Medical device manufacturer
Applied Medical Resources Corp
Applied Medical Resources Corp holds 115 FDA 510(k) clearances across 30 product codes. Median elapsed review time is 88 days. openFDA lists 75 recall records naming the company. FDA publishes it under 6 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 115
- Product codes
- 30
- Median review
- 88 days
- Recall records
- 75
How does FDA spell Applied Medical Resources Corp?
FDA publishes this company under 6 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| APPLIED MEDICAL RESOURCES CORP. | device/registrationlisting | normalised |
| Applied Medical Resources | device/510k | normalised |
| Applied Medical Resources Corp | device/enforcement | normalised |
| Applied Medical Resources Corp | device/recall | normalised |
| Applied Medical Resources Corp. | device/510k | normalised |
| Applied Medical Resources Corporation | device/510k | normalised |
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does Applied Medical Resources Corp file in?
30 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 26 | 44 days | |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 21 | 74 days | |
| HET | Laparoscope, Gynecologic (And Accessories) | 7 | 97 days | |
| KGW | Ring (Wound Protector), Drape Retention, Internal | 7 | 77 days | |
| FAD | Stent, Ureteral | 5 | 83 days | |
| DXE | Catheter, Embolectomy | 4 | 95 days | |
| EYB | Catheter, Ureteral, Gastro-Urology | 4 | 46 days | |
| FER | Anoscope And Accessories | 4 | 58 days | |
| FZP | Clip, Implantable | 4 | 28 days | |
| DYB | Introducer, Catheter | 3 | 210 days | |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | 3 | 60 days | |
| GBZ | Catheter, Cholangiography | 3 | 177 days | |
| HEW | Culdoscope (And Accessories) | 3 | 329 days | |
| LYK | Angioscope | 3 | 88 days | |
| DXC | Clamp, Vascular | 2 | 91 days | |
| KKX | Drape, Surgical, Antimicrobial | 2 | 66 days | |
| DSS | Clip, Vascular | 1 | 90 days | |
| DWX | Stripper, Artery, Intraluminal | 1 | 247 days | |
| EZB | Stylet For Catheter, Gastro-Urology | 1 | 10 days | |
| EZL | Catheter, Retention Type, Balloon | 1 | 204 days | |
| FEB | Accessories, Cleaning, For Endoscope | 1 | 239 days | |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 1 | 238 days | |
| GCM | Endoscope, Rigid | 1 | 81 days | |
| GDW | Staple, Implantable | 1 | 281 days | |
| HIF | Insufflator, Laparoscopic | 1 | 565 days |
Showing the 25 they file in most, of 30.
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Applied Medical Resources Corp had a recall?
openFDA lists 75 recall records naming this company across its whole history, of which 1 was opened in the last 12 months and is not yet marked terminated. A recall record covers one firm's corrective action and may span many device lots.
Z-1010-2026Class IIOpen, ClassifiedGCJ
There is the potential for extended length of the blade obturator after assembly into the cannula and seal housing.
Z-1388-2024Class IIOpen, ClassifiedMDM
Their is the potential that Universal Clip applier may not load clip after the trigger is actuated.
Z-1389-2024Class IIOpen, ClassifiedMDM
Their is the potential that Universal Clip applier may not load clip after the trigger is actuated.
Z-2158-2020Class IITerminatedNWV
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 tissue damage.
Z-2159-2020Class IITerminatedNWV
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 tissue damage.
Showing the 5 most recently initiated of 75.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Applied Medical Resources Corp cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| 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 | 30 | |
| K253531 | Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302) | KGW | 102 | |
| K252740 | Voyant® Open Fusion Device (EB240/Open Fusion) | GEI | 68 | |
| K252442 | Kii Structural Balloon Access System | GCJ | 88 | |
| K252412 | Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator) | GEI | 91 | |
| K243152 | GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device | HEW | 367 | |
| K232880 | Inzii Ripstop Redeployable Retrieval System | GCJ | 44 | |
| K222284 | Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214) | GEI | 74 | |
| K220969 | GelPOINT V-Path Vaginal Access System | MOK | 165 | |
| K211043 | Alexis Contained Extraction System | GCJ | 357 |
Source: openFDA device/510k · retrieved
Where is Applied Medical Resources Corp registered?
FDA lists 1 registered establishment for this company in US.
Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.
Watch what Applied Medical Resources Corp files next
Get an email when this company clears a new device, or when anything is recalled in a product code you follow.
Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.