Atlas FDA

LOS

83 FDA 510(k) clearances · Product code

189 daysmedian time to decision
421 days90th percentile
83clearances measured

FDA profile

Adverse events (MAUDE)
2003: 6 · 2006: 3 · 2008: 3 · 2010: 4 · 2011: 7 · 2012: 6
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
EKG-PLUS II SOFTWARE (K090895)Bionet Co., Ltd.2009-08-26
CARDIOVIEW32 REVIEW MODULE (K083749)Qrs Diagnostic, LLC2009-03-10
PHILIPS ECG ALGORITHM (K073376)Philips Medical Systems2008-04-11
CARDIOTOUCH-3000 (K023034)Bionet Company, Ltd.2002-11-14
CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH (K011328)Bionet Company, Ltd.2001-11-21
CARDIO-CARD INTERPRETATION SYSTEM I (K993616)Nasiff Assoc., Inc.2000-04-10
OXYCONALPHA WITH OPTION ECG (K984465)Erich Jaeger B.V.1999-10-27
CASE 8000 EXERCISE TESTING SYSTEM (K991014)General Electric Medical Systems Information Techn1999-10-20
MAC SERIES ELECTROCARDIOGRAPHS INCLUDING MAC 5000, MAC PC, MAC 6, MAC VU, MAC 8 ELECTROCARDIOGRAPHS (K991735)General Electric Medical Systems Information Techn1999-08-19
NIHON KOHDEN ECG-9010K AND ECG-9020K CARDIOFAX GEM AND ACCESSORIES (K990031)Nihon Kohden America, Inc.1999-04-16
NIHON KOHDEN ECG-9110K AND ECG-9130K CARDIOFAX Q AND ACCESSORIES (K984504)Nihon Kohden America, Inc.1999-04-15
MICROMEDICAL 12 LEAD SIMULTANEOUS CABLE (K990266)Micromedical Industries, Ltd.1999-02-02
QT DISPERSION AND T WAVE ANALYSIS PROGRAM (QT GUARD ANALYSIS SYSTEM) (K981024)Marquette Medical Systems, Inc.1998-10-06
CARDIOVIEW 3000 SOFTWARE (K974352)Micromedical, Inc.1998-09-08
FUKUDA DENSHI: CARDIOMAX, MODEL FX-4010 MULTI CHANNEL ELECTROCARDIOGRAPH (K981066)Fukuda Denshi USA, Inc.1998-08-31
ELECTROCARDIOGRAPHS (K972587)Dr. Lee Co., Ltd.1998-08-21
PULSE BIOMEDICAL INC, QRS CARD S-T SEGMENT ANALYSIS MONITORING SYSTEM (K972255)Pulse Biomedical, Inc.1998-07-07
PAGEWRITER 200I INTERPRETIVE CARDIOGRAPH MODEL M1770A WITH ACUTE CARDIAC ISCHEMIA TIME INSENSITIVE PREDICTIVE INSTRUMENA (K981265)Hewlett-Packard Co.1998-06-23
MODEL M1792A THROMBOLYTIC PREDICTIVE INSTRUMENT (K974087)Hewlett-Packard Co.1998-06-15
ARCHIMED 4210 AND 4220 (K973922)Biosound Esaote, Inc.1998-05-12
MUSE CARDIOVASCULAR INFORMATION SYSTEM (K980495)Marquette Medical Systems, Inc.1998-05-07
CARDIOSMART ST (K973403)Marquette Medical Systems, Inc.1998-03-12
ACUTE CARDIAC ISCHEMIA TIME-INSENSITIVE PREDICTIVE INSTRUMENT (ACI-TIPI) OPTION (K974199)Marquette Medical Systems, Inc.1998-02-06
FUKUDA DENSHI MODEL FCP-2155 MULTI CHANNEL, INTERPRETIVE ELECTROCARDIOGRAPH (K971440)Fukuda Denshi USA, Inc.1997-12-02
CARDIOVIT CS-200 (K970879)Schiller America, Inc.1997-06-25
EAGLE 4000 PATIENT MONITOR (K964750)Marquette Electronics, Inc.1997-02-21
HARDWARE:CARDIO PERFECT PORTABLE, CARDIO PERFECT MD AND SOFTWARE:CARDIO PERFECT (V. 4.0 AND UP FOR DOS), CARDIO PERFECT (K962854)Cardio Control BV1997-01-27
MULTIPLE PARAMETER TELEMETRY, VITAL VIEW, & MICROVIEW SYSTEMS (K961223)Criticare Systems, Inc.1996-12-10
NIHON KOHDEN ECG-9320A CARDIOFAX AND ACCESSORIES (K961272)Nihon Kohden America, Inc.1996-11-01
QUINTON MODEL Q710 EXERCISE AND RESTING ELECTROCARDIOGRAPH (K961014)Quinton, Inc.1996-07-31
PAGEWRITER 200, 200I CARDIOGRAPH & INTERPRETIVE CARDIO (K954980)Hewlett-Packard Co.1996-05-15
ECLIPSE 4 ELECTROCARDIOGRAPH (K946281)Burdick, Inc.1996-04-23
CARDIOSOFT/CARDIOSYS (K951130)Marquette Electronics, Inc.1996-04-04
HEWLETT-PACKARD MODEL M1791A ACUTE CARDIAC ISCHEMIA-TIME INSENSITIVE PREDICITIVE INSTRUMENT (ACI-TIPT) (K951978)Hewlett-Packard Co.1996-01-04
CARDIOVIT AT-1C, AT-2C (K953396)Schiller America, Inc.1995-12-19
CENTRA HEART STATION (K935589)Marquette Electronics, Inc.1995-08-24
ECG FAX MODEM (K941282)Hewlett-Packard Co.1995-05-26
CARDIOVIT AT-5C (K941462)Schiller America, Inc.1995-05-19
ECLIPSE 4 ELECTROCARDIOGRAPH (K943959)Burdick, Inc.1995-05-17
HP M177XA CARDIOGRAPHS (K935772)Hewlett-Packard Co.1994-07-26
MODEL ELI 300 ELECTROCARDIOGRAPH (K933143)Mortara Instrument, Inc.1994-04-15
CARDIOFAX Q ECG-8420A (K922394)Nihon Kohden America, Inc.1994-03-01
SPACE LABS MODEL 90560 (K923788)Spacelabs, Inc.1993-12-06
CARDIO PERFECT, CARDIO PERFECT MD (K922898)Cardio Control BV1993-11-01
MARQUETTE SL SERIES TRANSPORT REMOTE ACQUISITION (K921669)Marquette Electronics, Inc.1993-05-07
SPRINT DX, MODEL 5400 EXERCISE STRESS TEST SYSTEM (K922221)Del Mar Avionics1993-04-21
MORTARA INSTRUMENT ODEL ELI 50I (K915730)Mortara Instrument, Inc.1992-11-10
CARDIOVIT CS-100 (K914970)Schiller America, Inc.1992-11-03
INTERP-1000 (K921476)Qmed, Inc.1992-10-21
ELITE II ELECTROCARDIOGRAPH,MODIFIED (K915327)Siemens Burdick, Inc.1992-10-09
MODEL ELI 200 ELECTROCARDIOGRAPH (K920626)Mortara Instrument, Inc.1992-09-04
MODEL ELI 100 ELECTROCARDIOGRAPH (K920627)Mortara Instrument, Inc.1992-09-04
SMI MODEL 210 AMBULATORY ECG MONITORING SYSTEM (K920294)Stuart Medical, Inc.1992-07-07
MEGACART (K915225)Siemens Burdick, Inc.1992-07-01
SPECTRA ECG (K915658)Advanced Medical Products, Inc.1992-06-10
INTERNAL MODEM FOR THE E560 ELECTROCARDIOGRAPH (K915202)Siemens Burdick, Inc.1992-05-15
MORTARA INSTRUMENT MODEL ECG PREVU (K920377)Mortara Instrument, Inc.1992-04-28
E350I ELECTROCARDIOGRAPH (K914969)Siemens Burdick, Inc.1992-03-26
LIKEPAK 11 CARDIAC MONIT/LIFENET RS100 REC STATION (K912189)Physio-Control Corp.1992-02-14
SERIES 1500 12-LEAD ANALYSIS OPTION (K903644)Marquette Electronics, Inc.1991-12-27
FUKUDA DENSHI MODEL FCP-4101 (K913811)Fukuda Denshi USA, Inc.1991-12-09
WEX MULTI DOMAIN CARDIAC SYSTEM (HD-3L) (K901619)Wex Medical Instrumentation Co.1991-09-05
ELITE II ELECTROCARDIOGRAPH (K904032)Burdick Corp.1991-07-24
E560 ELECTROCARDIOGRAPH (K903565)Burdick Corp.1991-07-24
SMALL JOINT INSTRUMENTS (SCISSOR HANDLE) (K903536)Leonard Medical, Inc.1990-09-06
PAGEWRITER XLI M1700A & PAGEWRITER XL M1701A (K895520)Hewlett-Packard Co.1990-07-17
CARDISUNY, 501BX (K900849)Graham-Field, Inc.1990-04-04
MODEL ELI-100/ST ELECTROCARDIOGRAPH (K895232)Mortara Instrument, Inc.1989-12-13
SPACELABS MODEL 90900 (K894093)Spacelabs, Inc.1989-11-30
FUKUDA DENSHI MODEL FCP-2201 (K892796)Fukuda Denshi USA, Inc.1989-10-02
HIGH RESOLUTION OPTION FOR MAC SERIES ELECTROCARDI (K884087)Marquette Electronics, Inc.1989-02-23
Q750 ELECTROCARDIOGRAPH (K885000)Quinton, Inc.1989-02-23
KENZ-CARDICO 1201 (K870443)Suzuken Co., Ltd.1987-07-01
MINGOGRAF 740 - MODEL #91-54-634 (K864575)Siemens Medical Solutions USA, Inc.1987-05-07
ELITE ELECTROCARDIOGRAPH (K870920)Burdick Corp.1987-04-13
CARDIO ANALYZER MODEL 380 (K844104)Birtcher Corp.1985-03-06
MODEL 503FB (K842759)Atrix1985-01-18
N-CHANNEL (K834212)Philips Medical Systems (Cleveland), Inc.1984-11-13
12SSL-SC (K842308)Marquette Electronics, Inc.1984-09-21
MARQUETTE OPTION II ECG ANALYSIS COMPUT (K820885)Marquette Electronics, Inc.1982-04-15
IBM 5880 ACQUISITION & ANALYSIS CART TEL (K810989)Intl. Business Machines1981-05-01
12SSL ECG ANALYSIS PROG.(SCALER LEAD) (K802369)Marquette Electronics, Inc.1980-11-12
EKG ACQUISITION & ANALYSIS CART (K772353)Intl. Business Machines1978-01-06

Track LOS automatically

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