Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8010298

FEI Number

3003448211

Entity Name

RUDOLF MEDICAL GMBH + CO. KG

City/State/Country

FRIDINGEN Baden-Wurttemberg, DE

Establishment Address

ZOLLERSTRASSE 1, FRIDINGEN Baden-Wurttemberg 78567, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

RUDOLF MEDICAL GMBH + CO. KG (Owner Number: 8010298)

Owner / Operator Contact Address

ZOLLERSTRASSE 1, --, FRIDINGEN, DE-BW 78567, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

JOSEF SCISSORS CLIP DISSECTING SCISSORS FENESTROMETER, Rosen myringotomy Scissors Esmarch

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	1997-08-11
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	1998-12-09
FZS	Curette, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	1998-12-09
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2009-07-24
GDO	Applier, Surgical, Clip	General, Plastic Surgery	Class 1	878.4800	2009-08-25
EFL	Forceps, Dressing, Dental	Dental	Class 1	872.4565	1977-12-30
KAM	Cannula, Sinus	General, Plastic Surgery	Class 1	878.4800	2003-08-01
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2009-08-28
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	1986-05-15
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	1998-12-09
KAD	Elevator, Ent	Ear, Nose, Throat	Class 1	874.4420	2003-07-25
FBM	Cannula And Trocar, Suprapubic, Non-Disposable	Gastroenterology, Urology	Class 1	876.5090	2009-08-17
KOH	Instrument, Manual, General Obstetric-Gynecologic	Obstetrics/Gynecology	Class 1	884.4520	2004-06-25
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	2009-08-20
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2009-08-17
HCZ	Forceps, Surgical, Gynecological	Obstetrics/Gynecology	Class 2	884.4530	2014-03-04
GAF	Spatula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1998-12-09
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	1998-12-09
KBD	Scissors, Nasal	Ear, Nose, Throat	Class 1	874.4420	1977-12-30
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2009-07-23
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2004-05-04
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2009-08-28
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2009-08-28
HWJ	Awl	Orthopedic	Class 1	888.4540	2009-08-20
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	1977-12-30
FFO	Retractor, Self-Retaining	Gastroenterology, Urology	Class 1	876.4730	1986-05-15
HCH	Clip, Aneurysm	Neurology	Class 2	882.5200	2009-09-07
HCI	Applier, Aneurysm Clip	Neurology	Class 2	882.4175	2009-09-07
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2009-07-23
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2008-10-06
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2009-07-24
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2009-07-24
JYO	Knife, Ear	Ear, Nose, Throat	Class 1	874.4420	2009-08-20
HRR	Scissors, Orthopedic, Surgical	Orthopedic	Class 1	888.4540	1997-08-11
KCA	Tonsillectome	Ear, Nose, Throat	Class 1	874.4420	2009-11-13
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1986-05-15
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2009-08-28
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	1998-12-09
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2009-07-21
KTG	Knife, Ent	Ear, Nose, Throat	Class 1	874.4420	2004-01-06
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2011-07-06
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	1977-12-30
HXK	Holder, Needle; Orthopedic	Orthopedic	Class 1	888.4540	1998-12-09
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2004-06-01
EBA	Light, Surgical Headlight	Dental	Class 1	872.4630	2004-06-01
HRH	Trephine, Manual, Ophthalmic	Ophthalmic	Class 1	886.4350	2009-05-06
FAX	Bougie, Urological	Gastroenterology, Urology	Class 1	876.5520	2005-02-24
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2009-08-19
FFQ	Speculum, Rectal	Gastroenterology, Urology	Class 1	876.4730	2009-08-19
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2009-05-05
KCG	Dilator, Tracheal	Ear, Nose, Throat	Class 1	874.4420	2006-08-24
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	1986-05-15
KBN	Gag, Mouth	Ear, Nose, Throat	Class 1	874.4420	1986-05-15
HXB	Probe	Orthopedic	Class 1	888.4540	1998-12-09
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	1998-12-09
GDL	Needle, Suturing, Reusable	General, Plastic Surgery	Class 1	878.4800	1998-12-09
HMQ	Marker, Sclera	Ophthalmic	Class 1	886.4570	2009-09-01
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1977-12-30
GFF	Bur, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4820	2009-09-03
HDF	Speculum, Vaginal, Metal	Obstetrics/Gynecology	Class 1	884.4520	1986-05-15
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2004-06-01
GDN	Knife, Amputation	General, Plastic Surgery	Class 1	878.4800	2009-06-08
GFJ	Mallet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1986-05-15
JYJ	Gauge, Measuring	Ear, Nose, Throat	Class 1	874.4420	2010-03-23
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	1998-12-09
HTZ	Instrument, Cutting, Orthopedic	General, Plastic Surgery	Class 1	878.4800	1986-05-15
KAI	Mirror, Ent	Ear, Nose, Throat	Class 1	874.4420	2003-09-16
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	1998-12-09
EPY	Speculum, Ent	General, Plastic Surgery	Class 1	878.1800	1986-05-15
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	2004-07-07
FZQ	Clip, Removable (Skin)	General, Plastic Surgery	Class 1	878.4320	2009-08-19

Official Correspondent

Ayfer Bektas

US Agent Details

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

Related Public Records

Same Entity

RUDOLF MEDICAL GMBH + CO. KG

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
K922626	Andronic Devices, Ltd.	ADEPT INSTRUMENT POSITIONING ACCESSORY	1992-10-19
K820290	The Anspach Effort, Inc.	SELF RETAINING RETRACTOR FOR HAND SURG	1982-03-05
K760422	Cutter Laboratories, Inc.	SURGICAL RETRACTOR	1976-08-23
K914997	Conmedcorp	ASP-IRRATOR	1992-01-07
K153773	Olympus Medical Systems Corp.	Disposal Lens Cleaning Sheath	2016-11-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
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-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.

Similar Registrations

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010298. Last updated year: 2026. Please use registration number 8010298 when referencing this establishment in official correspondence.