Chrysalis Intelligence · Sponsors · Applied Medical Resources Corporation

Applied Medical Resources Corporation

Rancho Santa, CA, US · 14 510(k) clearances · 11 recalls

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Total clearances
14
2020-04-08 → 2026-04-24
Last 12 months
6
Product codes
7
Most recent
2026-04-24
Name variants in FDA filings: Applied Medical Resources Corporation / Applied Medical Resources Corp. / Applied Medical Resources
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
GEI Electrosurgical, Cutting & Coagulation & Accessories Class II General, Plastic Surgery 5 2025-11-04
GCJ Laparoscope, General & Plastic Surgery Class II Gastroenterology, Urology 3 2025-10-31
KGW Ring (Wound Protector), Drape Retention, Internal Class II General, Plastic Surgery 2 2026-04-24
HEW Culdoscope (And Accessories) Class II Obstetrics/Gynecology 1 2025-10-02
MOK — — — 1 2022-09-16
DXE — — — 1 2021-09-07
FER Anoscope And Accessories Class II Gastroenterology, Urology 1 2021-01-06
Safety

Recalls (11)

Class I (serious)
0
Risk of injury / death
Total recalls
11
Currently ongoing
3
Most recent
2025-12-11
DateSeverityStatusRecall # ProductCodeReason
2025-12-11 Class II Ongoing Z-1010-2026 Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23 — There is the potential for extended length of the blade obturator after assembly into the cannula and seal housing.
2024-01-30 Class II Ongoing Z-1389-2024 Epix Universal Clip Applier, REF: CA500, STERILEEO included within the following kit Reference Numbers: GK1003, AME Kit… — Their is the potential that Universal Clip applier may not load clip after the trigger is actuated.
2024-01-30 Class II Ongoing Z-1388-2024 Epix Universal Clip Applier, REF: CA500, STERILEEO — Their is the potential that Universal Clip applier may not load clip after the trigger is actuated.
2020-03-17 Class II Terminated Z-2161-2020 Clip Applier Kit, REF: K2887, UDI: (01)30607915139132(17)220822(30)1(10) — There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to …
2020-03-17 Class II Terminated Z-2160-2020 DR. THAMES - LAP CHOLE, REF: K0880, UDI: (01)30607915139620 — There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to …
2020-03-17 Class II Terminated Z-2159-2020 Epix latis GRASPER, 5mm x 45 cm, REF: C4140, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110154 — There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to …
2020-03-17 Class II Terminated Z-2158-2020 Epix latis GRASPER, 5 mm x 35 cm, REF C4130, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110147 — There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to …
2020-01-31 Class II Terminated Z-2037-2020 STEALTH SPRING CLIP 6mm latis (1/4 Force). Non-Sterile, REF/UDI::A1702/(01)10607915110649 - Product Usage: The device is… — Failure of cardiovascular clips to provide sufficient occlusion of the vessel.
2020-01-31 Class II Terminated Z-2036-2020 STEALTH SPRING CLIP 6mm latis (3/4 Force). REF/UDI::A1603/(01)00607915110581 - Product Usage: The device is indicated fo… — Failure of cardiovascular clips to provide sufficient occlusion of the vessel.
2020-01-31 Class II Terminated Z-2035-2020 STEALTH SPRING CLIP 6mm latis (1/4 Force). REF/UDI::A1602/(01)00607915110574 - Product Usage: The device is indicated fo… — Failure of cardiovascular clips to provide sufficient occlusion of the vessel.
2020-01-31 Class II Terminated Z-2034-2020 STEALTH SPRING CLIP 6mm latis (1/2 Force). REF/UDI::A1601/(01)00607915110567 - Product Usage: The device is indicated fo… — Failure of cardiovascular clips to provide sufficient occlusion of the vessel.
Filings

All 510(k) clearances (14)

Date K-number Device Code Class Specialty
2026-04-24 K260982 Alexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis lighted wound protector-retractor, flexible, small (cl301);Alexis lighted wound protector-retractor, flexible, medium (cl302);Alexis lighted wound protector-retractor, flexible, large (cl303);Alexis lighted wound protector-retractor, rigid, small (cl401);Alexis lighted wound protector-retractor, rigid, medium (cl402); Alexis lighted wound protector-retractor, rigid, large (cl403) KGW Class II General, Plastic Surgery
2026-02-23 K253531 Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302) KGW Class II General, Plastic Surgery
2025-11-04 K252740 Voyant® Open Fusion Device (EB240/Open Fusion) GEI Class II General, Plastic Surgery
2025-10-31 K252442 Kii Structural Balloon Access System GCJ Class II Gastroenterology, Urology
2025-10-31 K252412 Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator) GEI Class II General, Plastic Surgery
2025-10-02 K243152 GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device HEW Class II Obstetrics/Gynecology
2023-11-01 K232880 Inzii Ripstop Redeployable Retrieval System GCJ Class II Gastroenterology, Urology
2022-10-14 K222284 Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214) GEI Class II General, Plastic Surgery
2022-09-16 K220969 GelPOINT V-Path Vaginal Access System MOK — —
2022-03-31 K211043 Alexis Contained Extraction System GCJ Class II Gastroenterology, Urology
2021-09-07 K202049 Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter DXE — —
2021-01-06 K200021 Applied Medical Anoscope FER Class II Gastroenterology, Urology
2020-06-05 K201212 Voyant Open Fusion Device GEI Class II General, Plastic Surgery
2020-04-08 K200598 Voyant Maryland Fusion Device GEI Class II General, Plastic Surgery
Data source: openFDA · Generated 2026-08-28 09:16 · Last ingest 2026-08-28T13:16:47.116226 · Pipeline: Chrysalis Intelligence