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Ambu, Inc.

FDA 510(k) & PMA Approved Devices — 33 products

Total Devices33
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K051529 AMBU NEUROLINE GROUNDGXY2005-08-04 View
510(k) K042682 AMBU SPUR II. ADULT SINGLE PATIENT RESUSCITATORBTM2004-11-15 View
510(k) K042843 AMBU SPUR II INFANT AND PEDIATRIC SINGLE PATIENT USE RESUSCITATORSBTM2004-11-12 View
510(k) K041734 AMBU DISPOSABLE ECG ELECTRODEDRX2004-09-22 View
510(k) K040991 AMBU DISPOSABLE PRESSURE MANOMETERCAP2004-07-22 View
510(k) K041026 AMBU BLUE SENSOR, MRX, ECG ELECTRODE PRODUCT #:MRX-00-SDRX2004-06-28 View
510(k) K032278 AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODEGXY2004-03-05 View
510(k) K032421 AMBU PEDIATRIC MULTI-FUNCTION DEFIBRILLATION ELECTRODEMKJ2004-02-27 View
510(k) K010583 AMBU GEL, HYDROGEL BURN DRESSINGMGQ2001-05-25 View
510(k) K993278 AMBU NEONATE SILICONE RESUSCITATORBTM2000-05-17 View
510(k) K992902 AMBU HAND POWER SUCTION PUMPBSY1999-10-25 View
510(k) K982722 AMBU MEDIBAG ADULT, AMBU MEDIBAG INFANT/CHILDCAF1999-04-12 View
510(k) K981891 AMBU TUBECHECKBTR1998-07-17 View
510(k) K964584 AMBU SPUR NEONATEBTM1997-05-15 View
510(k) K932031 AMBU PORTABLE SUCTION UNITBTA1995-05-05 View
510(k) K932014 AMBU DISPOSABLE FACE MASKBSJ1993-06-22 View
510(k) K923762 SPUR INFANT/CHILD W/O PRESSURE-LIMITING VALVEBTM1993-02-05 View
510(k) K923976 AMBU SINGLE PATIENT USE PEEP VALVEBYE1993-01-05 View
510(k) K924216 AMBU SILICONE RESUSCITATOR INFAN/CHILD W/OPEN RESOBTM1992-09-16 View
510(k) K924215 AMBU SILICONE RESUSCITATOR, ADULT W/OPEN RESERVOIRBTM1992-09-16 View
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