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

Orchard Park, NY, US

CURBELL MEDICAL PRODUCTS, INC. appears in FDA device records in Orchard Park, NY. 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

FDA records under these names

1 name

FDA records resolved to Curbell Medical Products, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Curbell Medical, Inc.enforcement report, recall

510(k) clearance history

FDA records hold 1 510(k) clearance for Curbell Medical Products, Inc. in 2018.

Clearances by year, as a table
510(k) clearance decisions for Curbell Medical Products, Inc., by decision year
YearClearances
20181
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K182220Curbell branded Patient Monitoring CablesDSASubstantially Equivalent

Registered establishments

FDA registered establishments for Curbell Medical Products, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
13203603000210521CURBELL MEDICAL PRODUCTS, INC.20 Centre Dr, ORCHARD PARK, NY 14127 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-2554-2014CURBELL MEDICAL CareSense Wireless Advanced LCD Bed and Chair Monitor, MODEL # CSM-BC400; --- COMMON/USUAL NAME: Bed Patient Monitor; CLASSIFICATION NAME: Bed Patient Monitor --- Monitor is connected to a sensor pad that monitors the patient if they attempt to arise from a bed, chair, floor mat, or toilet seat. The monitor will sound an alarm.The firm became aware of a potential problem that was initiated by a customer complaint. After consultation with the manufacturer, it was discovered that a resistor was incorrectly placed within the circuit board on the monitor. This change to the resistor was a planned change to address a product improvement (improve battery drain). However, this modification rendered the monitor's alarm via the nurse call communication port to not function.Class IITerminated

Verification record

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