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

Dallas, TX, US

ESTILL MEDICAL TECHNOLOGIES, INC. appears in FDA device records in Dallas, TX. FDA records list 2 510(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
2
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 2 510(k) clearances for Estill Medical Technologies, Inc between 1999 and 2001. The busiest year on record is 1999, with 1. The most recent is 2001, with 1.

Clearances by year, as a table
510(k) clearance decisions for Estill Medical Technologies, Inc, by decision year
YearClearances
19991
20011
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K012031MODIFICATION TO THERMAL ANGELBSBSubstantially Equivalent
K984640THERMAL ANGELBSBSubstantially Equivalent

Registered establishments

FDA registered establishments for Estill Medical Technologies, Inc, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
16507543002587972ESTILL MEDICAL TECHNOLOGIES, INC.5956 Sherry Ln, Dallas, TX 75225 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-0101-2015Ultra Battery 1 Model: TA-UB1 NSN: 6515-01-592-5803 The Ultra Battery 1 (TA-UB1) is a rechargeable power source for the Thermal Angel Blood and IV Fluid Infusion Warmer. The TA-UB1 battery was designed to provide sufficient power for the Thermal Angel to warm and deliver one liter of blood or IV fluid infusion to a trauma patient.Estill has discovered that a fully discharged Ultra Battery 1 (TA-UB1) will reach 96.9% of its capacity during a 60 minute charging period. If you have a fully discharged Ultra Battery 1 (TA-UB1), in order to achieve a 100% of charge capacity you should charge it for a period of 90 minutes. In addition, the charging voltage range of 10-36V specified on the Ultra Battery 1 (TA-UB1) label and in tClass IITerminated

Verification record

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