE ZTHR 12/BX

Recalls

DateFirmReason
2026-07-07Olympus Corporation of the AmericasPotential for the HDMI and DisplayPort (DP) connectors can become faulty resulting in image loss or image abnormalities.
2025-12-11Applied Medical Resources CorpThere is the potential for extended length of the blade obturator after assembly into the cannula and seal housing.
2025-09-24Aesculap IncIt was determined there is the potential of silicone fragments detaching from the yellow sealing component.
2025-09-24Aesculap IncIt was determined there is the potential of silicone fragments detaching from the yellow sealing component.
2025-09-24Aesculap IncIt was determined there is the potential of silicone fragments detaching from the yellow sealing component.
2025-09-24Aesculap IncIt was determined there is the potential of silicone fragments detaching from the yellow sealing component.
2025-06-18Stryker CorporationDue to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction.
2024-06-25UNIMAX MEDICAL SYSTEMS INCThe tube may fall into the surgical site during the grasping process.
2024-06-11Canadian Hospital Specialties Ltd.A customer found product with incomplete seals of P/N 20400161S, lot #185198 which can lead to non-sterile product and patient safety concerns. CHS has validated this complaint.
2024-06-03ASPEN SURGICALThe affected products may have been packaged with a defect in the sterile barrier seal. As a result, the integrity of the sterile barrier may be compromised.

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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.