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

Ontario, CA

Carroll Healthcare, Inc. appears in FDA device records in Ontario, CA. FDA records list one 510(k) clearance, no PMA records and no registered establishments. As of , FDA records show 2 recalls for this company.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
2
Registered establishments
0

510(k) clearance history

FDA records hold 1 510(k) clearance for Carroll Healthcare, Inc. in 1996.

Clearances by year, as a table
510(k) clearance decisions for Carroll Healthcare, Inc., by decision year
YearClearances
19961
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K962250CARROLL HEALTHCARE DLX 2300-111 ELECTRIC BEDFNLSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0920-05Carroll Healthcare brand Spirit bed; models BH2180-111AE, BH2180-111PE and BH2180-111FE.The diodes in the control panel may fail, which could result in the thermal breakdown of the circuit board inside of the control box, and cause the bed to cease functioning.Terminated
Z-0919-05Carroll Healthcare brand Arro bed models BA3180-151 AE, BA3180-151 PE, BA3180-151 FE, BA3180-171 AE, BA3180-171 FE and BA3180-171 FE.The diodes in the control panel may fail, which could result in the thermal breakdown of the circuit board inside of the control box, and cause the bed to cease functioning.Terminated

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