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

Stafford, TX, US

Life-Tech Intl., Inc. appears in FDA device records in Stafford, TX. FDA records list 68 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
68
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

Showing 50 of 68

FDA records hold 68 510(k) clearances for Life-Tech Intl., Inc. between 1982 and 2000. The busiest year on record is 1982, with 10. The most recent is 2000, with 1.

Clearances by year, as a table
510(k) clearance decisions for Life-Tech Intl., Inc., by decision year
YearClearances
198210
19833
19842
19853
19865
198710
19884
19891
19906
19911
19924
19939
19942
19955
19962
20001
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K001129PROLONG, MODELS PL50, PL100, PL150CAZSubstantially Equivalent
K955031MAXISTIMKOISubstantially Equivalent
K954505EZ STIMKOISubstantially Equivalent
K954315PVC ABDOMINAL/RECTAL PRESSURE CATHETERFENSubstantially Equivalent
K954341URODYNAMICS TUBING AND INFUSION SETSFENSubstantially Equivalent
K953451UROPUMP TUBE & DAMPING CHAMGERFENSubstantially Equivalent
K953353UROVISION JANUSFENSubstantially Equivalent
K946108EAR-A-GATORKHHSubstantially Equivalent
K913601MICROPHOREGJSubstantially Equivalent
K940203TRIPLE LUMEN URODYNAMIC CATHETER WITH RADIOPAQUE MARKERSFENSubstantially Equivalent
K931179UROLAB SPECTRUMFAPSubstantially Equivalent
K931282VOLUME TRANSDUCEREXQSubstantially Equivalent
K923652DULBECCO'S PHOSPHATE BUFFERED SALINEMFDSubstantially Equivalent
K923651DISTILLED WATERMFDSubstantially Equivalent
K923634MODIFIED F-10 CULTURE MEDIUMMFDSubstantially Equivalent
K923612MODIFIED F-10 CULTURE MEDIUM W/O HYPOXANTHINEMFDSubstantially Equivalent
K926349PROBLOC INSULATED NEEDLESGXZSubstantially Equivalent
K923072HANDTYMPETYSubstantially Equivalent
K923073AUTOMATIC TYMPANOMETERETYSubstantially Equivalent
K923071DANPLEX DIAGNOSTIC AUDIOMETER, CLIN. DIAG. AUDIOMTESDSubstantially Equivalent
K923074DANPLEX SCREENING AUDIOMETEREWOSubstantially Equivalent
K904385JANUS ATAC ENG ANALYSIS SYSTEMGWNSubstantially Equivalent
K915484URETHRALPRESSURE PROFILE CATHETERFAPSubstantially Equivalent
K913184MS-III MINISTIMBXNSubstantially Equivalent
K904557MICROFLOEXYSubstantially Equivalent
K904386UROLAB JANUSFAPSubstantially Equivalent
K903494MAINTENACE FLOW - ACCESORY DEVICE FOR CAVROPUMPDXTSubstantially Equivalent
K903495LIQUID DETECTORDXTSubstantially Equivalent
K902120MERCURY RHINOMANOMETERBXQSubstantially Equivalent
K896784DISPOSABLE URODYNAMIC CATHETER SETKODSubstantially Equivalent
K882585CAVROLABIYNSubstantially Equivalent
K882554MEDITRODE KITEGJUnknown
K881842TRACERBXNSubstantially Equivalent
K874307MODEL DMC-75 MINI-CATHETER SETFPASubstantially Equivalent
K873695MODEL 1859 TUMI/PRESSURE MODULEEXYSubstantially Equivalent
K872039MODEL SK-14 STARTER KIT FOR DENTAL IONTOPHORESISEATSubstantially Equivalent
K870662MODEL SKCK STERILE KNOB COVER KITBXMSubstantially Equivalent
K873109MODEL CC-72 CAVERNOSOMETRY/CAVERNOSOGRAPHY SETOJASubstantially Equivalent
K871129CAVROPUMPDXTSubstantially Equivalent
K872077MODEL 1858 CAVRO/PRESSURE MODULEEXYSubstantially Equivalent
K871869MODIFIED USE FOR MODEL 6110A IONTOPHORETIC APPLI.EGJUnknown
K870272MODEL 6110C OTOPHORETNSubstantially Equivalent
K870118MODEL 6110B DENTAPHOREATSubstantially Equivalent
K870338MODEL MS-II MINISTIMBXNSubstantially Equivalent
K863166MODEL 6110 IONTOPHORETIC APPLICATOREGJSubstantially Equivalent
K863165MODEL 4-SC FOUR WAY STOPCOCKFAPSubstantially Equivalent
K863168MODEL 1101M & 1151M UROLAB MICRO URODYNAMIC RECORDFAPSubstantially Equivalent
K863167MODEL 1350 URODYNAMIC WAVEFORM PROCESSORFAPSubstantially Equivalent
K863169MODEL AS-72 ADMINISTRATION SETFAPSubstantially Equivalent
K862327MODEL RCV REFLUX CHECK VALVEFAPSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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