SFM Medical Devices GmbH

FDA Device Registration & Listing · Waechtersbach Hesse, DE · Registration 1000632857

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
1000632857
FEI Number
1000632857
Entity Name
SFM Medical Devices GmbH
City/State/Country
Waechtersbach Hesse, DE
Establishment Address
Brueckenstrasse 5, Waechtersbach Hesse 63607, DE
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
sfm medical devices GmbH (Owner Number: 9088579)
Owner / Operator Contact Address
Brueckenstrasse 5, --, Waechtersbach, DE-NOTA 63607, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

AccessKit, 10G, Single Pack, Bevel, Side Opening, sterile AccessKit, 10G, Single Pack, Diamond, Side Opening, sterile AccessKit, 10G, Single Pack, Diamond, End Opening, sterile AccessKit, 10G, Single Pack, Bevel, End Opening, sterile Implanter cannula Cannula for subcutaneous implant/pellet administration nexoderm® Dermal Curette Biopsy Kit, 10G, sterile nextaro® va, 15mm, 5µm (REF number: 20037) nextaro® va 13, 5µm Filter (REF number 20042) Access Drill, 10G, sterile PROBE, RADIOFREQUENCY LESION

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2019-04-29
GEA Cannula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2017-05-22
FZS Curette, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2026-06-17
MJG Device, Percutaneous, Biopsy General, Plastic Surgery Class 1 878.4800 2007-07-23
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2024-09-09
CAZ Anesthesia Conduction Kit Anesthesiology Class 2 868.5140 2017-06-22
HTW Bit, Drill Orthopedic Class 1 888.4540 2017-05-22
GXD Generator, Lesion, Radiofrequency Neurology Class 2 882.4400 2024-12-30
GXI Probe, Radiofrequency Lesion Neurology Class 2 882.4725 2024-12-30
CAZ Anesthesia Conduction Kit Anesthesiology Class 2 868.5140 2014-02-06
GXI Probe, Radiofrequency Lesion Neurology Class 2 882.4725 2020-07-13
GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery Class 1 878.4800 2006-06-16
CAZ Anesthesia Conduction Kit Anesthesiology Class 2 868.5140 2009-08-11
GXZ Electrode, Needle Neurology Class 2 882.1350 2009-08-11

Official Correspondent

No official correspondent registered.

US Agent Details

Ryan O'Callaghan Business: Phil Triolo and Associates LC Email: ryano@philt.com Phone: (801) 5732651

Related Public Records

Same Entity

sfm medical devices GmbH
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3007221462 safemed medical devices s.r.o. Prague Praha, Hlavni Mesto, CZ

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K243985 Icu Medical, Inc. Rio™ Drug Reconstitution Transfer Device 2025-01-22
K222718 Hangzhou Qiantang Longyue Biotechnology Co., Ltd. Vial Adapter 2023-03-10
K863293 Lifestream Int'L, Inc. DISPOSABLE SUCTION CANNULA NO. 902008-000 1986-09-09
K020354 Baylis Medical Co., Inc. BAYLIS PAIN MANAGEMENT GENERATOR (PMG), MODELS PMG-115 (DOMESTIC), PMG-230 (INTERNATIONAL) 2002-05-03
K201610 ABBOTT MEDICAL IonicRF Generator 2020-10-21

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0007-2017 Baxter Corporation Englewood 2
0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions. It attaches to a standard Baxter Pharmacy Pump Tube Set.
Z-0034-2012 X Spine Systems Inc 1
Axle Interspinous Fusion System Torque Driver Handle, Model #: X060-0323, Lot # 525941, S/Ns 001-017, Lot # 525942, S/Ns 001-050, Mfr. By: Bradshaw Medical Inc., Kenosha, WI 53144 The Axle Torque Driver Handle is used to lock the set screw into the locking plate.
Z-0025-2011 Medical Device Technologies, Inc. 1
Tru-Core II Disposable Automatic Biopsy Instrument and Tru-Core II URO Disposable Automatic Biopsy Instrument. The Tru-Core Disposable Automatic Biopsy Instrument is used to obtain multiple core samples from soft tissue such as liver, kidney, prostate, breast, ect. The recalling lot's for the product are as follows: Model Number: 763114100X Lot #'s: 92661WY5, 93211XXV, 00141YVE, 00541ZKX, 010920HL, 01522192, 92791X5I, 93271Y1W, 00201YYE, 00621ZQ3, 011320LH, 015221BD, 92791X7X, 93411Y9O, 00211Z0C, 00671ZRN, 011720Q, 015521CL, 92861XCT, 93421YBJ, 00251Z1T, 00761ZZP, 012420U0, 016221H2, 93001XLG, 93431YBI, 00351Z86, 0081201Y, 0138211F, 016721KJ, 93081XPC, 93571YJO, 00461ZE2, 0088206B, 0141215R, 93141XST, 00061YOV, 00541ZK0, 009620BO, 0146219M. Model Number: 763114160X Lot #'s 92661WY7, 00111YPZ, 00671ZRO, 013220Z7, 016221H7, 93131XLS, 00331Z61, 0110201Y, 014125Q, 00882065, 00391Z8Y, 013120YC, 015521CJ. Model Number: 763114200X Lot #'s 92661WY0, 00751ZYJ, 012420U1 Model Number: 763116100X Lot #'s 92791X80, 93491YG9, 00331Z6M, 0083203O, 012420U3, 01672KL, 92791X81, 93501YGA, 00351Z8D, 009620BL, 013120Y9, 92931XDD, 00121YRT, 00431ZE1, 009920D3, 015221AX, 93001XLN, 00131YUG, 00541ZKV, 011020IU, 015221BE, 93081XPH, 00541ZJY, 00601ZOT, 011320LG, 015521CK, 93291Y43, 00251Z1R, 0081201W, 012020QC, 016221H3. Model Number: 763116160X Lot #'s 92661WY3, 00882068, 00351Z8A, 00761ZZQ, 012020QB, 016721KK, 92791X89, 00912084, 00471ZG0, 010320FM, 012420TZ, 92861XD4, 01472193, 00541ZK1, 010920HK, 0141215U, 93001XLR, 00151YVC, 00601ZOR, 0110201V, 015521CM, 93291Y40, 00331Z6J, 00701ZUX, 011720OP, 016221HS Model Number: 763116200X Lot #'s 121KN Model Number: 763116200X Lot #'s 92671X09, 00471ZG1, 00882067, 010320FN, 00211Z09, 00601ZOP, 009920D0, 011020IT Model Number: 763118100X Lot #'s 92661WY8, 93491YG7, 00331Z6L, 00621ZQ2, 009920D2, 0138213F, 92791X7Z, 93491YG8, 00351Z88, 00701ZUW, 010320FL, 01472194, 92861XDS, 00061YOT, 00471ZG2, 00761ZZO, 0110201W, 016221H4, 93091XPL, 00131YUF, 00541ZJZ, 0083203P, 012020QE, 93211XXW, 00251Z1S, 00541ZKU, 009620BM, 012420TX. Model Number: 763118160X Lot #s 92661WY6, 93271Y1V, 00201YYD, 00471ZG3, 012420U2, 016221GZ, 92671WZJ, 93411Y9P, 00251Z1Q, 00671ZRK, 013120YB, 92671WZK, 93421YBK, 00331Z6N, 00701ZUY, 013220Z9, 92861XD0, 00061YOW, 00351Z8E, 00882069, 015221BB, 93001XLM, 00111YQO, 00431ZE3, 009920D4, 015521CO. Model Number: 763118200X Lot #s 92861XCD, 93571YJN, 00331Z6K, 00671ZRM, 011320LF, 01382134, 93001XL6, 0061YOU, 00351Z89,00701ZUZ, 011720OO, 0141215S, 93001XLJ, 00912082, 00391Z8Z, 009620BQ, 012020QA, 01472195, 93081XPJ, 00111YQM, 00471ZG5, 009920D5, 013120Y8, 016221H1, 93211XXX, 00131YUD, 00481ZG4, 010320FJ, 013220Z6, 93400Y9K, 00201YYC, 00621ZQ1, 010920HJ, 0137211I. Model Number: 763120100X Lot #s 93001XLV, 00351Z8B, 0088206A, 01472196, 00331Z60, 00601ZOS, 01202QF. Model Number: 763120160X Lot #s 92661WY1, 00882066, 00111YQP, 00351Z8C, 013120YD, 01472197, 92861XDG, 00912083, 00211Z08, 00621ZQ5, 013220Z8. Model Number: 763120200X Lot #s 00351Z85, 012020QG, 012420TW. Model Number: 763418200X Lot #s 92671WZV, 93291Y41, 00351Z87, 00601ZNH, 010320FK, 0141215T, 92671WZW, 00061YOX, 00431ZE0, 0083203N, 0110201S, 015221BC, 92861XDH, 00131YUE, 00491ZIO, 009620BN, 0011720ON, 015521CN, 93081XPR, 00141YVB, 00541ZKT, 009920D1, 0138213E, 016221H6. Model Number: 763418250X Lot #s 92751X60, 00671ZRL, Model Number: 763418250X Lot #s 92661WY4, 93271Y1N, 00141YVD, 00601ZOQ, 0110201X, 013220ZA, 92751X6P, 93291Y42, 00211Z0B, 00761ZZR, 012020QD, 0137211G, 92781X5G, 93631YJP, 00221Z13, 0081201X, 012420TY, 01382133, 92861XDN, 00912085, 00431ZDZ, 009620BP, 013120YA, 016221H0.
Z-0664-2020 Abbott Medical 2
Radiofrequency Grounding Pad, REF RF-DGP-L
Z-0720-2020 Abbott Medical 2
CLASSIC Radiofrequency Cannula - Curved, 10 cm, SMK Compatible Electrode, REF C-1005-S - Product Usage: Disposable Radiofrequency Cannulae are provided in either straight, curved, or curved blunt geometries with a stylet inserted in the cannula. Cannulae are insulated except for the active tip. The active tip determines the size of the radiofrequency lesion.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000632857. Last updated year: 2026. Please use registration number 1000632857 when referencing this establishment in official correspondence.
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