Atlas FDA

DPS

576 FDA 510(k) clearances · Product code

Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
GALIX ECG PROFESSIONAL STATION (K051163)Galix Biomedical Instrumentation, Inc.2006-01-31
CARDIOSOFT PC ECG, USB VERSION (K052295)Cardiosoft, L.P.2006-01-13
READMYHEART, MODEL RMH2.0 (K052303)Dailycare Biomedical, Inc.2005-12-16
DATRIX CARDIO WIFI ELECTROCARDIOGRAPH (K053083)Datrix2005-11-30
CARDIOLINE AR 600, AR 1200, AR 2100 (K051534)Et Medical Devices Spa2005-10-05
PHILIPS 12-LEAD ALGORITHM (K052049)Philips Medical Systems2005-08-26
READMYHEART, MODEL RMH3.0 (K050620)Dailycare Biomedical, Inc.2005-07-14
ASCENTIA HEARTSTATION ECG MANAGEMENT SYSTEM (K050858)Heartlab, Inc.2005-06-29
CARDIOSCOPE SONOPLUS 3000 (K051126)Pulsonic Ag, Medical Technology2005-05-19
CARDIOVIT AT-10PLUS (K050686)Schiller AG2005-05-04
MONEBO AUTOMATIC ARRHYTHMIA DETECTION SOFTWARE LIBRARY, VERSION 1 (K043380)Monebo Technologies, Inc.2005-04-26
12-LEAD RESTING ELECTROCARDIOGRAPH, MODELS CP100 & CP200 (K050074)Welch Allyn, Inc.2005-03-22
LIBERTY SYSTEM (K043074)Inovise Medical, Inc.2005-02-22
CARDIOFAX CE, MODEL PEA-1110K (K042827)Nihon Kohden America, Inc.2005-01-06
READMYHEART (K042814)Dailycare Biomedical, Inc.2005-01-06
MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM (K042177)Ge Medical Systems Information Technologies2004-08-27
CMI MAGNETOCARDIOGRAPH (K033488)Cmi Cardiomag Imaging, Inc.2004-07-07
CARDIOVIT AT-102 (K031557)Schiller AG2004-04-14
HRV TOOLS (K040313)Del Mar Reynolds Medical, Ltd.2004-04-06
AUDICOR UPGRADE SYSTEM (K032145)Inovise Medical, Inc.2003-10-31
ELAN DIGITAL 12 CHANNEL ELECTROCARDIOGRAPH (K032200)Remco Italia S.P.A.2003-10-03
CARDIODIRECT, MODELS 12M, 12I, 12S (K024283)Reynolds Medical , Ltd.2003-08-01
ELI 200+ AUDICOR (K031182)Mortara Instrument, Inc.2003-07-25
PHILIPS PAGE WRITER TRIM SERIES CARDIOGRAPH INCLUDING I, II, III, MODELS 860286, 860287, 860288, 860289, 860290, 860291 (K031422)Philips Medical Systems2003-07-03
EKGCARD SYSTEM (K030535)Qrs Diagnostic, LLC2003-06-11
PRIME ECG SYSTEM (K030104)Meridian Medical Technologies, Inc.2003-06-11
PACEART SYSTEM (K024278)Medtronic Vascular2003-05-29
HERO (K021230)Medical Decision Networks2003-05-09
X-SCRIBE II (K022618)Mortara Instrument, Inc.2002-09-06
HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS (K022152)Cambridge Heart, Inc.2002-07-16
CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000 (K022149)Cambridge Heart, Inc.2002-07-16
MICRO-INDUCTION 1000 SYSTEM (K013615)Harbinger Medical, Inc.2002-05-29
Q-STRESS ECHO BED (K021171)Medical Positioning, Inc.2002-05-08
GLOBAL ECG MANAGEMENT SYSTEM (GEMS) (K020366)Cardiocomm Solutions, Inc.2002-04-30
PHILIPS PAGEWRITER TOUCH CARDIOGRAPH, MODEL M5000A SERIES (K020708)Philips Medical Systems, Inc.2002-04-25
COSMED QUARK C12/QUARK T12 (K014262)Cosmed Srl2002-03-26
PRIME ECG SYSTEM (K012414)Meridian Medical Technologies, Inc.2002-03-06
BRENTWOOD REAL TIME ST AND ARRHYTHMIA ANALYSIS SOFTWARE LIBRARY (K013717)Brentwood Medical Technology Corp.2002-02-06
CARDIOCOLLECT PORTABLE ELECTROCARDIOGRAPH (K013367)Reynolds Medical , Ltd.2001-12-13
CAIRD TECHNOLOGY HOLTER 2000 (K012686)Caird Technology2001-12-13
MODIFICATION TO HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS (K013564)Cambridge Heart, Inc.2001-11-21
CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000 (K013565)Cambridge Heart, Inc.2001-11-21
MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWC (K012264)National Custom Ent., Inc.2001-10-10
MARQUETTE EAGLE MONITOR MODEL 4000, MODEL N3024 (K012263)National Custom Ent., Inc.2001-10-10
BLY-501 ADAPTOR (K012540)Micromedical Industries, Ltd.2001-09-26
MOBILE-PATIENT VIEWER (K011436)Data Critical Corporation2001-07-05
BCI ADVISOR VITAL SIGNS MONITOR (9200) (K011177)Bci, Inc.2001-05-23
BMT ANSCORE HEALTH MANAGEMENT SYSTEM (K010955)Boston Medical Technologies, Inc.2001-04-26
AB CARDIETTE START 200 HV (K010822)H&C Medical Devices Spa2001-04-18
HEARTWAVE ALTERNANS PROCESSING SYSTEM, APS (K010758)Cambridge Heart, Inc.2001-04-12
TELEMED 12 LEAD RESTING ECG ANALYSIS LIBRARY (K010505)Brentwood Medical Technology Corp.2001-03-09
VERTEX SYSTEM (K002822)Medical Positioning, Inc.2001-01-31
CARDIO MONITOR CENTER VISION; MODEL S-CV7-00 (K003392)Shl Telemedicine International , Ltd.2001-01-25
KENZ ECG 108 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS; KENZ ECG 110 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS WITH EC (K001896)Suzuken Co., Ltd.2001-01-08
CARTOUCH (K002197)Cardionics, Inc.2000-12-27
WEC-7101A POCKET SIZE ECG MONITOR AND ACCESSORIES (K002473)Nihon Kohden America, Inc.2000-11-08
PAGEWRITER 10/10I, MODEL M2662A HANDHELD ELECTROCARDIOGRAPH (K002459)Agilent Technologies, Inc.2000-11-08
AB CARDIETTE DAEDALUS VIEW BASE AND AB CARDIETTTE DAEDALUS VIEW HES (K002074)H&C Medical Devices Spa2000-10-04
BMT ANSCORE HEALTH MANAGEMENT SYSTEM (K993875)Boston Medical Technologies, Inc.2000-08-11
QUINTON Q-STRESS, MODEL 000483 (K001492)Quinton, Inc.2000-08-09
MODEL APS ALTERNANS PROCESSING SYSTEM (K001034)Cambridge Heart, Inc.2000-06-09
GE MARQUETTE MEDICAL SYSTEMS PRUCKA CARDIOLAB CATH SYSTEM, VERSION 1.11 (K000645)General Electric Medical Systems Information Techn2000-05-24
PRUCKA ENGINEERING INC. CARDIOLAB EP SYSTEM,VERSION 4.2 (K993414)Prucka Engineering, Inc.2000-04-07
MARS UNITY WORKSTATION WITH HEART RATE VARIABILITY (HRV) OPTION (K991786)General Electric Medical Systems Information Techn1999-11-18
BMT ANSCORE HEALTH MANAGEMENT SYSTEM, MODEL 1.1 (K991831)Boston Medical Technologies, Inc.1999-06-11
MONITOR ONE NDX (K972991)Qmed, Inc.1998-12-03
CAMBRIDGE HEART CH 2000 CARDIAC DIAGNOSTIC SYSTEM (K981697)Cambridge Heart, Inc.1998-10-14
MICROMEDICAL 12 LEAD SIMULTANEOUS CABLE (K974220)Micromedical, Inc.1998-08-25
CARDIOVISION SOFTWARE, MODEL S-CV5-96 (K981807)Shl Telemedicine International , Ltd.1998-08-19
ANS 2000 ECG MONITOR AND RESPIRATION PACER (K973426)D. E. Hokanson, Inc.1998-08-12
CT 200 ELECTROCARDIOGRAPH (K961798)Macquarie Medical Systems1998-08-05
CT 100 ELECTROCARDIOGRAPH (K981951)Macquarie Medical Systems1998-07-28
MRI COMPATIBLE MONITOR AND ACCESSORIES (K980362)Datex-Engstrom, Inc.1998-06-30
EASY ECG PC BASED ELECTROCARDIOGRAPH (K972996)Ates Medical S.R.L.1998-04-28
BIOLOG 3000 ELECTROCARDIOGRAPH (K974351)Micromedical, Inc.1998-04-01
M1765A ECG MANAGER (K974746)Hewlett-Packard Co.1998-03-18
ELECTROCARDIOGRAPHS MODELS 110B, 120B AND 310B (K972603)Dr. Lee Co., Ltd.1998-03-11
FORMULA FOR ARCHIMED (K974079)Biosound Esaote, Inc.1998-01-22
HEWLETT-PACKARD MODELS M1001B ECG M1002B ECG/RESPIRATION PLUG-IN MODULES (K973437)Hewlett-Packard GmbH1997-12-03
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP6/100 (K972746)Alexander Mfg. Co.1997-10-21
SIGNAL-AVERAGED HIGH RESOLUTION P WAVE ANALYSIS (K972199)Marquette Electronics, Inc.1997-09-25
KONTRON KOLORMON PLUS ECG WITH RESPIRATION MODULE (K971038)Kontron Instruments , Ltd.1997-09-24
NIHON KOHDEN QP-932E ECG EXERCISE TEST OPTION FOR THE NIHON KOHDEN ECG-9320/A CARDIOFAX ELECTROCARDIOGRAPH (K972310)Nihon Kohden America, Inc.1997-08-20
SYNERGY CARDIOLOGY INFORMATION SYSTEM (00431) (K964784)Quinton, Inc.1997-08-13
POSEIDON CARDIAC MONITORING SYSTEM (PCMS) (K964408)Instromedix, Inc.1997-07-23
PC BASED ELECTROCARDIOGRAPH SYSTEM (PC-ECG) (K963578)Intl. Products, Inc.1997-06-30
ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M3) (K970787)Alexander Mfg. Co.1997-05-14
PS-41 6M PATIENT SIMULATOR (K963198)Metron U.S., Inc.1997-03-05
NELLCOR SYMPHONY N-3000 PATIENT MONITOR WITH SPO2 AND ECG AND N-3200 DISPLAY/PRINTER (K963400)Nellcor Puritan Bennett, Inc.1996-11-26
AS/3 LIGHT MONITOR (K961247)Datex Division Instrumentarium Corp.1996-10-23
HP CATHSTATION - MODEL M1264B (K961401)Hewlett-Packard Co.1996-10-08
CARDIOVIEW TRANSTELEPHONIC SOFTWARE (K955891)Micromedical, Inc.1996-10-08
MEDILOG STRESSLINK (K951128)Oxford Medical, Inc.1996-08-28
CARDIOCATH CATHETERIZATION LAB SYSTEM (K960321)Prucka Engineering, Inc.1996-08-21
PATIENT MONITOR MODEL 405P (K955546)Ivy Biomedical Systems, Inc.1996-08-16
DINAMAP SELECT MULTI-PARAMETER SYSTEM (K955113)Johnson & Johnson Medical, Inc.1996-08-15
CARDIMAX MODEL FX-2111 (K955416)Fukuda Denshi USA, Inc.1996-07-15
OMNI-TRAK PATIENT MONITORING SYSTEM (K955045)Invivo Research, Inc.1996-07-11
NELLCOR SYMPHONY N-3000 PATIENT MONITOR W/SP02 & ECG/N-3200 DISPLAY/PRINTER (K955642)Nellcor Puritan Bennett, Inc.1996-07-02
PC ECG 1200 ECG AND STRESS ELECTROCARDIOGRAPHY TESTING SYSTEM(VERSION 2.90) (K960449)Biosensor Corp.1996-05-30
← Previous Next →

Track DPS automatically

Every clearance here is in the API, with alerts when new ones post.