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

North Miami Beach, FL, US

STAT MEDICAL DEVICES, INC. appears in FDA device records in North Miami Beach, FL. FDA records list 4 510(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
4
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 4 510(k) clearances for Stat Medical Devices, Inc. between 2009 and 2023. The busiest year on record is 2023, with 3. The most recent is 2023, with 3.

Clearances by year, as a table
510(k) clearance decisions for Stat Medical Devices, Inc., by decision year
YearClearances
20091
20233
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K230310STAT Medical Device Lancing SystemQRKSubstantially Equivalent
K222617EasyTouch Lancing DeviceQRKSubstantially Equivalent
K223815ONE DROP Lancing DeviceQRKSubstantially Equivalent
K092016SUPER-FINE PEN NEEDLEFMISubstantially Equivalent

Registered establishments

FDA registered establishments for Stat Medical Devices, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
10589551000525253STAT MEDICAL DEVICES, INC.2056 NE 153rd St, North Miami Beach, FL 33162 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-1596-2009Stat (TM) Super-Fine (TM) Pen Needles and Allison Medical, Inc. Sure Comfort Pen Needles with Silicone Tip, for human use with insulin pen injector device to administer insulin subcutaneously.Stat Pen Needles with silicone coating have not been cleared by FDA for use with silicone coating which could significantly affect the safety and effectiveness of the device.Terminated

Verification record

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