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Medagent Inc

Portsmouth, NH, US

MEDAGENT, INC. appears in FDA device records in Portsmouth, NH. FDA records list one 510(k) clearance, 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
1
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 1 510(k) clearance for Medagent Inc in 2015.

Clearances by year, as a table
510(k) clearance decisions for Medagent Inc, by decision year
YearClearances
20151
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K143662Bissinger Monopolar Forceps and CablesGEISubstantially Equivalent

Registered establishments

FDA registered establishments for Medagent Inc, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30072194013007219401MEDAGENT, INC.264 Lafayette Road, Suite 7, Portsmouth, NH 03801 US2026No device listings on this registration

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-1184-2024Rebstock Holding rod for fixation -For holding and fixation of flexible Leyla Arms and spatula Art. No. 06-06-285 and 06-06-285MOD. surgical instrument.Holding arm could move (twist) uncontrollably in the front area. This could lead to a serious deterioration of patient's safety if the movement is transferred to the spatula, which is attached to the holding arm.Class IIOpen, Classified

Verification record

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What MDM checks, and what it does not

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