Panels › Obstetrics/Gynecology › Product code HGM · Class 2
System, Monitoring, Perinatal
Regulation 884.2740
2510(k)s in 12 months (215 all time)
5recalls in 12 months (28 all time)
22recalls that name a 510(k)
Top companies in HGM
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 25, 2009 | K091251 | CERNER FETALINK (VERSION 1.0) Cerner Corp. | HGM |
| Jul 15, 2009 | K090285 | SONICAID FM820 AND FM830 ENCORE Huntleigh Healthcare , Ltd., GB | HGM |
| Feb 13, 2009 | K090269 | AIRSTRIP OB Airstrip Technologies, LP | HGM |
| Jan 23, 2009 | K090061 | AIRSTRIP OB Airstrip Technologies, LP | HGM |
| Nov 26, 2008 | K082602 | FETAL & MATERNAL MONITOR, MODEL F6, F9 Edan Instruments, Inc. | HGM |
| Nov 7, 2008 | K082369 | CADENCE, CADENCE DUAL, CADENCE II FETAL MONITOR Edan Instruments, Inc. | HGM |
| May 28, 2008 | K081203 | OB TRACEVUE OBSTETRICAL INFORMATION MANAGEMENT SYSTEM WITH RELEASE F.00 Philips Medizin Systeme Boeblingen GmbH, DE | HGM |
| Apr 9, 2008 | K080226 | NAVICARE -WATCHCHILD OBSTETRICAL DATA MANAGEMENT SYSTEM (NAVICARE -WATCHCHILD), MODEL P2912 Hill-Rom Manufacturing, Inc. | HGM |
| Dec 28, 2007 | K073221 | CADENCE II Edan Instruments, Inc. | HGM |
| Dec 20, 2007 | K072976 | MODEL 250CX SERIES MATERNAL/FETAL MONITOR GE Healthcare | HGM |
| Sep 27, 2007 | K071800 | PHILIPS AVALON FETAL MONITORS FM20 AND FM30 Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, DE | HGM |
| Aug 24, 2006 | K062137 | MODIFICATION TO PHILIPS AVALON FETAL MONITORS FM20 AND FM30 Philips Medizin Systeme Boeblingen GmbH, DE | HGM |
| Apr 10, 2006 | K050826 | FETAL ULTRASOUND AND TOCODYNAMOMETER TRANSDUCERS Cetro America | HGM |
| Mar 23, 2006 | K060230 | DOPPLEX CENTRALE Huntleigh Healthcare , Ltd., GB | HGM |
| Feb 17, 2006 | K051175 | CIV-OB OBSTRICAL MONITORING SOFTWARE APPLICATION Civent Communications, Ltd., IL | HGM |
| Dec 30, 2005 | K052795 | PHILIPS AVALON FETAL MONITOR, MODELS FM20 AND FM30 Philips Medizin Systeme Boeblingen GmbH, DE | HGM |
| Dec 22, 2005 | K052715 | CALM CURVE, VERSION 01.00 Lms Medical Systems (Canada), Ltd., CA | HGM |
| Dec 16, 2005 | K043598 | FC 1400 FETAL MONITOR Bionet Co., Ltd., KR | HGM |
| Dec 16, 2005 | K043597 | FC 700 FETAL MONITOR Bionet Co., Ltd., KR | HGM |
| Oct 4, 2005 | K052190 | FETAL MONITOR, MODELS BT-300 AND BT-200 Bistos Co., Ltd. | HGM |
| Aug 25, 2005 | K050234 | REMOTE CARE E.Care Solutions, Inc. | HGM |
| Aug 18, 2005 | K043075 | TENACORE TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING Tenacore Holdings, Inc. | HGM |
| Jun 21, 2005 | K050583 | MODEL 250 SERIES MATERNAL/FETAL MONITOR Ge Medical Systems Information Technologies | HGM |
| Feb 8, 2005 | K040788 | CALM PATTERNS, VERSION 01.00.00 Lms Medical Systems , Ltd., CA | HGM |
| Jan 21, 2005 | K042082 | AIRSTRIP OB Mp4 Solutions, LP | HGM |
| Sep 2, 2004 | K040903 | CADENCE, MODELS 2001 AND 2002 Edan Instruments, Inc. | HGM |
| Aug 16, 2004 | K040819 | TRANSDUCER FOR ULTRASOUND FETAL MONITORING, MODELS FM10833 AND FM10834 American I.V. Products, Inc. | HGM |
| Oct 8, 2003 | K032772 | MODIFICATION TO WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM (ALSO REFERRED TO AS) THE WATCHCHILD SYSTEM Hill-Rom Manufacturing, Inc. | HGM |
| Aug 21, 2003 | K032252 | MODEL 120 SERIES MATERNAL/FETAL MONITOR Ge Medical Systems Information Technologies | HGM |
| Apr 24, 2003 | K030261 | BATTERY, RECHARGEABLE Access Battery, Inc. | HGM |
| Feb 24, 2003 | K023931 | PHILIPS AVALON CTS CORDLESS FETAL TRANSDUCER SYSTEM, MODELS M2720A, M2725A, M2726A, M2727A Philips Medical Systems, Inc., NL | HGM |
| Jan 22, 2003 | K023618 | SONICAID ONE Oxford Instruments Medical , Ltd., GB | HGM |
| Aug 12, 2002 | K021574 | TM2000 FETALTRACE TRANSTELEPHONIC RECEIVING CENTER Card Guard Scientific Survival , Ltd., IL | HGM |
| May 9, 2002 | K021135 | MODEL 2120IS SERIES MATERNAL/FETAL MONITOR Ge Medical Systems Information Technologies | HGM |
| Apr 18, 2002 | K013281 | VERSALAB APM Nicolet Biomedical | HGM |
| Jan 11, 2002 | K014094 | MODIFICATION TO THE WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM Hill-Rom Manufacturing, Inc. | HGM |
| Nov 13, 2001 | K012718 | MODIFICATION TO COROMETRICS MODEL 120IS MATERNAL/FETAL MONITORING SYSTEM. Ge Medical Systems Information Technologies | HGM |
| May 29, 2001 | K011304 | OB-1 FETAL MONITOR Analogic Corp. | HGM |
| May 11, 2001 | K010552 | CG-900P FETAL/MATERNAL MONITOR Card Guard Scientific Survival , Ltd., IL | HGM |
| Apr 27, 2001 | K992607 | SONICAID SYSTEM 8002 Oxford Instruments Medical Systems | HGM |
| Apr 25, 2001 | K010894 | BABY DOPPLEX 3002 (BD3002) Huntleigh Healthcare, Inc., GB | HGM |
| Apr 25, 2001 | K010889 | BABY DOPPLEX 3000 MK 2 (BD3000) Huntleigh Healthcare, Inc., GB | HGM |
| Mar 9, 2001 | K002150 | SONICAID FM820, SONICAID FM830 Oxford Instruments, GB | HGM |
| Mar 6, 2001 | K002548 | FETAL ASSIST Huntleigh Diagnostics , Ltd., GB | HGM |
| Nov 9, 2000 | K002503 | FETALGARD LITE Analogic Corp. | HGM |
| Sep 29, 2000 | K994008 | BIOSYS FETAL MONITOR, MODEL IFM-500 Biosys Co. , Ltd. | HGM |
| Sep 19, 2000 | K001882 | BABY DOPPLEX 4002-TWINS, MODEL BD4002 Huntleigh Healthcare, Inc. | HGM |
| Aug 14, 2000 | K001677 | BABY DOPPLEX 4000 (BD4000) Huntleigh Diagnostics , Ltd., GB | HGM |
| Feb 2, 2000 | K993751 | COROMETRICS MODEL 173 FETAL MONITOR Ge Medical Systems Information Technologies | HGM |
| Jan 24, 2000 | K990569 | BABY DOPPLEX 4000, MODEL BD 4000 Huntleigh Healthcare, Inc. | HGM |
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