A.M.I. AGENCY FOR MEDICAL INNOVATIONS GMBH

FDA Device Registration & Listing · Feldkirch Vorarlberg, AT · Registration 3005049530

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3005049530
FEI Number
3005049530
Entity Name
A.M.I. AGENCY FOR MEDICAL INNOVATIONS GMBH
City/State/Country
Feldkirch Vorarlberg, AT
Establishment Address
IM LETTEN 1, Feldkirch Vorarlberg 6800, AT
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
AGENCY FOR MEDICAL INNOVATIONS GMBH (Owner Number: 9068871)
Owner / Operator Contact Address
IM LETTEN 1, --, FELDKIRCH, VORARLBERG, AT-NOTA A 6800, AT
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K243821
PMA Number
N/A

All Registered Proprietary Names

RAR Flexi Probes Wi-3 Fixation Nut Wi-3 Arm Wi-3 HAL-RAR Unit A.M.I. HAL Knotpusher / AHK 007 A.M.I. Knotpusher Premium / APK 001 FiXcision A.M.I. HAL-Doppler II System A.M.I. HAL-II Adaptor USA A.M.I. Recto Anal Repair Sleeve A.M.I. Recto Anal Repair Probe A.M.I. HAL Needleholder A.M.I. HAL Knotpusher A.M.I. HAL Handle A.M.I. HAL-II Electronic System RAR Flexi Probe RAR Precision Probe A.M.I. HAL / RAR System Comfort Drain Comfort Drain Grasper A.M.I. HAL Needleholder / AHN 006 i-Cut Power Supply Typ A i-Cut i-Cut Power Supply

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FHN Ligator, Hemorrhoidal Gastroenterology, Urology Class 2 876.4400 2015-06-16
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2015-06-16
HCF Instrument, Ligature Passing And Knot Tying General, Plastic Surgery Class 1 878.4800 2010-06-08
KOA Surgical Instruments, G-U, Manual (And Accessories) Gastroenterology, Urology Class 1 876.4730 2018-12-13
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2008-07-25
GBN Catheter, Pediatric, General & Plastic Surgery General, Plastic Surgery Class 1 878.4200 2013-12-27
GEJ Carrier, Ligature General, Plastic Surgery Class 1 878.4800 2010-06-08
HET Laparoscope, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.1720 2025-04-28

Official Correspondent

Tanja Kinzl

US Agent Details

Andrew Bendheim Business: Agency for Medical Innovations, Inc. Email: abendheim@amisurgical.com Phone: (781) 9901806

Related Public Records

Same Entity

AGENCY FOR MEDICAL INNOVATIONS GMBH
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K000397 Boston Scientific Corp SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228; INJECTION SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODEL 2000-03-07
K191007 Supersonic Imagine Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems 2019-10-25
K974588 Rimed , Ltd. INTRA-VIEW BILATERAL TRANSCRANIAL DOPPLER DEVICE, SMART-LITE PORTABLE BILATERAL TRANSCRANIAL DOPPLER DEVICE, COMPACT MOD 1998-08-07
K142628 Siemens Medi Cal Solutions, Inc. Acuson SC2000 Diagnostic Ultrasound System 2014-10-10
K132171 Supersonic Imagine AIXPLORER 2013-09-24

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0189-2022 FujiFilm Healthcare Americas Corporation 2
Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3
Z-0190-2022 FujiFilm Healthcare Americas Corporation 2
Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3
Z-0191-2022 FujiFilm Healthcare Americas Corporation 2
Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3
Z-0192-2022 FujiFilm Healthcare Americas Corporation 2
Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0
Z-1884-2024 FUJIFILM Healthcare Americas Corporation 2
Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24

Similar Registrations

Registration Number Establishment Name Location
3007648354 FETZER MEDICAL GMBH & CO.KG Tuttlingen Baden-Wurttemberg, DE
3016678045 Schneider ASR B.V. Rotterdam-Albrandswaard Zuid-Holland, NL
3011137372 Teleflex Medical LLC Morrisville, NC, US
3004001706 BR SURGICAL LLC Jacksonville, FL, US
1315756 Weco Manufacturing Group-Henrietta Rochester, NY, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005049530. Last updated year: 2026. Please use registration number 3005049530 when referencing this establishment in official correspondence.
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