PSM Medical GmbH

FDA Device Registration & Listing · Gunningen Baden-Wurttemberg, DE · Registration 3008323540

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
3008323540
FEI Number
3008323540
Entity Name
PSM Medical GmbH
City/State/Country
Gunningen Baden-Wurttemberg, DE
Establishment Address
Gewerbestr. 10, Gunningen Baden-Wurttemberg 78594, DE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
PSM Medical GmbH (Owner Number: 10034286)
Owner / Operator Contact Address
Gewerbestr. 10, Gunningen, DE-BW 78594, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EJB Handle, Instrument, Dental Dental Class 1 872.4565 2010-11-19
ECO Spring, Orthodontic Dental Class 1 872.5410 2019-07-24
HTW Bit, Drill Orthopedic Class 1 888.4540 2010-11-19
HXX Screwdriver Orthopedic Class 1 888.4540 2010-11-19
DYJ Retainer, Screw Expansion, Orthodontic Dental Class 1 872.5410 2019-07-24
LRP Tray, Surgical General, Plastic Surgery Class 1 878.4800 2010-11-19
OAT Implant, Endosseous, Orthodontic Dental Class 2 872.3640 2011-12-21
DZD Tube, Orthodontic Dental Class 1 872.5410 2019-07-24
EJL Bur, Dental Dental Class 1 872.3240 2010-11-19

Official Correspondent

Marcel Schmid

US Agent Details

Terry Pracht Business: PSM North America, Inc Email: service@psm-na.us Phone: (800) 7331622

Related Public Records

Same Entity

PSM Medical 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
K881095 CooperVision, Inc. KOI(TM) INSTRUMENT TRAYS 1988-04-06
K110392 Psm Medical Solutions PSM LOMAS / BENEFIT SCREWS 2011-12-14

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0036-2010 Alphatec Spine, Inc. 1
ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.

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3012421607 MAINLINE MEDICAL DENTAL SUPPLY North York Ontario, CA
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008323540. Last updated year: 2026. Please use registration number 3008323540 when referencing this establishment in official correspondence.
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