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DSV Contract Logistics: FDA-registered device maker in Tijuana Baja California, Mexico, 96 510(k) clearances and 7 PMA approvals

DSV Contract Logistics is registered with the FDA (registration 3044156918) in Tijuana Baja California, Mexico. It lists 39 device types. The FDA files 96 510(k) clearances and 7 PMA approvals under its listings, the newest dated March 10, 2025. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

FDA registration number
3044156918
Address
Boulevard Corredor 2000 No. 25451, Colonia Fideicomiso El Florido, Tijuana Baja California, Mexico, 22245
Owner or operator
DSV Contract Logistics (10095650)
Roles
Exporter to the US
First device listed
April 9, 2026
Registered through
2026
Brand names listed
"Affinity CP Adapter Affinity CP Centrifugal Blood Pump Bio-Pump BP50 Emergency Hand Crank External Motor", "Affinity ECMO Intersept Minimax", "Affinity™ CP Centrifugal Blood Pump Medtronic External Drive Motor", "Arctic Front Advance cardiac cryoablation catheter Arctic Front Advance ProTM Freezor MAX cardiac cryoablation cathet, "Axium Detachable Coil System Axium Prime Detachable Coil System", "Axium Detachable Coil System Instant Detacher", "Axium™ Detachable Coil Axium™ Prime Detachable Coil", "CV-SH Cannulae, Fem Arterial 1-Piece, Bio-Medicus CV-SH Cannulae, Femoral Venous 1-Piece, BioMedicus" and more

Devices it lists

DeviceProduct codeClassRoleSource
Analyzer, Gas, Carbon-Dioxide, Gaseous-PhaseCCK2Exporter to the USaccessdata.fda.gov
Aortic Valve, Prosthesis, Percutaneously DeliveredNPT3Exporter to the USaccessdata.fda.gov
Apparatus, AutotransfusionCAC2Exporter to the USaccessdata.fda.gov
ArthroscopeHRX2Exporter to the USaccessdata.fda.gov
Cardiac Ablation Percutaneous CatheterLPB3Exporter to the USaccessdata.fda.gov
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassDWF2Exporter to the USaccessdata.fda.gov
Catheter, Continuous FlushKRA2Exporter to the USaccessdata.fda.gov
Catheter, Electrode Recording, Or Probe, Electrode RecordingDRF2Exporter to the USaccessdata.fda.gov
Catheter, PercutaneousDQY2Exporter to the USaccessdata.fda.gov
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial FibrillationOAE3Exporter to the USaccessdata.fda.gov
Catheter, Percutaneous, NeurovasculatureQJP2Exporter to the USaccessdata.fda.gov
Catheter, VentricularHCA2Exporter to the USaccessdata.fda.gov
Catheters, Transluminal Coronary Angioplasty, PercutaneousLOX2Exporter to the USaccessdata.fda.gov
Cement, Bone, VertebroplastyNDN2Exporter to the USaccessdata.fda.gov
Control, Pump Speed, Cardiopulmonary BypassDWA2Exporter to the USaccessdata.fda.gov
Defoamer, Cardiopulmonary BypassDTP2Exporter to the USaccessdata.fda.gov
Device, Monitoring, Intracranial PressureGWM2Exporter to the USaccessdata.fda.gov
Device, Neurovascular EmbolizationHCG2Exporter to the USaccessdata.fda.gov
Device, Vascular, For Promoting EmbolizationKRD2Exporter to the USaccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Exporter to the USaccessdata.fda.gov
External Cerebrospinal Fluid (Csf) DiversionPCB2Exporter to the USaccessdata.fda.gov
Filter, Blood, Cardiopulmonary Bypass, Arterial LineDTM2Exporter to the USaccessdata.fda.gov
Heart-Valve, Non-Allograft TissueLWR3Exporter to the USaccessdata.fda.gov
Heat-Exchanger, Cardiopulmonary BypassDTR2Exporter to the USaccessdata.fda.gov
Monitor, Blood-Gas, On-Line, Cardiopulmonary BypassDRY2Exporter to the USaccessdata.fda.gov
OximeterDQA2Exporter to the USaccessdata.fda.gov
Oximeter, EarDPZ2Exporter to the USaccessdata.fda.gov
Oxygenator, Cardiopulmonary BypassDTZ2Exporter to the USaccessdata.fda.gov
Probe, Blood-Flow, ExtravascularDPT2Exporter to the USaccessdata.fda.gov
Pulmonary Valve Prosthesis Percutaneously DeliveredNPVfExporter to the USaccessdata.fda.gov
Pump, Blood, Cardiopulmonary Bypass, Non-Roller TypeKFM2Exporter to the USaccessdata.fda.gov
Reservoir, Blood, Cardiopulmonary BypassDTN2Exporter to the USaccessdata.fda.gov
Ring, AnnuloplastyKRH2Exporter to the USaccessdata.fda.gov
Shunt, Central Nervous System And ComponentsJXG2Exporter to the USaccessdata.fda.gov
Single Lumen Ecmo CannulaQHW2Exporter to the USaccessdata.fda.gov
System, Thermal RegulatingDWJ2Exporter to the USaccessdata.fda.gov
TampHXG1Exporter to the USaccessdata.fda.gov
Tubing, Pump, Cardiopulmonary BypassDWE2Exporter to the USaccessdata.fda.gov
Ventilator, Continuous, Facility UseCBK2Exporter to the USaccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
March 10, 2025K243676Duet External Drainage and Monitoring System (EDMS)JXGSubstantially EquivalentMedtronic Neurosurgeryaccessdata.fda.gov
April 19, 2024K240534Bio-Medicus Life Support Catheter and IntroducerQHWSubstantially EquivalentMedtronic, Inc.accessdata.fda.gov
November 7, 2023K233420Axium Detachable Coil; Axium Prime Detachable CoilHCGSubstantially EquivalentMicro Therapeutics Lnc. D/B/A Ev3 Neurovascularaccessdata.fda.gov
August 22, 2023K2321906F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide CatheterDQYSubstantially EquivalentMedtronic Vascularaccessdata.fda.gov
June 30, 2023K2301565F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide CatheterDQYSubstantially EquivalentMedtronic Vascularaccessdata.fda.gov
January 14, 2022K201057Bio-Medicus Life Support Catheter and IntroducerQHWSubstantially EquivalentMedtronic, Inc.accessdata.fda.gov
July 7, 2021K203432Axium Detachable Coil; Axium Prime Detachable CoilHCGSubstantially EquivalentMicro Therapeutics, Inc. d/b/a ev3 Neurovascularaccessdata.fda.gov
February 25, 2021K210230Phenom CathetersDQYSubstantially EquivalentMicro Therapeutics Lnc. D/B/A Ev3 Neurovascularaccessdata.fda.gov
November 20, 2020K193056Puritan Bennett 980 Series Ventilator SystemCBKSubstantially EquivalentCovidien, LLCaccessdata.fda.gov
July 1, 2020K201449SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid Annuloplasty RingKRHSubstantially EquivalentMedtronic, Inc.accessdata.fda.gov
May 26, 2020K201118Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser LevelGWMSubstantially EquivalentMedtronic, Inc.accessdata.fda.gov
April 9, 2020K200630Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage BagsGWMSubstantially EquivalentMedtronic, Inc.accessdata.fda.gov
March 26, 2020K200456Becker External Drainage and Monitoring SystemGWMSubstantially EquivalentMedtronic, Inc.accessdata.fda.gov
August 27, 2019K191077Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortive BioActive Surface, Medtronic External Drive MotorKFMSubstantially EquivalentMedtronic, Inc.accessdata.fda.gov
May 29, 2018K181132Tri-Ad 2.0 Adams Tricuspid BandKRHSubstantially EquivalentMedtronicaccessdata.fda.gov
March 22, 2018K180456Bio-Medicus Adult Cannulae KitDWFSubstantially EquivalentMedtronic, Inc.accessdata.fda.gov
March 22, 2018K180453Bio-Medicus Adult Cannulae and IntroducerDWFSubstantially EquivalentMedtronic, Inc.accessdata.fda.gov
October 27, 2017K171979Tubing PackDWFSubstantially EquivalentMedtronic, Inc.accessdata.fda.gov
June 2, 2017K171308Tubing PackDWFSubstantially EquivalentMedtronic, Inc.accessdata.fda.gov
February 1, 2017K162958MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface; MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface with Bridge; MYOtherm XP Cardioplegia Delivery System; MYOtherm XP Cardioplegia Delivery System with BridgeDTRSubstantially EquivalentMedtronic, Inc.accessdata.fda.gov
January 3, 2017K162704Axium Prime Detachable Coil SystemHCGSubstantially EquivalentMicro Therapeutics, Inc. d/b/a ev3 Neurovascularaccessdata.fda.gov
March 29, 2016K151252Puritan Bennett 840 Series Ventilator SystemCBKSubstantially EquivalentCovidien LPaccessdata.fda.gov
January 15, 2016K153598Medtronic Bio-Medicus Adult Cannula KitDWFSubstantially EquivalentMedtronic, Inc.accessdata.fda.gov
July 28, 2015K151447Axium Detachable Coil SystemHCGSubstantially EquivalentMicro Therapeutics, Inc. d/b/a ev3 Neurovascularaccessdata.fda.gov
July 23, 2015K151532KYPHON ELEMENT Inflatable Bone TampHRXSubstantially EquivalentMedtronic, Inc.accessdata.fda.gov
May 27, 2015K151110Intersept Filtered Cardiotomy ReservoirDTNSubstantially EquivalentMedtronic, Inc.accessdata.fda.gov
April 9, 2015K150567MEDTRONIC BIO-MEDICUS CANNULA INSERTION KITDWFSubstantially EquivalentMedtronic, Inc.accessdata.fda.gov
March 25, 2015K143083Bio-Medicus Pediatric Cannula and IntroducersDWFSubstantially EquivalentMedtronic, Inc.accessdata.fda.gov
November 18, 2014K142673Bio-Medicus Adult Cannulae and IntroducerDWFSubstantially EquivalentMedtronic, Inc.accessdata.fda.gov
October 23, 2014K133157TRI-OPTIC MEASUREMENT CELL; WITH BALANCE BIOSURFACE, WITH CARMEDA BIOACTIVE SURFACE, WITH TRILLIUM BIOSURFACE, WITH 6DRYSubstantially EquivalentMedtronic, Inc.accessdata.fda.gov
August 22, 2014DEN120017Medtronic DUET External Drainage and Monitoring SystemPCBUnknownMedtronic Neurosurgeryaccessdata.fda.gov
August 15, 2014K141090NC EUPHORA RAPID EXCHANGE BALLOON DILATATION CATHETERLOXSubstantially EquivalentMedtronic, Inc.accessdata.fda.gov
May 30, 2014K132730BIO-PROBE DISPOSABLE INSERT WITH; BALANCE BIOSURFACE, CARMEDA BIOACTIVE SURFACE, TRILLIUM BIOSURFACEDPTSubstantially EquivalentMedtronic, Inc.accessdata.fda.gov
May 20, 2014K140165MC2 TWO-STAGE VENOUS CANNULA, OVAL MC2 TWO-STAGE VENOUS CANNULA, THIN WALL TWO-STAGE VENOUS CANNULA, MC2X THREE-STAGE VEDWFSubstantially EquivalentMedtronic, Inc.accessdata.fda.gov
January 10, 2014K133310AXIUM DETACHABLE COIL SYSTEMHCGSubstantially EquivalentMicro Therapeutics, Inc. d/b/a ev3 Neurovascularaccessdata.fda.gov
November 19, 2013K132712AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH OR WITHOUT COATING, AFFINITY CP ADAPTERKFMSubstantially EquivalentMedtronic, Inc.accessdata.fda.gov
July 29, 2013K131361WARMTOUCH SURGICAL ACCESS BLANKET, WARMTOUCH TORSO BLANKETDWJSubstantially EquivalentCovidienaccessdata.fda.gov
December 21, 2012K123771KYPHON EXPRESS II INFLATABLE BONE TAMPSHRXSubstantially EquivalentMedtronicaccessdata.fda.gov
October 19, 2012K122913AFFINITY FUSION RECIRCULATION LINE MODEL RCL841DWFSubstantially EquivalentMedtronic, Inc.accessdata.fda.gov
July 25, 2012K120988DLP SINGLE STAGE VENOUS CANNULA, DLP RIGHT ANGLE SINGLE STAGE VENOUS CANNULA, DLP SINGLE STAGE VENOUS CANNULA WITH RIGHTDWFSubstantially EquivalentMedtronic, Inc.accessdata.fda.gov
March 18, 2011K102588ACHIEVE MAPPING CATHETER AND ELECTRICAL CABLEDRFSubstantially EquivalentMedtronic Ablation Frontiers, LLCaccessdata.fda.gov
October 14, 2010K101864KYPHON XPANDER II INFLATABLE BONE TAMPHRXSubstantially EquivalentMedtronicaccessdata.fda.gov
August 7, 2010K101212MEDTRONIC CONTOUR 3D ANNULOPLASTY RING, MODEL 690RKRHSubstantially EquivalentMedtronic, Inc.accessdata.fda.gov
July 15, 2010K093903ATS TRI-AD SEMI-FLEXIBLE TRICUSPID ANUULOPLASTY, MODEL 900SFCKRHSubstantially EquivalentGenesee Biomedical, Inc.accessdata.fda.gov
March 22, 2010K093535AUTOLOG AUTOTRANSFUSION SYSTEMCACSubstantially EquivalentMedtronic, Inc.accessdata.fda.gov
September 18, 2009K091559MARKSMANN CATHETERKRASubstantially EquivalentChestnut Medical Technologies, Inc.accessdata.fda.gov
February 27, 2009K090046CONCERTO DETACHABLE COIL SYSTEMKRDSubstantially EquivalentMicro Therapeutics, Inc.accessdata.fda.gov
February 25, 2009K083683ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SCKRHSubstantially EquivalentGenesee Biomedical, Inc.accessdata.fda.gov
August 19, 2008K081465AXIUM DETACHABLE COIL SYSTEMKRDSubstantially EquivalentMicro Therapeutics, Inc.accessdata.fda.gov
March 13, 2008K073324MEDTRONIC PROFILE 3D ANNULOPLASTY RING, MODEL 680RKRHSubstantially EquivalentMedtronic, Inc.accessdata.fda.gov
October 23, 2007K072655ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SRKRHSubstantially EquivalentGenesee Biomedical, Inc.accessdata.fda.gov
July 3, 2007K071253AFFINITY PEDIATRIC ARTERIAL FILTER, MODEL S4014 AND WITH CARMEDA BIOACTIVE SURFACE, MODEL CB4014DTMSubstantially EquivalentMedtronic Vascularaccessdata.fda.gov
June 23, 2006K061254EOPA 3D ARTERIAL CANNULA, MODELS 78220,78222,78320,783222DWFSubstantially EquivalentMedtronic Perfusion Systemsaccessdata.fda.gov
November 17, 2005K052899ATS SIMULUS ANNULOPLASTY BAND, MODEL 700FCKRHSubstantially EquivalentGenesee Biomedical, Inc.accessdata.fda.gov
November 17, 2005K052565ATS SIMULUS ANNULOPLASTY RING, MODEL 700FFKRHSubstantially EquivalentGenesee Biomedical, Inc.accessdata.fda.gov
February 8, 2005K043179SELECT 3D ARTERIAL CANNULADWFSubstantially EquivalentMedtronic Perfusion Systemsaccessdata.fda.gov
July 9, 2004K041454KYPHX XPANDER INFLATABLE BONE TAMPS MODEL#KO8A,KO9A,K13AHRXSubstantially EquivalentKyphon, Inc.accessdata.fda.gov
October 31, 2003K033264MALLEABLE SINGLE STAGE VENOUS CANNULA WITH CARMEDA BIOACTIVE SURFACE, MODEL CB681XX SERIESDWFSubstantially EquivalentMedtronic Perfusion Systemsaccessdata.fda.gov
May 13, 2003K031037EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA AND GUIDEWIREDWFSubstantially EquivalentMedtronic Perfusion Systemsaccessdata.fda.gov
September 24, 2002K022819NELLCOR N-200 PULSE OXIMETER, MODEL N-200DQASubstantially EquivalentNellcor Puritan Bennett, Inc.accessdata.fda.gov
May 17, 2002K021256Z3 GUIDE CATHETERDQYSubstantially EquivalentMedtronic Vascularaccessdata.fda.gov
March 7, 2002K012891OXIMAX PULSE OXIMETRY SYSTEM WITH N-595 PULSE OXIMETER AND OXIMAX SENSORS AND CABLES (AKA ACCESSORIES)DQASubstantially EquivalentNellcor Puritan Bennett, Inc.accessdata.fda.gov
February 25, 2000K000430AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH CARMEDA BIOACTIVE SURFACE, MODEL CB511DTZSubstantially EquivalentMedtronic Vascularaccessdata.fda.gov
February 4, 1999K984053BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEMJXGSubstantially EquivalentMedtronic PS Medicalaccessdata.fda.gov
January 26, 1999K983799MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM, MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM POLE CLAMP, MEDTRONIC PS MEDICLGWMSubstantially EquivalentMedtronic PS Medicalaccessdata.fda.gov
February 25, 1998K973011BPX80 BIO-PUMP (BPX80)KFMSubstantially EquivalentMedtronic Bio-Medicus, Inc.accessdata.fda.gov
February 1, 1996K955836VALLEYLAB COATED ELECTRODESGEISubstantially EquivalentValleylab, Inc.accessdata.fda.gov
September 27, 1994K944400PEDI-CAPCCKSubstantially EquivalentNellcor, Inc.accessdata.fda.gov
May 17, 1994K942183E2550 REUSABLE HANDSWITCHING PENCILGEISubstantially EquivalentValleylab, Inc.accessdata.fda.gov
July 1, 1993K930154EL2-SERIES BLOOD COLLECTION REERVOIRDTNSubstantially EquivalentElectromedics, Inc.accessdata.fda.gov
June 23, 1993K924529SIGNATURE(TM) CUSTOM TUBING PACKDWFUnknownAvecor Cardiovascular, Inc.accessdata.fda.gov
June 22, 1993K926226INTERSEPT FILTERED CARDIOTOMY RESERVOIRDTZSubstantially EquivalentMedtronic Vascularaccessdata.fda.gov
March 26, 1993K924642MEDTRONIC BIO-MEDICUS FEMORAL CANNULA/INTRODUCERDWFSubstantially EquivalentMedtronic Bio-Medicus, Inc.accessdata.fda.gov
February 19, 1993K926250ELECTROMEDICS EL-SERIES CARDIOTOMY RESERVOIRDTNSubstantially EquivalentElectromedics, Inc.accessdata.fda.gov
September 4, 1991K913016WARMTOUCHDWJSubstantially EquivalentAdvanced Warming Systems, Inc.accessdata.fda.gov
December 27, 1990K904039REFLECTANCE SENSOR (RS-10)DQASubstantially EquivalentNellcor, Inc.accessdata.fda.gov
May 31, 1989K891687EXTRACORPOREAL CIRCUIT WITH BIO-ACTIVE SURFACEDTZSubstantially EquivalentMedtronic Blood Systems, Inc.accessdata.fda.gov
December 21, 1988K884129BIO-MEDICUS PERCUTANEOUS CANNULA & INTRODUCER SETDQYSubstantially EquivalentBio Medicus, Inc.accessdata.fda.gov
December 7, 1987K872033BIO-MEDICUS CANNULA-TUBINGDWFSubstantially EquivalentBio Medicus, Inc.accessdata.fda.gov
August 12, 1986K862303BECKER EXTERNAL DRAINAGE/MONITOR SYS LUMBAR CATH.JXGSubstantially EquivalentPudenz-Schulte Medical Research Corp.accessdata.fda.gov
September 30, 1985K852807BIO MEDICUS BIO PUMP MODEL BP-50KFMSubstantially EquivalentBio Medicus, Inc.accessdata.fda.gov
April 3, 1985K845045VENOUS RETURN CATHETER SS-1DWFSubstantially EquivalentDlp, Inc.accessdata.fda.gov
February 13, 1984K840002ARTERIAL CANNULA CURVED BEVELED TIPDWFSubstantially EquivalentDlp, Inc.accessdata.fda.gov
February 13, 1984K840001ARTERIAL CANNULA STRAIGHT BEVELED TIPDWFSubstantially EquivalentDlp, Inc.accessdata.fda.gov
January 3, 1984K834039INFANT VENT CATHETER 12001 W/SIDE VENTDWFSubstantially EquivalentDlp, Inc.accessdata.fda.gov
June 24, 1983K831678P-S MEDICAL CSF-FLOW CONTROL VALVE-BURJXGSubstantially EquivalentPudenz-Schulte Medical Research Corp.accessdata.fda.gov
May 2, 1983K830735BT 795/A AUTOTRANSCACSubstantially EquivalentElectromedics, Inc.accessdata.fda.gov
September 21, 1982K822572POLYHESIVE PATIENT RETURN ELECTRODEGEISubstantially EquivalentValleylab, Inc.accessdata.fda.gov
November 10, 1981K813071E2508 DISPOSABLE HANDSWITCHING PENCILGEISubstantially EquivalentValleylab, Inc.accessdata.fda.gov
October 23, 1981K812292AUTOTRANS BT795CACSubstantially EquivalentElectromedics, Inc.accessdata.fda.gov
March 17, 1981K810548CARDIOPULMINARY BYPASS CATHETER CANNULADWFSubstantially EquivalentDlp, Inc.accessdata.fda.gov
January 13, 1981K803277TYGON TUBINGDWESubstantially EquivalentElectromedics, Inc.accessdata.fda.gov
September 16, 1980K802100INTRACRANIAL PRESSURING MONITORING SYST.GWMSubstantially EquivalentPudenz-Schulte Medical Research Corp.accessdata.fda.gov
February 21, 1980K800178EXTRACORP.'S INTERSEPT CUS. TUBING PK.DWESubstantially EquivalentExtracorporeal Medical Specialities, Inc.accessdata.fda.gov
January 16, 1980K792007CSF-VENTRICULAR CATHETER, STANDARD DESJXGSubstantially EquivalentPudenz-Schulte Medical Research Corp.accessdata.fda.gov
June 11, 1979K790565AORTIC ROOT CANNULADWFSubstantially EquivalentDlp, Inc.accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
March 26, 2021P200046Harmony™ TPV SystemNPV51September 30, 2026accessdata.fda.gov
July 31, 2017P170006AVALUS(TM) BIOPROSTHESISLWR42July 9, 2026accessdata.fda.gov
January 27, 2015P140017MELODY TRANSCATHETER PULMONARY VALVE (TPV), ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM (DS)NPV33June 9, 2026accessdata.fda.gov
January 17, 2014P130021MEDTRONIC COREVALVE SYSTEMNPT182August 10, 2026accessdata.fda.gov
December 17, 2010P100010ARCTIC FRONT CRYOCATHETER SYSTEMOAE151September 25, 2026accessdata.fda.gov
April 17, 2003P0200457F FREEZOR CARDIAC CRYOABLATION CATHETER AND CCT.2 CRYOCONSOLE SYSTEMLPB102April 23, 2026accessdata.fda.gov
March 24, 1980P790017USCI DILATATION CATHETERLOX86October 27, 2010accessdata.fda.gov

Compare with other makers

Updated September 30, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.