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:

• Applied Medical Europe

FDA Registration(s)

• Registration Number: 3009763019
• FEI Number: 3009763019
• Name: Applied Medical Europe
• Owner & Operator: APPLIED MEDICAL RESOURCES
• Contact Address: 22872 AVENIDA EMPRESA --; Rancho Santa Margarita CA 92688 US
• US Agent:
  • Nathalie Raad
  • Applied Medical Resources
  • 949 7138457
  • nraad@appliedmedical.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Wiekenweg 21 ; Amersfoort Utrecht, 3815 KL NL
• Establishment Type: Export Device to the United States But Perform No Other Operation on Device

• Registration Number: 3009051888
• FEI Number: 3009051888
• Name: Applied Medical Distribution Center
• Owner & Operator: APPLIED MEDICAL RESOURCES
• Contact Address: 22872 AVENIDA EMPRESA --; Rancho Santa Margarita CA 92688 US
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 9401 Toledo Way ; Irvine, CA 92618 US
• Establishment Type:
  • Manufacture Medical Device
  • Remanufacture Medical Device
  • Manufacture Device in the United States for Export Only

• Registration Number: 2027111
• FEI Number: 2027111
• Name: APPLIED MEDICAL RESOURCES CORP.
• Owner & Operator: APPLIED MEDICAL RESOURCES
• Contact Address: 22872 AVENIDA EMPRESA --; Rancho Santa Margarita CA 92688 US
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 22872 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	Device	Date
PMN K200021 Applied Medical Resources	Applied Medical Anoscope	2021-01-06
PMN K171701 | FER Applied Medical Europe [APPLIED MEDICAL RESOURCES]	GelPOINT Path Transanal Access Platform	2017-12-11
PMN K171701 | FER Applied Medical Distribution Center [APPLIED MEDICAL RESOURCES]	GelPOINT Path Transanal Access Platform	2017-12-11
PMN K171701 | FER APPLIED MEDICAL RESOURCES CORP. [APPLIED MEDICAL RESOURCES]	GelPOINT Path Transanal Access Platform	2017-12-11
PMN K162676 Applied Medical Resources	Voyant Open Fusion Device	2016-12-01
PMN K153017 APPLIED MEDICAL RESOURCES	Voyant Fine Fusion	2016-07-06
PMN K153288 APPLIED MEDICAL RESOURCES	Voyant Open Fusion Device	2016-06-01
PMN K151480 APPLIED MEDICAL RESOURCES	Epix Electrosurgical Probe With Smoke Evacuation	2016-02-19
PMN K143308 | HEW Applied Medical Europe [APPLIED MEDICAL RESOURCES]	GelPOINT Tansvaginal Access Platform	2015-12-22
PMN K143308 | HEW Applied Medical Distribution Center [APPLIED MEDICAL RESOURCES]	GelPOINT Tansvaginal Access Platform	2015-12-22
PMN K143308 | HEW APPLIED MEDICAL RESOURCES CORP. [APPLIED MEDICAL RESOURCES]	GelPOINT Tansvaginal Access Platform	2015-12-22
PMN K143308 APPLIED MEDICAL RESOURCES	GelPOINT Transvaginal Access Platform	2015-10-13
PMN K143536 APPLIED MEDICAL RESOURCES	Voyant Fine Fusion Device	2015-04-16
PMN K143517 APPLIED MEDICAL RESOURCES	Voyant Open Sealer-Divider Device	2015-03-27
PMN K142427 APPLIED MEDICAL RESOURCES	TISSUE CONTAINMENT SYSTEM; 10, 14, 17, 25	2014-12-23
PMN K141288 APPLIED MEDICAL RESOURCES	VOYANT ELECTROSURGICAL GENERATOR, VOYANT 5MM LAPAROSCOPIC SEALER-DIVIDER DEVICE	2014-08-22
PMN K100959 APPLIED MEDICAL RESOURCES	SPECIMEN RETRIEVAL SYSTEM	2010-04-22
PMN K062907 APPLIED MEDICAL RESOURCES	ALEXIS WOUND RETRACTOR	2007-01-09
PMN K032889 APPLIED MEDICAL RESOURCES	OPTICAL SEPARATOR	2003-10-02
PMN K000545 APPLIED MEDICAL RESOURCES	SENTRY EXPANDING INTRODUCER SHEATH (EIS)	2000-05-02
PMN K993650 APPLIED MEDICAL RESOURCES	URETERAL ACCESS SHEATH SET - NEW MODELS	1999-12-28
PMN K993135 APPLIED MEDICAL RESOURCES	IMPLANTABLE CLIP FOR GENERAL SURGERY	1999-12-01
PMN K992852 APPLIED MEDICAL RESOURCES	SUTURE CLINCH	1999-11-22
PMN K991219 APPLIED MEDICAL RESOURCES	C-FLEX URETERAL STENTS	1999-06-21
PMN K983154 APPLIED MEDICAL RESOURCES	CYSTIC DUCT BALLOON DILATING CATHETER	1999-05-05
PMN K990775 APPLIED MEDICAL RESOURCES	URETERAL ACCESS SHEATH SET	1999-04-21
PMN K983744 APPLIED MEDICAL RESOURCES	MCAS (MODULAR CLIP APPLIER SYSTEM)	1999-01-21
PMN K973465 APPLIED MEDICAL RESOURCES	LATIS GRAFT CLEANING CATHETER	1998-02-19
PMN K973891 APPLIED MEDICAL RESOURCES	LAPAROSCOPIC GASTROSTOMY KIT	1998-01-12
PMN K962777 APPLIED MEDICAL RESOURCES	AMR MINI-LAPAROSCOPE	1997-08-06
PMN K971498 APPLIED MEDICAL RESOURCES	APPLIED MEDICAL LAPAROSCOPIC GUIDEWIRE	1997-05-05
PMN K963886 APPLIED MEDICAL RESOURCES	EVS	1997-04-24
PMN K970762 APPLIED MEDICAL RESOURCES	DUAL LUMEN EMBOLECTOMY CATHETER	1997-03-28
PMN K964470 APPLIED MEDICAL RESOURCES	APPLIED MEDICAL CLIP APPLIER	1997-01-22
PMN K962668 APPLIED MEDICAL RESOURCES	AMR-ACV CLAMPS	1996-11-04
PMN K963359 APPLIED MEDICAL RESOURCES	INSUFFLATION NEEDLE	1996-09-24
PMN K962395 APPLIED MEDICAL RESOURCES	SPECIMEN RETRIEVAL BAG	1996-07-05
PMN K951721 APPLIED MEDICAL RESOURCES	APPLIED MEDICAL 1.5MM REUSABLE ANGIOSCOPE	1995-07-11
PMN K950702 APPLIED MEDICAL RESOURCES	LAPAROSCOPIC CLAMP	1995-05-25
PMN K950586 APPLIED MEDICAL RESOURCES	AVD INTIMAX THROMBECTOMY CATHETER	1995-05-15
PMN K950492 APPLIED MEDICAL RESOURCES	ATRAUMAX SURGICAL CLAMP	1995-05-08
PMN K945741 APPLIED MEDICAL RESOURCES	TROCAR AND CANNULA ACCESSORY	1995-02-28
PMN K945591 APPLIED MEDICAL RESOURCES	APPLIED MEDICAL OPTICAL VALVULOTOME	1995-02-10
PMN K950267 APPLIED MEDICAL RESOURCES	URETHRAL SUTURE GUIDE	1995-01-31
PMN K944790 APPLIED MEDICAL RESOURCES	FLEXIBLE LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER	1994-11-29
PMN K944135 APPLIED MEDICAL RESOURCES	UROLOGICAL GUIDWIRE	1994-09-21
PMN K943489 APPLIED MEDICAL RESOURCES	DISPOSABLE SURGICAL TROCAR	1994-08-09
PMN K941011 APPLIED MEDICAL RESOURCES	ACU-SIZER(TM)	1994-06-13
PMN K941012 APPLIED MEDICAL RESOURCES	LOW PRESSURE TAMPONADE BALLOON CATHETER	1994-04-18
PMN K941010 APPLIED MEDICAL RESOURCES	ACUCISE GUIDEWIRE EXCHANGE SHEATH	1994-04-18
PMN K933498 APPLIED MEDICAL RESOURCES	EXTERNAL VEIN STRIPPER	1994-03-23
PMN K924481 APPLIED MEDICAL RESOURCES	INSUFFLATION TUBING	1994-03-22
PMN K923568 APPLIED MEDICAL RESOURCES	TROCAR STABILITY THREAD	1993-12-23
PMN K923636 APPLIED MEDICAL RESOURCES	TROCAR W/ BLUNT TIP OBTURATOR	1993-11-05
PMN K930758 APPLIED MEDICAL RESOURCES	DIAGNOSTIC INTRAVASCULAR CATHETER	1993-09-24
PMN K932995 APPLIED MEDICAL RESOURCES	SURGICAL TROCAR AND CANNULA	1993-09-23
PMN K931895 APPLIED MEDICAL RESOURCES	ENDOSCOPE ACCESSORY	1993-09-07
PMN K930882 APPLIED MEDICAL RESOURCES	UROLOGICAL CATHETER & ACCESSORIES	1993-07-08
PMN K925984 APPLIED MEDICAL RESOURCES	ACUCISE ELECTROSURGICAL TROCAR	1993-06-17
PMN K924135 APPLIED MEDICAL RESOURCES	FLEXIBLE URETERONEPHROSOCOPE	1993-04-14
PMN K924480 APPLIED MEDICAL RESOURCES	CHOLANGIOGRAPHY CLAMP	1993-03-03
PMN K925918 APPLIED MEDICAL RESOURCES	PRESSURE TURING AND ACCESSORIES	1993-02-12

Similar & Related FDA Registered Companies

• Applied Medical Resources Corporation

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020081810	Bremerhaven,Federal Republic of Germany -> Long Beach, California	MACHINE	3 PAL
202002252084	Rotterdam,Netherlands -> Los Angeles, California	MEDICAL INSTRUMENTS	15 PCS
2020020521375	Rotterdam,Netherlands -> Los Angeles, California	MEDICAL INSTRUMENTS	15 PCS
2020012540449	Shanghai ,China (Mainland) -> Long Beach, California	CONNECTORS	12 PKG
2020012550086	Rotterdam,Netherlands -> Los Angeles, California	MEDICAL INSTRUMENTS	15 PCS
2020011550140	Rotterdam,Netherlands -> Los Angeles, California	MEDICAL INSTRUMENTS	15 PCS
2020010934856	Anvers,Belgium -> Savannah, Georgia	ARBURG INJECTION MOULDING MACHINE	2 PCS
201910018991	Stadersand,Federal Republic of Germany -> Los Angeles, California	MACHINES	2 PKG