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Data / Medical devices / Netherlands / Applied Medical Europe

Applied Medical Europe: FDA-registered device maker in Amersfoort Utrecht, Netherlands, 54 510(k) clearances

Applied Medical Europe is registered with the FDA (registration 3009763019) in Amersfoort Utrecht, Netherlands. It lists 24 device types. The FDA files 54 510(k) clearances under its listings, the newest dated March 31, 2022. 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.

Get makers like this oneWatch Applied Medical Europe
FDA registration number
3009763019
Address
Wiekenweg 21, Amersfoort Utrecht, Netherlands, 3815 KL
Owner or operator
APPLIED MEDICAL RESOURCES (2027111)
Roles
Exporter to the US, Manufacturer
First device listed
April 18, 2000
Registered through
2026
Brand names listed
GelPOINT Path Transanal Access Platform

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, Catheter, G-UKNY2Exporter to the USaccessdata.fda.gov
Adaptor, Bulbs, Miscellaneous, For EndoscopeFFY1Exporter to the USaccessdata.fda.gov
Adaptor, Ureteral CatheterEYI1Exporter to the USaccessdata.fda.gov
Anoscope And AccessoriesFER2Exporter to the USaccessdata.fda.gov
Catheter, Ureteral, Gastro-UrologyEYB2Exporter to the USaccessdata.fda.gov
Clamp, VascularDXC2Exporter to the USaccessdata.fda.gov
Clip, ImplantableFZP2Exporter to the USaccessdata.fda.gov
Clip, VascularDSS2Exporter to the USaccessdata.fda.gov
Culdoscope (And Accessories)HEW2Exporter to the USaccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Exporter to the USaccessdata.fda.gov
Endoscope Channel AccessoryODC2Exporter to the USaccessdata.fda.gov
Endoscopic Access Overtube, Gastroenterology-UrologyFED2Exporter to the USaccessdata.fda.gov
Injector And Syringe, AngiographicDXT2Exporter to the USaccessdata.fda.gov
Instrument, Manual, Specialized Obstetric-GynecologicKNA2Exporter to the USaccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Exporter to the USaccessdata.fda.gov
Instruments, Surgical, CardiovascularDWS1Exporter to the USaccessdata.fda.gov
Laparoscope, General & Plastic SurgeryGCJ2Exporter to the USaccessdata.fda.gov
Laparoscope, Gynecologic (And Accessories)HET2Exporter to the USaccessdata.fda.gov
Laparoscopic Accessories, GynecologicNWV1Exporter to the USaccessdata.fda.gov
Ring (Wound Protector), Drape Retention, InternalKGW2Exporter to the US, Manufactureraccessdata.fda.gov
Stent, UreteralFAD2Exporter to the USaccessdata.fda.gov
Stents, Drains And Dilators For The Biliary DuctsFGE2Exporter to the USaccessdata.fda.gov
Stylet For Catheter, Gastro-UrologyEZB1Exporter to the USaccessdata.fda.gov
System, Evacuator, FluidFHF2Exporter 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 31, 2022K211043Alexis Contained Extraction SystemGCJSubstantially EquivalentApplied Medical Resources Corporationaccessdata.fda.gov
September 6, 2019K191294Transvaginal Access PlatformHEWSubstantially EquivalentApplied Medical Resources Corp.accessdata.fda.gov
November 14, 2018K182653Voyant Maryland Fusion DeviceGEISubstantially EquivalentApplied Medical Resources Corp.accessdata.fda.gov
October 11, 2018K182244Voyant Electrosurgical GeneratorGEISubstantially EquivalentApplied Medical Resources Corp.accessdata.fda.gov
April 13, 2018K180699Voyant Open Fusion DeviceGEISubstantially EquivalentApplied Medical Resources Corporationaccessdata.fda.gov
February 13, 2018K172624Voyant 5mm Fusion DeviceGEISubstantially EquivalentApplied Medical Resources Corporationaccessdata.fda.gov
August 7, 2017K171684Epix Electrosurgical Probe with Smoke EvacuationGEISubstantially EquivalentApplied Medical Resources Corporationaccessdata.fda.gov
July 20, 2017K171701GelPOINT Path Transanal Access PlatformFERSubstantially EquivalentApplied Medical Resources Corp.accessdata.fda.gov
July 6, 2016K153017Voyant Fine FusionGEISubstantially EquivalentApplied Medical Resourcesaccessdata.fda.gov
December 23, 2014K142427TISSUE CONTAINMENT SYSTEM; 10, 14, 17, 25GCJSubstantially EquivalentApplied Medical Resourcesaccessdata.fda.gov
August 22, 2014K141288VOYANT ELECTROSURGICAL GENERATOR, VOYANT 5MM LAPAROSCOPIC SEALER-DIVIDER DEVICEGEISubstantially EquivalentApplied Medical Resourcesaccessdata.fda.gov
January 24, 2014K132300EPIX ELECTROSURGICAL PROBE SPATULA TIP, EPIX ELECTROSURGICAL PROBE L-HOOK TIP, EPIX ELECTROSURGICAL PROBE J-HOOK TIP, REGEISubstantially EquivalentApplied Medical Resources Corp.accessdata.fda.gov
January 2, 2014K133393GELPOINT PATH TRANSANAL ACCESS PLATFORMFERSubstantially EquivalentApplied Medical Resources Corp.accessdata.fda.gov
November 16, 2010K103282LAPAROSCOPIC DISSECTORGEISubstantially EquivalentApplied Medical Resources Corp.accessdata.fda.gov
April 22, 2010K100959SPECIMEN RETRIEVAL SYSTEMGCJSubstantially EquivalentApplied Medical Resourcesaccessdata.fda.gov
February 18, 2009K090275GELPORT SINGLE INCISION ACCESS SYSTEMGCJSubstantially EquivalentApplied Medical Resources Corp.accessdata.fda.gov
December 23, 2008K083638FIXATION TROCARSGCJSubstantially EquivalentApplied Medical Resources Corp.accessdata.fda.gov
October 5, 2007K072674KII TROCAR SYSTEMGCJSubstantially EquivalentApplied Medical Resources Corp.accessdata.fda.gov
January 9, 2007K062907ALEXIS WOUND RETRACTORKGWSubstantially EquivalentApplied Medical Resourcesaccessdata.fda.gov
August 24, 2006K062169APPLIED LAPAROSCOPIC DISPOSABLE MONOPOLAR SCISSORSHETSubstantially EquivalentApplied Medical Resources Corp.accessdata.fda.gov
April 7, 2006K060629GELPORT BLUNT TIP TROCAR SYSTEMGCJSubstantially EquivalentApplied Medical Resources Corp.accessdata.fda.gov
March 29, 2006K060673PEDIATRIC URETERAL STENTFADSubstantially EquivalentApplied Medical Resources Corp.accessdata.fda.gov
March 13, 2006K060534INTUITIVE SURGICAL SEALGCJSubstantially EquivalentApplied Medical Resources Corp.accessdata.fda.gov
January 24, 2006K060096MODULAR TROCAR SYSTEMGCJSubstantially EquivalentApplied Medical Resources Corp.accessdata.fda.gov
January 19, 2006K060051SPECIMEN RETRIEVAL SYSTEMGCJSubstantially EquivalentApplied Medical Resources Corp.accessdata.fda.gov
October 15, 2004K040760MODIFICATION TO URETERAL STENTFADSubstantially EquivalentApplied Medical Resources Corp.accessdata.fda.gov
September 14, 2004K041795MODIFICATION TO OPTICAL SEPARATOR SYSTEMGCJSubstantially EquivalentApplied Medical Resources Corp.accessdata.fda.gov
March 12, 2004K040295APPLIED LAPAROSCOPIC MONOPOLAR SCISSORSHETSubstantially EquivalentApplied Medical Resources Corp.accessdata.fda.gov
October 2, 2003K032889OPTICAL SEPARATORGCJSubstantially EquivalentApplied Medical Resourcesaccessdata.fda.gov
May 23, 2003K030642DEFLECTING URETERAL ACCESS SHEATHFEDSubstantially EquivalentApplied Medical Resources Corp.accessdata.fda.gov
February 28, 2002K014047APPLIED GELPORT LAPAROSCOPIC HAND ACCESS DEVICEGCJSubstantially EquivalentApplied Medical Resources Corp.accessdata.fda.gov
May 14, 2001K011236MODIFICATION TO IMPLANTABLE CLIPFZPSubstantially EquivalentApplied Medical Resources Corp.accessdata.fda.gov
February 1, 2001K003443SUCTION IRRIGATORFHFSubstantially EquivalentApplied Medicalaccessdata.fda.gov
January 8, 2001K002915FLEXIBLE OCCLUSION SYSTEMDXCSubstantially EquivalentApplied Medicalaccessdata.fda.gov
December 28, 1999K993650URETERAL ACCESS SHEATH SET - NEW MODELSFEDSubstantially EquivalentApplied Medical Resourcesaccessdata.fda.gov
June 21, 1999K991219C-FLEX URETERAL STENTSFADSubstantially EquivalentApplied Medical Resourcesaccessdata.fda.gov
November 4, 1996K962668AMR-ACV CLAMPSDXCSubstantially EquivalentApplied Medical Resourcesaccessdata.fda.gov
September 24, 1996K963359INSUFFLATION NEEDLEHETSubstantially EquivalentApplied Medical Resourcesaccessdata.fda.gov
May 8, 1995K950492ATRAUMAX SURGICAL CLAMPDXCSubstantially EquivalentApplied Medical Resourcesaccessdata.fda.gov
September 21, 1994K944135UROLOGICAL GUIDWIREKNYSubstantially EquivalentApplied Medical Resourcesaccessdata.fda.gov
August 9, 1994K943489DISPOSABLE SURGICAL TROCARGCJSubstantially EquivalentApplied Medical Resourcesaccessdata.fda.gov
April 18, 1994K941012LOW PRESSURE TAMPONADE BALLOON CATHETEREYBSubstantially EquivalentApplied Medical Resourcesaccessdata.fda.gov
November 5, 1993K923636TROCAR W/ BLUNT TIP OBTURATORHETSubstantially EquivalentApplied Medical Resourcesaccessdata.fda.gov
September 23, 1993K932995SURGICAL TROCAR AND CANNULAGCJSubstantially EquivalentApplied Medical Resourcesaccessdata.fda.gov
September 7, 1993K931895ENDOSCOPE ACCESSORYGCJSubstantially EquivalentApplied Medical Resourcesaccessdata.fda.gov
March 18, 1992K920030SURESEAL ENDOSCOPIC VALVEODCSubstantially EquivalentApplied Urology, Inc.accessdata.fda.gov
March 21, 1991K905738OPERATIVE CHOLANGIOGRAPHIC CATHETERFGESubstantially EquivalentApplied Vascular Devices, Inc.accessdata.fda.gov
July 6, 1990K901628APPLIED VASCULAR DEVICES 6MM TRACTION CLIPDXCSubstantially EquivalentApplied Vascular Devices, Inc.accessdata.fda.gov
June 12, 1990K901565ATRAUMAX SURGICAL CLAMP MODEL FOG-5048, 75MM SIDEDXCSubstantially EquivalentApplied Vascular Devices, Inc.accessdata.fda.gov
December 13, 1989K895691VASCULAR CLAMPDXCSubstantially EquivalentApplied Vascular Devices, Inc.accessdata.fda.gov
June 7, 1989K891296ATRAUMAX(TM) SURGICAL CLAMPSDXCSubstantially EquivalentApplied Vascular Devices, Inc.accessdata.fda.gov
December 27, 1988K883909SURGICAL SPRING CLIPSDSSSubstantially EquivalentApplied Vascular Devices, Inc.accessdata.fda.gov
December 27, 1988K883790SURGICAL CLAMP INSERTSDXCSubstantially EquivalentApplied Vascular Devices, Inc.accessdata.fda.gov
May 13, 1988K880987INJECTOR HANDLE WITH SYRINGEDXTSubstantially EquivalentApplied Vascular Devices, Inc.accessdata.fda.gov

Compare with other makers

Updated March 31, 2022. 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.