FDA.reportPublic FDA data

Phillips-Medisize Costa Mesa LLC

Matched from indexed company URL: Phillips Company

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
21349443004058281PHILLIPS-MEDISIZE, LLC1N2026-01-01705 Wisconsin Dr New Richmond WI US 54017
30033873843003387384Phillips Precision Inc1N2026-01-017 Paul Kohner Pl Elmwood Park NJ US 07407
30041835183004183518PHILLIPS SAFETY PRODUCTS, INC.1N2026-01-01123 Lincoln Blvd. Middlesex NJ US 08846
30130251773013025177Phillips-Medisize Healthcare (Suzhou) CO., LTD1N2026-01-01No. 16 Ruipu Road, Suzhou Industrial Park Suzhou Pilot Free Trade Zone Suzhou Jiangsu CN 215000
21349453002919960PHILLIPS-MEDISIZE, LLC,1N2020-04-25415 Red Cedar St 428 Technology Drive Menomonie WI US 54751
30155371593015537159PHILLIPS-MEDISIZE, LLC1N2020-04-251203 Beaudry Blvd Hudson WI US 54016

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
05713495000121SKYTROFA Auto-Injector - The SKYTROFA Auto-Injector is intended to automate the reconstitution (mixing) and subcutaneous (under the skin) injection of lonapegsomatropin in patients prescribed once weekly growth hormone therapy.1-844-442-7236JDW@AscendisPharma.com
05713495000138SKYTROFA Auto-Injector - The SKYTROFA Auto-Injector is intended to automate the reconstitution (mixing) and subcutaneous (under the skin) injection of lonapegsomatropin in patients prescribed once weekly growth hormone therapy.1-844-442-7236JDW@AscendisPharma.com
05713495000152VYAFUSER™ - The VYAFUSER™ Pump is an ambulatory infusion pump intended for the subcutaneous delivery of VYALEV(866) 489-2538GPODuopa@abbvie.com
05713495001043VYAFUSER™ - The VYAFUSER™ Pump is an ambulatory infusion pump intended for the subcutaneous delivery of VYALEV(866) 489-2538GPODuopa@abbvie.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
61901734412441P030006PROLIEVE THERMODILATATION SYSTEMMEQ2004-02-19
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
61891919532936K982842HUMAPEN AND HUMAPEN ERGOFMF1998-09-25
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
2326812010034264K173332OMNI Surgical SystemMRH2017-12-21
728261485529365K161838Xenocor Xenoscope Laparoscopic SystemGCJ2016-09-26
728261790723898K143675FORE-SIGHT Elite Absolute Tissue OximeterMUD2015-04-10
61891210211485K142518HumaPen LuxuraFMF2015-06-05
61901610644280K142374ivWatch Model 400MRZ2015-02-13
728262024236711K112478VISI MOBILE MONITORING SYSTEMMWI2012-03-22
728261434356116K111705EKOSONIC ENDOVASCULAR SYSTEMQEY2011-08-03
61901772639345K111517PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATIKZE2011-07-27
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
61891071259149K100988HUMAPEN LUXURA HDFMF2010-08-17
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
61901370948596K023388MITEK RAPIDLOC-PDS MENISCAL REPAIR SYSTEMJDR2002-12-27
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
61901388455942
61901502720892
2379781502720892
728261525134471
728261639002228
728261749685229
728262061157399
728262069599846
1492961030882140
728261034072591
1492961035457777
1492961045029099
1492961059591593
1492961065903756
1492961066205209
1492961072190260
1492961072617481
1492961074162203
890561077139073
1492961109313614
1492961112361391
1492961117314146
1492961124724318
1492961141816132
1492961144037325
1492961158778567
728261159888238
1492961191570328
890561193978724
1492961195210335
1492961206175475
728261220449228
1492961225556271
1492961226795142
1492961249205815
1492961255770509
1492961260331588
1492961271042880
1492961321421437
890561324402035
1492961351078627
1492961352742145
1492961354332536
1492961357080738
728261370588673
1492961376081395
1492961383094638
1492961385139121
728261394992549
1492961407351046
1492961408312129
1492961416587657

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MWJ62010-12-09
FMF32015-06-05
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
MRH12017-12-21
GCJ12016-09-26
MUD12015-04-10
MRZ12015-02-13
KZE12011-07-27
HBE12008-10-17
LJT12008-09-23
CAW12008-08-25
PFW12008-08-22
LLZ12008-06-12
GWN12007-09-18
DRS12006-02-17
MLO12005-09-26
MEQ12004-02-19
LIH12003-11-14
CCK12003-08-19
JDR12002-12-27
KWZ12002-10-25
DRF11999-11-05
DQA11998-08-20
FLS11996-02-02
LXH11995-04-13
BTY11994-11-22
DXO11993-10-18

PMN#

GUDID#