Applied Medical Resources Corp.
Applied Medical Resources Corp. holds FDA 510(k) medical device clearances, first cleared 2001, most recent 2025, with 30 FDA device recalls on record.
Top product codes for Applied Medical Resources Corp.
FDA recalls by Applied Medical Resources Corp.
10 most recent of 30- Z-1010-2026 — Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23
- Z-1388-2024 — Epix Universal Clip Applier, REF: CA500, STERILEEO
- Z-1389-2024 — Epix Universal Clip Applier, REF: CA500, STERILEEO included within the following kit Reference Numbers: GK1003, AME Kit 54562 GK1004, KIT LAP CHOL DEN HOED 2, GK1005, K2550 - H¿PATECTOMIE ERASME, GK1011, K-19459, GK1014, K-18031 STANDARD KIT, GK1018, K-20735 STANDARD KIT, GK1033, AME STANDARD KIT 21-023, GK1044, KE39830 COLE, GK1047, AME STANDARD KIT 22-003, GK1063, AME STANDARD KIT 22-022, GK1068, AME STANDARD KIT 22-027, GK1071, AME STANDARD KIT 22-030, GK1083, AME STANDARD KIT 22-045, GK1094, AME STANDARD KIT 23-015, GK1096, AME STANDARD KIT 23-017, GK1101, AME STANDARD KIT 23-033, GK131, LAP CHOLE PROCEDURE PACK, GK153, TOTAL 5mm SOLUTION KIT 11, GK168, 10mm ACCESS/LIGATION/RETRIEVAL PK, GK258, AME STANDARD KIT 44, GK260, STANDARD SET 360 Z, GK307, CHOLE KIT 1, GK308, CHOLE KIT 15, GK320, CHOLE KIT 24, GK358, CHOLE KIT 22, GK360, CHOLE KIT 18, GK363, CHOLE KIT 31, GK364, CHOLE KIT 30, GK365, CHOLE KIT 28, GK368, CHOLE KIT 33, GK401, TOTAL 5mm SOLUTION KIT 41, GK402, TOTAL 5mm SOLUTION KIT 42, GK736, LAP. CHOLECYST. CLIP, GK738, STANDARD SET 112 F, GK739, STANDARD SET 397 F, GK834, K100796, GK835, KIT AME 55003, GK837, KIT K86656, GK857, KIT CHOLECYSTECTOMIE LOBBES, GK858, KIT KE284, GK861, KIT VESICULE 11MM CHA, GK874, LAP CHOLE KIT Z-THREAD, GK877, LAP CHOL KIT 5, GK878, SSMC LAP, CHOLE, KIT NO.1, GK879, SSMC LAP, CHOLE, KIT NO. 2, GK891, LAP-GALLE-SET, GK895, KIT HERES LAP CHOL 5MM, GK905, GALLKIT TORSBY SJUKHUS, GK920, K57569, GK921, K57526, GK924, K65251, GK962, LAP CHOL BOOM, GK965, URO- VARIKOCELEN+LYMPHEKTOMIESET, GK969, KIT LAP CHOL TOORENVLIET, GK980, KE78892 LAP PROSTATECTOMY 2, GK983, KIT KE 111515, GK987, LAP. CHOLE-SET LKH MURTAL, GK988, LAPCHOLE KIT ERASME VERSION 4, GK992, K8056 - KIT COLE, GK993, K116634, GK998, GALLEKIT VOSS, JK001, OLYMPUS KIT 1 (2XCTF03,1XCA500), JK003, OLYMPUS KIT 3 (2XCFF05, 1XCA500), JK004, OLYMPUS KIT 4 (2XCTR05, 1XCA500), K0880, DR. THAMES-LAP CHOLE, K0924, DR. COMPTON'S LAP CHOLE PACK, K2212, DR. MILLER LAP CHOLE KIT, K2440, LAP CHOLE KIT, K2607, BORLAND GASTRIC SLEEVE, K2640, LAP CHOLE KIT, K2656, SOUTH SUNFLOWER LAP CHOLE KIT, K2703, DR. AZAR LAP CHOLE PACK, K2705, DRS.GIROD & INGRAM LAP CHOLE PACK, K2797, LAP CHOLE PROCEDURAL PACK 1, K2903, LAP CHOLE KIT, K2922, KIT CLIP APPLIER, K2924, CLIP KIT A, K2925, CLIP KIT F, K2926, CLIP KIT F, K2927, CLIP KIT B, K2928, LAP CHOLE KIT, K2929, LAP CHOLE KIT, K2933, AM MENAT KIT # 0001, K2934, AM MENAT KIT # 0002
- Z-2158-2020 — Epix latis GRASPER, 5 mm x 35 cm, REF C4130, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110147
- Z-2159-2020 — Epix latis GRASPER, 5mm x 45 cm, REF: C4140, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110154
- Z-2161-2020 — Clip Applier Kit, REF: K2887, UDI: (01)30607915139132(17)220822(30)1(10)
- Z-2160-2020 — DR. THAMES - LAP CHOLE, REF: K0880, UDI: (01)30607915139620
- Z-2035-2020 — STEALTH SPRING CLIP 6mm latis (1/4 Force). REF/UDI::A1602/(01)00607915110574 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery.
- Z-2034-2020 — STEALTH SPRING CLIP 6mm latis (1/2 Force). REF/UDI::A1601/(01)00607915110567 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery.
- Z-2036-2020 — STEALTH SPRING CLIP 6mm latis (3/4 Force). REF/UDI::A1603/(01)00607915110581 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Applied Medical Resources Corp.
- K252740 — Voyant® Open Fusion Device (EB240/Open Fusion)
- K252442 — Kii Structural Balloon Access System
- K243152 — GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device
- K201212 — Voyant Open Fusion Device
- K200598 — Voyant Maryland Fusion Device
- K193292 — Voyant 5mm Fusion Device, Voyant Maryland Fusion Device
- K191294 — Transvaginal Access Platform
- K182653 — Voyant Maryland Fusion Device
- K182244 — Voyant Electrosurgical Generator
- K182024 — Dissecting Balloon System
- K171701 — GelPOINT Path Transanal Access Platform
- K132300 — EPIX ELECTROSURGICAL PROBE SPATULA TIP, EPIX ELECTROSURGICAL PROBE L-HOOK TIP, EPIX ELECTROSURGICAL PROBE J-HOOK TIP, RE
- K133393 — GELPOINT PATH TRANSANAL ACCESS PLATFORM
- K113268 — ALEXIS O WOUND PROTECTOR/RETRACTOR
- K110792 — GELPOINT PATH
- K103282 — LAPAROSCOPIC DISSECTOR
- K100120 — ALEXIS ORTHOPAEDIC WOUND RETRACTOR
- K093296 — ALEXIS LAPAROSCOPIC SYSTEM
- K090275 — GELPORT SINGLE INCISION ACCESS SYSTEM
- K083638 — FIXATION TROCARS
- K072674 — KII TROCAR SYSTEM
- K063658 — INTRAVASCULAR INTRODUCER SYSTEM
- K062169 — APPLIED LAPAROSCOPIC DISPOSABLE MONOPOLAR SCISSORS
- K060629 — GELPORT BLUNT TIP TROCAR SYSTEM
- K060673 — PEDIATRIC URETERAL STENT
- K060534 — INTUITIVE SURGICAL SEAL
- K060096 — MODULAR TROCAR SYSTEM
- K060051 — SPECIMEN RETRIEVAL SYSTEM
- K040760 — MODIFICATION TO URETERAL STENT
- K041506 — INTRAVASCULAR ACCESS INTRODUCER SHEATH
- K041795 — MODIFICATION TO OPTICAL SEPARATOR SYSTEM
- K041711 — ALEXIS WOUND RETRACTOR, MODELS C8312, C8301, C8302, C8303, C8304
- K040295 — APPLIED LAPAROSCOPIC MONOPOLAR SCISSORS
- K033024 — MODIFICATION TO SUTURE CLINCH
- K031889 — ALEXIS WOUND RETRACTOR
- K030642 — DEFLECTING URETERAL ACCESS SHEATH
- K020577 — APPLIED URETERAL CATHETER
- K020435 — WOUND PROTECTOR/RETRACTOR
- K014047 — APPLIED GELPORT LAPAROSCOPIC HAND ACCESS DEVICE
- K012884 — DILATING TIP OBTURATOR
- K012968 — APPLIED ACCESS SEAL
- K010006 — DRAINAGE CATHETER OR FOLEY CATHETER
- K011264 — MESH URETERAL STENT
- K003871 — LAPAROSCOPIC HAND PORT
- K011236 — MODIFICATION TO IMPLANTABLE CLIP
Data sourced from openFDA. This site is unofficial and independent of the FDA.