Data / Medical devices / United States / Cardio Medical Products, Inc.
Cardio Medical Products, Inc.: FDA-registered device maker in Rockaway, NJ, United States, 3 510(k) clearances
Cardio Medical Products, Inc. is registered with the FDA (registration 2246340) in Rockaway, NJ, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated October 4, 2011. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 2246340
- Address
- 385 Franklin Ave Ste L, Rockaway, NJ, United States, 07866
- Owner or operator
- CARDIO MEDICAL PRODUCTS, INC. (2246340)
- Roles
- Specification developer
- First device listed
- April 6, 2012
- Registered through
- 2027
- Brand names listed
- Cardio Clear, ScatPad
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Barrier, Control Panel, X-Ray, Movable | IWX | 1 | Specification developer | accessdata.fda.gov |
| Dc-Defibrillator, Low-Energy, (Including Paddles) | LDD | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 4, 2011 | K103651 | CARDIOMED | LDD | Substantially Equivalent | Cardio Medical Products, Inc. | accessdata.fda.gov |
| January 18, 2011 | K103334 | CARDIO MED | LDD | Substantially Equivalent | Cardio Medical Products, Inc. | accessdata.fda.gov |
| January 11, 2011 | K103159 | CARDIO MED MODEL A102, H104, O101, P103, AND Z100 | LDD | Substantially Equivalent | Cardio Medical Products, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 26, 2013 | 65462 | Class II | Terminated | Cardio Medical Products, Inc. Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrode Rx Only Single Patient Use Only Manufactured for Cardio Medical Products 385 Franklin Avenue, Suite L Rockaway, New J | Covidien received customer reports of Arcing/Sparking on the defibrillation electrode leadwire which may affect Cardio Medical Products Inc. defibrillator electrodes Model Number O101. | accessdata.fda.gov |
Compare with other makers
- All makers of Barrier, Control Panel, X-Ray, Movable
- All makers of Dc-Defibrillator, Low-Energy, (Including Paddles)
Updated July 8, 2013. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.