Applied Medical Resources

FDA Filings

This page includes the latest FDA filings for Applied Medical Resources. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Applied Medical Resources holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number3009763019
FEI Number3009763019
NameApplied Medical Europe
Owner & OperatorAPPLIED MEDICAL RESOURCES
Contact Address22872 AVENIDA EMPRESA --
Rancho Santa Margarita CA 92688 US
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressWiekenweg 21
Amersfoort Utrecht, 3815 KL NL
Establishment TypeExport Device to the United States But Perform No Other Operation on Device



Registration Number3009051888
FEI Number3009051888
NameApplied Medical Distribution Center
Owner & OperatorAPPLIED MEDICAL RESOURCES
Contact Address22872 AVENIDA EMPRESA --
Rancho Santa Margarita CA 92688 US
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address9401 Toledo Way
Irvine, CA 92618 US
Establishment Type
  • Manufacture Medical Device
  • Remanufacture Medical Device
  • Manufacture Device in the United States for Export Only



Registration Number2027111
FEI Number2027111
NameAPPLIED MEDICAL RESOURCES CORP.
Owner & OperatorAPPLIED MEDICAL RESOURCES
Contact Address22872 AVENIDA EMPRESA --
Rancho Santa Margarita CA 92688 US
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address22872 AVENIDA EMPRESA
RANCHO SANTA MARGARITA, CA 92688 US
Establishment Type
  • Complaint File Establishment per 21 CFR 820.198
  • Manufacture Device in the United States for Export Only



FDA Filings

Device
Company
DeviceDate
Applied Medical Resources
Applied Medical Anoscope2021-01-06
Applied Medical Europe [APPLIED MEDICAL RESOURCES]
GelPOINT Path Transanal Access Platform2017-12-11
Applied Medical Distribution Center [APPLIED MEDICAL RESOURCES]
GelPOINT Path Transanal Access Platform2017-12-11
APPLIED MEDICAL RESOURCES CORP. [APPLIED MEDICAL RESOURCES]
GelPOINT Path Transanal Access Platform2017-12-11
Applied Medical Resources
Voyant Open Fusion Device2016-12-01
APPLIED MEDICAL RESOURCES
Voyant Fine Fusion2016-07-06
APPLIED MEDICAL RESOURCES
Voyant Open Fusion Device2016-06-01
APPLIED MEDICAL RESOURCES
Epix Electrosurgical Probe With Smoke Evacuation2016-02-19
Applied Medical Europe [APPLIED MEDICAL RESOURCES]
GelPOINT Tansvaginal Access Platform2015-12-22
Applied Medical Distribution Center [APPLIED MEDICAL RESOURCES]
GelPOINT Tansvaginal Access Platform2015-12-22
APPLIED MEDICAL RESOURCES CORP. [APPLIED MEDICAL RESOURCES]
GelPOINT Tansvaginal Access Platform2015-12-22
APPLIED MEDICAL RESOURCES
GelPOINT Transvaginal Access Platform2015-10-13
APPLIED MEDICAL RESOURCES
Voyant Fine Fusion Device2015-04-16
APPLIED MEDICAL RESOURCES
Voyant Open Sealer-Divider Device2015-03-27
APPLIED MEDICAL RESOURCES
TISSUE CONTAINMENT SYSTEM; 10, 14, 17, 252014-12-23
APPLIED MEDICAL RESOURCES
VOYANT ELECTROSURGICAL GENERATOR, VOYANT 5MM LAPAROSCOPIC SEALER-DIVIDER DEVICE2014-08-22
APPLIED MEDICAL RESOURCES
SPECIMEN RETRIEVAL SYSTEM2010-04-22
APPLIED MEDICAL RESOURCES
ALEXIS WOUND RETRACTOR2007-01-09
APPLIED MEDICAL RESOURCES
OPTICAL SEPARATOR2003-10-02
APPLIED MEDICAL RESOURCES
SENTRY EXPANDING INTRODUCER SHEATH (EIS)2000-05-02
APPLIED MEDICAL RESOURCES
URETERAL ACCESS SHEATH SET - NEW MODELS1999-12-28
APPLIED MEDICAL RESOURCES
IMPLANTABLE CLIP FOR GENERAL SURGERY1999-12-01
APPLIED MEDICAL RESOURCES
SUTURE CLINCH1999-11-22
APPLIED MEDICAL RESOURCES
C-FLEX URETERAL STENTS1999-06-21
APPLIED MEDICAL RESOURCES
CYSTIC DUCT BALLOON DILATING CATHETER1999-05-05
APPLIED MEDICAL RESOURCES
URETERAL ACCESS SHEATH SET1999-04-21
APPLIED MEDICAL RESOURCES
MCAS (MODULAR CLIP APPLIER SYSTEM)1999-01-21
APPLIED MEDICAL RESOURCES
LATIS GRAFT CLEANING CATHETER1998-02-19
APPLIED MEDICAL RESOURCES
LAPAROSCOPIC GASTROSTOMY KIT1998-01-12
APPLIED MEDICAL RESOURCES
AMR MINI-LAPAROSCOPE1997-08-06
APPLIED MEDICAL RESOURCES
APPLIED MEDICAL LAPAROSCOPIC GUIDEWIRE1997-05-05
APPLIED MEDICAL RESOURCES
EVS1997-04-24
APPLIED MEDICAL RESOURCES
DUAL LUMEN EMBOLECTOMY CATHETER1997-03-28
APPLIED MEDICAL RESOURCES
APPLIED MEDICAL CLIP APPLIER1997-01-22
APPLIED MEDICAL RESOURCES
AMR-ACV CLAMPS1996-11-04
APPLIED MEDICAL RESOURCES
INSUFFLATION NEEDLE1996-09-24
APPLIED MEDICAL RESOURCES
SPECIMEN RETRIEVAL BAG1996-07-05
APPLIED MEDICAL RESOURCES
APPLIED MEDICAL 1.5MM REUSABLE ANGIOSCOPE1995-07-11
APPLIED MEDICAL RESOURCES
LAPAROSCOPIC CLAMP1995-05-25
APPLIED MEDICAL RESOURCES
AVD INTIMAX THROMBECTOMY CATHETER1995-05-15
APPLIED MEDICAL RESOURCES
ATRAUMAX SURGICAL CLAMP1995-05-08
APPLIED MEDICAL RESOURCES
TROCAR AND CANNULA ACCESSORY1995-02-28
APPLIED MEDICAL RESOURCES
APPLIED MEDICAL OPTICAL VALVULOTOME1995-02-10
APPLIED MEDICAL RESOURCES
URETHRAL SUTURE GUIDE1995-01-31
APPLIED MEDICAL RESOURCES
FLEXIBLE LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER1994-11-29
APPLIED MEDICAL RESOURCES
UROLOGICAL GUIDWIRE1994-09-21
APPLIED MEDICAL RESOURCES
DISPOSABLE SURGICAL TROCAR1994-08-09
APPLIED MEDICAL RESOURCES
ACU-SIZER(TM)1994-06-13
APPLIED MEDICAL RESOURCES
LOW PRESSURE TAMPONADE BALLOON CATHETER1994-04-18
APPLIED MEDICAL RESOURCES
ACUCISE GUIDEWIRE EXCHANGE SHEATH1994-04-18
APPLIED MEDICAL RESOURCES
EXTERNAL VEIN STRIPPER1994-03-23
APPLIED MEDICAL RESOURCES
INSUFFLATION TUBING1994-03-22
APPLIED MEDICAL RESOURCES
TROCAR STABILITY THREAD1993-12-23
APPLIED MEDICAL RESOURCES
TROCAR W/ BLUNT TIP OBTURATOR1993-11-05
APPLIED MEDICAL RESOURCES
DIAGNOSTIC INTRAVASCULAR CATHETER1993-09-24
APPLIED MEDICAL RESOURCES
SURGICAL TROCAR AND CANNULA1993-09-23
APPLIED MEDICAL RESOURCES
ENDOSCOPE ACCESSORY1993-09-07
APPLIED MEDICAL RESOURCES
UROLOGICAL CATHETER & ACCESSORIES1993-07-08
APPLIED MEDICAL RESOURCES
ACUCISE ELECTROSURGICAL TROCAR1993-06-17
APPLIED MEDICAL RESOURCES
FLEXIBLE URETERONEPHROSOCOPE1993-04-14
APPLIED MEDICAL RESOURCES
CHOLANGIOGRAPHY CLAMP1993-03-03
APPLIED MEDICAL RESOURCES
PRESSURE TURING AND ACCESSORIES1993-02-12
APPLIED MEDICAL RESOURCES
CHOLANGIOGRAPHY CATHETER1993-02-10
APPLIED MEDICAL RESOURCES
TRACHEOSTOMY TUBE AND TUBE CUFF1992-12-11

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Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020081810Bremerhaven,Federal Republic of Germany -> Long Beach, CaliforniaMACHINE3 PAL
202002252084Rotterdam,Netherlands -> Los Angeles, CaliforniaMEDICAL INSTRUMENTS15 PCS
2020020521375Rotterdam,Netherlands -> Los Angeles, CaliforniaMEDICAL INSTRUMENTS15 PCS
2020012540449Shanghai ,China (Mainland) -> Long Beach, CaliforniaCONNECTORS12 PKG
2020012550086Rotterdam,Netherlands -> Los Angeles, CaliforniaMEDICAL INSTRUMENTS15 PCS
2020011550140Rotterdam,Netherlands -> Los Angeles, CaliforniaMEDICAL INSTRUMENTS15 PCS
2020010934856Anvers,Belgium -> Savannah, GeorgiaARBURG INJECTION MOULDING MACHINE2 PCS
201910018991Stadersand,Federal Republic of Germany -> Los Angeles, CaliforniaMACHINES2 PKG

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