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Medical device manufacturer

Conmedcorp

Conmedcorp holds 92 FDA 510(k) clearances across 23 product codes. Median elapsed review time is 82 days. openFDA lists no recall records naming the company.

Updated · ingest status · JSON

510(k) clearances
92
Product codes
23
Median review
82 days
Recall records
0

How does FDA spell Conmedcorp?

FDA publishes this company under a single spelling, so nothing needed merging here. Many manufacturers are not so tidy.

Which product codes does Conmedcorp file in?

23 product codes, ranked by how much they file in each.

Product codes this company holds clearances in, with their median elapsed review time in each.
CodeDeviceClearancesMedian reviewLatest
GEIElectrosurgical, Cutting & Coagulation & Accessories4358 days
GCJLaparoscope, General & Plastic Surgery1061 days
DRXElectrode, Electrocardiograph6140 days
GXYElectrode, Cutaneous687 days
CACApparatus, Autotransfusion361 days
HETLaparoscope, Gynecologic (And Accessories)3262 days
DROPacemaker, Cardiac, External Transcutaneous (Non-Invasive)292 days
DSACable, Transducer And Electrode, Patient, (Including Connector)214 days
GCILaryngoscope, Endoscope247 days
LKFCannula, Manipulator/Injector, Uterine2202 days
DRSTransducer, Blood-Pressure, Extravascular142 days
DWGElectrosurgical Device1333 days
FGEStents, Drains And Dilators For The Biliary Ducts125 days
FPASet, Administration, Intravascular1111 days
GEACannula, Surgical, General & Plastic Surgery155 days
HIFInsufflator, Laparoscopic192 days
KGXTape And Bandage, Adhesive182 days
KMKDevice, Intravascular Catheter Securement1119 days
KNTTubes, Gastrointestinal (And Accessories)115 days
KPLColonic Irrigation System186 days
LDDDc-Defibrillator, Low-Energy, (Including Paddles)1102 days
MGPDressing, Wound And Burn, Occlusive174 days
OCYEndoscopic Guidewire, Gastroenterology-Urology128 days

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 Conmedcorp had a recall?

openFDA lists no recall records naming this company. That is the absence of a record, not a guarantee — and it counts only recalls FDA has published under a spelling we resolved to this company.

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 Conmedcorp cleared recently?

Most recent 510(k) clearances for this company, newest first.
510(k)DeviceCodeDecisionElapsed days
K101534CONMED ALTRUS THERMAL TISSUE FUSION SYSTEMGEI174
K061021ENTAKE STANDARD AND SAFETY PEG SYSTEMKNT15
K050992CONMED IRRIGATION NOZZLEKPL86
K050777PROFORMA HF 4.5 CANNULA, MODEL 050906, 050907FGE25
K050304FX WIRE ADVANCED MEASUREMENT GUIDEWIREOCY28
K041953VERSASTIM, PERFOAMAX, SURGI-STIM, FASTSTARTGXY20
K021079ABCSNARE ELECTROSURGICAL PROBE FOR FLEXIBLE ENDOSCOPES, MODEL 1336XXGEI89
K021299CONMED HEATWAVE HAND-CONTROLLED ELETRODEGEI63
K020186CONMED SYSTEM 5000 ESUGEI84
K020135CONMED SYSTEM 2000 ELECTROSURGICAL GENERATOR, REF: 60-8002; CONMED ESU CART, REF: 60-6120GEI87

Source: openFDA device/510k · retrieved

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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.