Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003322138

FEI Number

3003322138

Entity Name

Kreidler Medizintechnik GmbH

City/State/Country

Wurmlingen Baden-Wurttemberg, DE

Establishment Address

Faulenbachstr. 19, Wurmlingen Baden-Wurttemberg 78573, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

MEDICON, E.G. (Owner Number: 10052417)

Owner / Operator Contact Address

Gaensaecker 15, Tuttlingen, DE-BW 78532, DE

Initial Importer Flag

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
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2016-12-17
JEY	Plate, Bone	Dental	Class 2	872.4760	2016-12-17
HXW	Bender	Orthopedic	Class 1	888.4540	2016-12-17
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-12-14
HXZ	Cutter, Wire	Orthopedic	Class 1	888.4540	2016-12-17
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2021-04-16
HXY	Brace, Drill	Orthopedic	Class 1	888.4540	2016-12-17
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2026-02-04
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2026-02-04
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2016-12-17
HTX	Rongeur	Orthopedic	Class 1	888.4540	2016-12-17
FNS	Ring Cutter	General Hospital	Class 1	880.6200	2016-12-17
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2016-12-16
GEG	Elevator, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2026-02-04
GZT	Retractor, Self-Retaining, For Neurosurgery	Neurology	Class 2	882.4800	2020-11-16
KBN	Gag, Mouth	Ear, Nose, Throat	Class 1	874.4420	2016-12-17
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2016-12-17
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2016-12-17
EPY	Speculum, Ent	General, Plastic Surgery	Class 1	878.1800	2016-12-16
JYK	Holder, Ear Speculum	General, Plastic Surgery	Class 1	878.1800	2016-12-17
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	2016-12-17
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2016-12-16
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2016-12-17
JEY	Plate, Bone	Dental	Class 2	872.4760	2020-11-16
HWO	Skid, Bone	Orthopedic	Class 1	888.4540	2016-12-17
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2026-02-04
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2016-12-17
KBA	Rasp, Nasal	Ear, Nose, Throat	Class 1	874.4420	2016-12-17
HRR	Scissors, Orthopedic, Surgical	Orthopedic	Class 1	888.4540	2016-12-17
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2016-12-16
HFX	Clamp, Circumcision	Obstetrics/Gynecology	Class 2	884.4530	2016-12-17
GAC	Rasp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2026-02-04
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-09-22
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2016-07-26
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2016-12-17

Official Correspondent

Mario Waizenegger

US Agent Details

Angelika Scherp Business: BUSINESS SUPPORT INTERNATIONAL Email: info@bsi-fda.com Phone: (212) 3128358

Related Public Records

Same Entity

MEDICON, E.G.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3002862271	Wenzler Medizintechnik GmbH	Frittlingen Baden-Wurttemberg, DE
3022747125	Stehle Medizintechnik	Renquishausen Baden-Wurttemberg, DE
3013497507	Teufel & Gerlach GmbH	Tuttlingen Baden-Wurttemberg, DE
8010099	MEDICON, E.G.	TUTTLINGEN Baden-Wurttemberg, DE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K172572	Stryker	Stryker Upper-Face AXS screws and Mid-Face AXS screws	2017-10-31
K121589	Biomet Microfixation	BIOMET MICROFIXATION FACIAL PLATING SYSTEM	2012-09-21
K984230	Osteogenics Biomedical, Inc.	OSTEO-MESH TM-300	1999-02-04
K021618	Osteomed Corp.	OSA RIGID INTERNAL FIXATION SYSTEM	2002-08-08
K042598	Zimmer, Inc.	PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES	2004-10-29

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0043-2007	Bioplate Inc	2	Bioplate Resorbable Bone Fixation Tack, Catalog Number: 89-0120, Item Number: SG#-45
Z-0034-2022	Flower Orthopedics Corporation	2	Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Z-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
Z-0144-2024	Covidien	1	Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
Z-0168-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003322138. Last updated year: 2026. Please use registration number 3003322138 when referencing this establishment in official correspondence.