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Medical device manufacturer

Cordis Corporation

Cordis Corporation holds 328 FDA 510(k) clearances across 75 product codes. Median elapsed review time is 68 days. openFDA lists 147 recall records naming the company. FDA publishes it under 4 different spellings, all counted here as one company.

Updated · ingest status · JSON

510(k) clearances
328
Product codes
75
Median review
68 days
Recall records
147

How does FDA spell Cordis Corporation?

FDA publishes this company under 4 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.

Every spelling FDA published for this company, and which dataset each came from.
As FDA published itDatasetMatched by
Cordis Corp.device/510knormalised
Cordis Corporationdevice/enforcementnormalised
Cordis Corporationdevice/recallnormalised
Cordis Corporationdevice/510knormalised

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 Cordis Corporation file in?

75 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
FGEStents, Drains And Dilators For The Biliary Ducts3832 days
LITCatheter, Angioplasty, Peripheral, Transluminal3087 days
DQOCatheter, Intravascular, Diagnostic2971 days
DQXWire, Guide, Catheter2588 days
DQYCatheter, Percutaneous2263 days
DYBIntroducer, Catheter2284 days
DXYImplantable Pacemaker Pulse-Generator2147 days
JXGShunt, Central Nervous System And Components18123 days
DTBPermanent Pacemaker Electrode1355 days
FJIDialyzer, Capillary, Hollow Fiber861 days
DTKFilter, Intravascular, Cardiovascular583 days
DWZDevice, Biopsy, Endomyocardial568 days
LDFElectrode, Pacemaker, Temporary579 days
KOCAccessories, Blood Circuit, Hemodialysis429 days
DTDPacemaker Lead Adaptor319 days
GWMDevice, Monitoring, Intracranial Pressure362 days
GZBStimulator, Spinal-Cord, Implanted (Pain Relief)316 days
KRGProgrammer, Pacemaker318 days
QEZAspiration Thrombectomy Catheter3108 days
DHCSystem, Test, Systemic Lupus Erythematosus214 days
DJCThin Layer Chromatography, Methamphetamine242 days
DTCAnalyzer, Pacemaker Generator Function240 days
DXTInjector And Syringe, Angiographic245 days
DYGCatheter, Flow Directed214 days
GOLAntigen, Ha (Including Ha Control), Rubella272 days

Showing the 25 they file in most, of 75.

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 Cordis Corporation had a recall?

openFDA lists 147 recall records naming this company across its whole history. A recall record covers one firm's corrective action and may span many device lots.

  • Z-0216-2022Class IIOpen, ClassifiedFGE

    There is a potential for distal tip dislodgement or separation.

  • Z-0217-2022Class IIOpen, ClassifiedFGE

    There is a potential for distal tip dislodgement or separation.

  • Z-0218-2022Class IIOpen, ClassifiedFGE

    There is a potential for distal tip dislodgement or separation.

  • Z-0219-2022Class IIOpen, ClassifiedFGE

    There is a potential for distal tip dislodgement or separation.

  • Z-0220-2022Class IIOpen, ClassifiedFGE

    There is a potential for distal tip dislodgement or separation.

Showing the 5 most recently initiated of 147.

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 Cordis Corporation cleared recently?

Most recent 510(k) clearances for this company, newest first.
510(k)DeviceCodeDecisionElapsed days
K220654ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture GuidewireNTE30
K212977SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbandsDQO153
K210626SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation CatheterLIT52
K202167Brite Tip Radianz Guiding SheathDYB207
K201377SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation CatheterLIT136
K201333SABER .035 PTA Dilatation CatheterLIT115
K181592RAIN Sheath TransradialDYB58
K180081RAILWAY Sheathless Access SystemDYB97
K143412ADROIT Guiding CatheterDQY47
K133843SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILATATION CATHETERLIT191

Source: openFDA device/510k · retrieved

Watch what Cordis Corporation files next

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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.