510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Cardio Medical Products, Inc.

Rockaway, NJ, US

CARDIO MEDICAL PRODUCTS, INC. appears in FDA device records in Rockaway, NJ. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
3
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 3 510(k) clearances for Cardio Medical Products, Inc. in 2011.

Clearances by year, as a table
510(k) clearance decisions for Cardio Medical Products, Inc., by decision year
YearClearances
20113
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K103651CARDIOMEDLDDSubstantially Equivalent
K103334CARDIO MEDLDDSubstantially Equivalent
K103159CARDIO MED MODEL A102, H104, O101, P103, AND Z100LDDSubstantially Equivalent

Registered establishments

FDA registered establishments for Cardio Medical Products, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
22463402246340CARDIO MEDICAL PRODUCTS, INC.385 Franklin Ave Ste L, ROCKAWAY, NJ 07866 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1669-2013Cardio 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 Jersey 07866 www.cardiomedicalproducts.com (800) 227-3633 (973) 586-9624 FAX DefibrillatorCovidien received customer reports of Arcing/Sparking on the defibrillation electrode leadwire which may affect Cardio Medical Products Inc. defibrillator electrodes Model Number O101.Class IITerminated

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Data as of , FDA export datePage updated Source: openFDA, public domain