Deknatel, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
37
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K963850PLEUR-EVAC SAHARA PLUS MODEL S-1150 CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEMApril 22, 1997
K962683SNOWDEN-PENCER COMPUTERIZED HIGH FLOW INSUFFLATORJanuary 10, 1997
K964070DEKNATEL DSP PLEUR-EVAC AUTOTRANSFUSION BLOOD RECOVERY BAGDecember 31, 1996
K963098PLEUR-EVAC SHARA PLUS MODEL S-2150/CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM(S-100)November 8, 1996
K962856PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITAugust 28, 1996
K925243DEKNATEL(TM) PLEUR-EVAC(R) THORACIC CATHETERJuly 27, 1994
K930740SURGICAL SUTURE, NONABSORABLE STAINLESS STEELJuly 26, 1994
K930738SURGICAL SUTURES, PGL, GUT, DEKLENE, OPTHAMEND ETCJuly 26, 1994
K930739SUTURES POLYPROP., POLYETHELINE, NYLON & SILKJuly 26, 1994
K926338PLEUR-EVAC CARDIOTOMY RESERVOIR # CR-9400 & 9400FJuly 26, 1994
K931106BIOSURGE(TM) SYNCHRONOUS AUTOTRANS PROCEDURE KITOctober 6, 1993
K924337PLEUR-EVAC(R) ADULT/PEDI DUAL COLL CHEST DRAIN SYSJuly 28, 1993
K925046PLEUR-EVAC CARDIOTOMY RESERVOIRApril 20, 1993
K911905DEKNATEL(R) MICROFLEX OPHTHAL POLY SUTURE,MODIFIEDJuly 2, 1991
K910211ORTH-EVAC(TM) SUCTION HAND BULB MODEL NO. 01-150April 3, 1991
K905768PLEUR-EVAC CHEST DRAINAGE SYSTEMSFebruary 11, 1991
K903643DEKNATEL MICROFLEX OPHTHALMIC POLYPROPYLENE SUTUREDecember 24, 1990
K900325ORTH-EVAC TMJuly 3, 1990
K896697PLEUR-EVAC(R) A-6020--INFANT SINGLE USE CHEST DRAIFebruary 8, 1990
K892915PLEUR-EVAC A-8002--ADULT/PEDIATRIC DUAL COLLECTIONJune 21, 1989