FDA.reportPublic FDA data

Phillips-Medisize Costa Mesa LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20310443001236763Phillips-Medisize Costa Mesa LLC1N2026-01-013545 Harbor Blvd Ste 150 Costa Mesa CA US 92626

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
728262050724827P000020STINGER ABLATION CATHETER; TEMPLINK EXTENSION CABLELPB2000-11-29
728261295066401K993618DXP1000 HOLTER RECORDERMWJ1999-11-24
728261883805352K993617DIGITRAKPLUS HOLTER RECORDERMWJ1999-11-24
728261708433704K992788BEAR CUB 750 PSVCBK1999-09-16
728261622618679K992373ORBITER ST DIAGNOSTIC ELECTRODE CATHETER & ORBITER ST EXTENSION CABLEDRF1999-11-05
728261010879435K981939AUTOCORR PLUS; 3404 OXIMETER/ECG MONITORDQA1998-08-20
728261430827944K981394BRAEMAR ER700 SERIES AMBULATORY ECG EVENT MONITOR MODELS ER710,ER720DXH1998-09-28
728261963093305K980806AFFINITY MEDICAL PATIENT CABLE SYSTEMDSA1998-03-25
728262004509454K980582MULTI-LINK CABLE AND LEAD WIRE SYSTEMSDSA1998-03-16
728261674581620K955816VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY (CCO/SVO2) MONITORDYG1997-05-06
728262060099485K951246PROPAQ ENCORE 200 SERIES MONITOR WITH NEONATAL MODE AND IMPEDANCE PNEUMOGRAPHY OPTIONSFLS1996-02-02
728261689925840K945130BRAEMAR MODEL DL700 AMBULATORY ELECTROCARDIOGRAPHIC RECORDERDSH1995-04-12
728261213740160K945071PROPAQ 200 MONITORDRT1995-05-10
728261572403276K944188SPINAL MARKERLXH1995-04-13
728261473372830K942211VMAX229 SERIES PULMONARY/METABOLIC SYSTEMSBTY1994-11-22
728261450871885K925638PHOENIX DISPOSABLE PRESSURE TRANSDUCER #73-600DXO1993-10-18
728261606248156K903331ROZINN 151DSH1990-10-22
728261673104780K895719TELEREHAB SYSTEM FOR CARDIAC REHABILITATIONDXH1990-03-06
728261652535558K822723SWAN-GANZ BIPOLAR PACING CATHETERDYG1982-10-15
728261643334284K791183SWAN-GANZ FLOW-DIRECTED CATHETERLDF1979-07-12
728261485529365K161838Xenocor Xenoscope Laparoscopic SystemGCJ2016-09-26
728261790723898K143675FORE-SIGHT Elite Absolute Tissue OximeterMUD2015-04-10
728262024236711K112478VISI MOBILE MONITORING SYSTEMMWI2012-03-22
728261434356116K111705EKOSONIC ENDOVASCULAR SYSTEMQEY2011-08-03
728261612141607K111160INTRICON DATRIX CENTAURI MT AMBULATORY PATIENT ECG TELEMETRY SYSTEM (APETS)DSI2011-08-01
728261366121061K103211AVEA VENTILATORCBK2011-05-12
728261719187421K102723MODEL 950-12L HOLTER RECORDER WITHOUT ANALYSISMWJ2010-12-09
728261728297984K101619WELCH ALLYN 1500 PATIENT MONITORMHX2010-11-12
728261038081585K093288CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTIONQYX2010-04-08
728261458797015K092947TELESENTRY, MODEL TS01DSI2010-02-26
728261739038780K082173Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4SDPS2008-08-26
728261541301536K081475ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONSOLE (IPC)]HBE2008-10-17
728261772521268K081473HERO, VERSION 2.0DPS2008-06-27
728261319201803K081472SMARTPORT CT VORTEX; LP TITANIUM, SINGLE PLASTIC, SINGLE TITANIUM, TRIUMPH LOW PROFILE TITANIUM PORTSLJT2008-09-23
728261207030998K081471ECARD AND CCARDDXH2008-06-24
728261072991723K081469SECTRA WORKSTATION, IDS7 VERSION 11.3, IDS5 VERSION 11.1 P2LLZ2008-06-12
728261418422323K081468DEVILBISS PORTABLE OXYGEN CONCENTRATOR, 306 SERIESCAW2008-08-25
728261321855477K081467EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATIONQEY2008-06-26
728261133873529K081444BRAEMAR FUSION WIRELESS - AMBULATORY ECG ARRHYTHMIA MONITORING SYSTEMDSI2008-07-31
728261856408617K081075PAINSHIELD MDPFW2008-08-22
728261897299231K072008BRAEMAR ER900 WIRELESS SERIES ARRHYTHMIA EVENT RECORDERDRG2007-10-03
728261949366828K071733DL900 SERIES HOLTER RECORDERMWJ2007-07-24
728261350230409K070670EYETRACKER/IDEASGWN2007-09-18
728261335822007K063222CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1004QYX2006-11-14
728261485724467K052828DISPOSABLE TRANSPAC III INTEGRATED TRANSDUCER (IT)DRS2006-02-17
728261221516713K051730MATRIX HOLTER SYSTEM, MODEL M12MLO2005-09-26
728261797768952K050778TELEREHAD 2004DRG2005-04-13
728262069452565K041607QUINTON Q-TE; RMSMHX2004-07-16
728261764791706K040637POWERHEART AED G3 PROMKJ2004-08-06
728261860064188K033378VITAL SIGNS MONITOR, PROPAQ LTMWI2004-03-01
728261230320508K033358CHRONIC PAIN SUPPRESSOR CPS-2000, MODEL CPS-2000LIH2003-11-14
728261261279927K032466SPIDERVIEWMWJ2003-08-22
728261702340914K030856ER800 SERIES ECG EVENT RECORDERMWJ2003-03-28
728261026633410K030407ADVISOR, MODEL 9200CCK2003-08-19
728261157044437K021661RINGLOC CONSTRAINED LINERSKWZ2002-10-25
728261666961286K013598REUSE CLAIM FOR THE BARD ELECTROPHYSIOLOGY SURELINK, TEMPLINK, AND TEMPLINK M EXTENSION CABLESDSA2002-01-11
728261070761880K013425HEARTSTREAM/HEARTSTART FR2 AED ECG CABLE, MODELS M3860A, M3861A, M3840A, M3841AMKJ2002-01-14
728261095256481K012451PROPAQ ENCORE MODELS 202, 204, 206; PROPAQ CS MODELS 242, 244, 246DRT2001-08-20
728261071597046K002725MICROPAQ, MODELS 402 AND 404DRT2000-11-21
728261204698558
728261525134471
728261639002228
728261749685229
728262061157399
728262069599846
728261034072591
728261159888238
728261220449228
728261370588673
728261394992549
728261556660951
728261572556718
728261666961286
728261917597810
728261952863366
728262039866216
728262054357164

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MWJ62010-12-09
DSI32011-08-01
DXH32008-06-24
DSA32002-01-11
DRT32001-08-20
MWI22012-03-22
QEY22011-08-03
CBK22011-05-12
MHX22010-11-12
QYX22010-04-08
DPS22008-08-26
DRG22007-10-03
MKJ22004-08-06
DYG21997-05-06
DSH21995-04-12
GCJ12016-09-26
MUD12015-04-10
HBE12008-10-17
LJT12008-09-23
CAW12008-08-25
PFW12008-08-22
LLZ12008-06-12
GWN12007-09-18
DRS12006-02-17
MLO12005-09-26
LIH12003-11-14
CCK12003-08-19
KWZ12002-10-25
DRF11999-11-05
DQA11998-08-20
FLS11996-02-02
LXH11995-04-13
BTY11994-11-22
DXO11993-10-18
LDF11979-07-12