Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3000286616

FEI Number

3000286616

Entity Name

DEWIMED MEDIZINTECHNIK GMBH

City/State/Country

TUTTLINGEN Baden-Wurttemberg, DE

Establishment Address

Unter Hasslen 14, TUTTLINGEN Baden-Wurttemberg D-78532, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

DEWIMED Medizintechnik GmbH (Owner Number: 9030270)

Owner / Operator Contact Address

Unter Hasslen 14, --, 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
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	1997-05-05
HAO	Instrument, Surgical, Non-Powered	Neurology	Class 1	882.4535	1997-05-06
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2014-10-29
FZS	Curette, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	1997-05-05
EMG	Forceps, Tooth Extractor, Surgical	Dental	Class 1	872.4565	2014-10-31
EMJ	Elevator, Surgical, Dental	Dental	Class 1	872.4565	2014-10-30
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2014-10-29
GAB	Needle, Suturing, Disposable	General, Plastic Surgery	Class 1	878.4800	2014-10-30
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	1997-05-05
HTC	Pliers, Surgical	General, Plastic Surgery	Class 1	878.4800	2014-10-31
HPB	Clip, Lens, Trial, Ophthalmic	Ophthalmic	Class 1	886.1410	2014-10-31
EMM	Chisel, Osteotome, Surgical	Dental	Class 1	872.4565	1997-05-05
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2014-10-30
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2024-07-10
EML	Chisel, Bone, Surgical	Dental	Class 1	872.4565	1997-05-05
EBR	Unit, Suction Operatory	Dental	Class 1	872.6640	2014-10-30
EMH	Forceps, Rongeur, Surgical	Dental	Class 1	872.4565	1997-05-05
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	1997-05-05
GAE	Snare, Surgical	General, Plastic Surgery	Class 1	878.4800	1997-05-05
GEG	Elevator, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1997-05-06
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	1997-05-06
HER	Pelvimeter, External	Obstetrics/Gynecology	Class 1	884.4520	2012-12-06
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	1997-05-05
GEO	File, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1997-05-06
EMK	Curette, Surgical, Dental	Dental	Class 1	872.4565	1997-05-05
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	1997-05-05
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1997-05-06
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2011-09-08
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	1997-05-05
EME	Punch, Biopsy, Surgical	Dental	Class 1	872.4565	1997-05-05
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	1997-05-06
MXY	Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal	Ophthalmic	Class 1	886.4350	2014-10-29
FTD	Lamp, Surgical	General, Plastic Surgery	Class 2	878.4580	2017-01-13
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	1997-05-06
GAF	Spatula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1997-05-05
DYJ	Retainer, Screw Expansion, Orthodontic	Dental	Class 1	872.5410	2012-01-17
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1997-05-06
EIX	Probe, Periodontic	Dental	Class 1	872.4565	2014-10-30
ECB	Unit, Syringe, Air And/Or Water	Dental	Class 1	872.4565	2014-10-30

Official Correspondent

No official correspondent registered.

US Agent Details

Franz Menean Business: MEDAGENT Inc. Email: mail@medagent-usa.com Phone: (603) 5702039

Related Public Records

Same Entity

DEWIMED Medizintechnik 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
K852723	The Huxley Instrument Corp.	FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420	1985-07-15
K873512	Arthropedics, Inc.	SERRATED GRASPING FORCEPS, RIGHT	1987-11-02
K081051	Spine View, Inc.	SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE	2008-08-07
K820777	The Anspach Effort, Inc.	MINI-MICRO ARTHROSCOPIC SCAPEL	1982-05-12
K922626	Andronic Devices, Ltd.	ADEPT INSTRUMENT POSITIONING ACCESSORY	1992-10-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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-0041-05	Linvatec Corp.	2	Ultra Power Burs, Sterile, Single-Use.
Z-0008-04	Rultract Inc	1	Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.
Z-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3000286616. Last updated year: 2026. Please use registration number 3000286616 when referencing this establishment in official correspondence.