REDA INSTRUMENTE GMBH

FDA Device Registration & Listing · TUTTLINGEN Baden-Wurttemberg, DE · Registration 8043496

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
8043496
FEI Number
3002807988
Entity Name
REDA INSTRUMENTE GMBH
City/State/Country
TUTTLINGEN Baden-Wurttemberg, DE
Establishment Address
GANSACKER 34, TUTTLINGEN Baden-Wurttemberg D-78532, DE
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
REDA INSTRUMENTE GMBH (Owner Number: 9001990)
Owner / Operator Contact Address
GANSACKER 34, --, TUTTLINGEN, DE-BW D-78532, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

MICHELE SPECULUM CRUTCHFIELD MARTIN KIRSCHNER HUDSON DENHARDT DRILL GUIDE ULRICH VAN BUREN STILLE-LISTON INGROWN NAIL INSTRUMENT FARABEUF LAMBOTTE ROCHESTER PEAN NAIL NIPPER FEILCHENFELD WILLIAMS ADSON ALLIS WILLAUER SPLINTER FORCEPS SEMKEN RADOLF RANKIN-KELLY RUSKIN-LISTON VERBRUEGGE CARMALT VIRTUS LANE SEMB LOWER BONE FILE SPATULA AND PACKER WIRE CUTTER REDA drill LAMBERT-LOWMAN CHISEL (OSTEOTOME) REINER scalpel handle no. 7K scalpel handle 3L, scalpel handle no. 4 L scalpel handle no. 4 scalpel handle no. 3 scalpel handle MINI scalpel handle no. 8, scalpel handle no. 7 NAIL NIPPER HOEN SINUSCOPY FORCEPS HARTMANN GRUBER HAMMER TAYLOR HAMMER BUCK Lateral Vaginal Retractor KEVORKIAN RECAIMER BUMM SIMS RANDALL BLAKE THOMAS GOURDET specimen-aspirating curette NOVAK MOD.MUENCHEN HEANY MICHELE DOUGLAS CARPENTER FISHER CANFIELD BRUENINGS ABRAHAM TEXTILE FILTER NEEDLE CASE Bone Hook FREER DENHARDT SIMON SCHROEDER LAMBERT-LOWMAN

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GEA Cannula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2026-03-26
LRW Scissors, General, Surgical General, Plastic Surgery Class 1 878.4800 2009-12-23
DWS Instruments, Surgical, Cardiovascular Cardiovascular Class 1 870.4500 2014-01-21
HRH Trephine, Manual, Ophthalmic Ophthalmic Class 1 886.4350 2013-02-28
KOH Instrument, Manual, General Obstetric-Gynecologic Obstetrics/Gynecology Class 1 884.4520 2024-04-07
EGN Scissors, Surgical Tissue, Dental Dental Class 1 872.4565 1991-01-04
EMF Knife, Surgical General, Plastic Surgery Class 1 878.4800 2013-02-28
KAG Holder, Speculum, Ent General, Plastic Surgery Class 1 878.1800 1998-08-20
HWW Countersink Orthopedic Class 1 888.4540 2013-02-06
HXK Holder, Needle; Orthopedic Orthopedic Class 1 888.4540 2013-02-28
FFO Retractor, Self-Retaining Gastroenterology, Urology Class 1 876.4730 2013-02-05
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2013-02-05
HTD Forceps General, Plastic Surgery Class 1 878.4800 2013-02-06
GAB Needle, Suturing, Disposable General, Plastic Surgery Class 1 878.4800 2024-04-07
FZT Cutter, Surgical General, Plastic Surgery Class 1 878.4800 2013-02-05
GEN Forceps, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1994-05-11
GEO File, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2009-12-23
FAX Bougie, Urological Gastroenterology, Urology Class 1 876.5520 1999-10-22
GAF Spatula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2013-02-28
HXG Tamp Orthopedic Class 1 888.4540 2013-02-06
HHM Sound, Uterine Obstetrics/Gynecology Class 1 884.4530 1995-07-21
HXZ Cutter, Wire Orthopedic Class 1 888.4540 2013-02-05
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2025-03-25
GFB Head, Surgical, Hammer General, Plastic Surgery Class 1 878.4820 2013-02-28
HTW Bit, Drill Orthopedic Class 1 888.4540 2013-02-28
GDJ Clamp, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2013-02-05
KDG Chisel (Osteotome) General, Plastic Surgery Class 1 878.4820 1995-07-21
GDN Knife, Amputation General, Plastic Surgery Class 1 878.4800 2013-02-05
HXY Brace, Drill Orthopedic Class 1 888.4540 2013-02-28
GDZ Handle, Scalpel General, Plastic Surgery Class 1 878.4800 1995-07-21
JYR Nipper, Malleus Ear, Nose, Throat Class 1 874.4420 2013-02-06
FXE Speculum, Non-Illuminated General, Plastic Surgery Class 1 878.1800 2013-02-28
KAE Forceps, Ent Ear, Nose, Throat Class 1 874.4420 1999-10-22
EPY Speculum, Ent General, Plastic Surgery Class 1 878.1800 2013-02-05
HXL Mallet General, Plastic Surgery Class 1 878.4800 1992-09-28
HTF Curette General, Plastic Surgery Class 1 878.4800 2013-02-06
EME Punch, Biopsy, Surgical Dental Class 1 872.4565 2004-09-15
HXS Twister, Wire Orthopedic Class 1 888.4540 2013-02-06
HDL Retractor, Vaginal Obstetrics/Gynecology Class 1 884.4520 2010-04-12
FZS Curette, Surgical, General Use General, Plastic Surgery Class 1 878.4800 1999-10-22
HXB Probe Orthopedic Class 1 888.4540 2009-12-23
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 1995-10-12
HWK Trephine Orthopedic Class 1 888.4540 2013-02-06
FHQ Holder, Needle, Gastroenterologic Gastroenterology, Urology Class 1 876.4730 1995-03-13
FTY Tape, Measuring, Rulers And Calipers General, Plastic Surgery Class 1 878.4800 2010-04-12
KBQ Knife, Tonsil Ear, Nose, Throat Class 1 874.4420 1999-10-22
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 1998-08-20
JOL Catheter And Tip, Suction General Hospital Class 2 880.6740 2026-03-18
EIG Retractor, All Types Dental Class 1 872.4565 1991-01-04
HNW Dilator, Lachrymal Ophthalmic Class 1 886.4350 1994-06-02
GDG Hook, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1994-06-02
HDF Speculum, Vaginal, Metal Obstetrics/Gynecology Class 1 884.4520 1991-01-15
KBN Gag, Mouth Ear, Nose, Throat Class 1 874.4420 2009-12-23
EMH Forceps, Rongeur, Surgical Dental Class 1 872.4565 1997-09-04
FHL Scoop Gastroenterology, Urology Class 1 876.4730 1998-08-20
GWY Pinwheel Neurology Class 1 882.1750 1995-07-21
FCL Forceps, Biopsy, Non-Electric Gastroenterology, Urology Class 1 876.1075 2019-07-03
HXD Clamp General, Plastic Surgery Class 1 878.4800 1992-09-28

Official Correspondent

No official correspondent registered.

US Agent Details

Angelika Scherp Business: Business Support International Email: info@bsi-fda.com Phone: (212) 3318358

Related Public Records

Same Entity

REDA INSTRUMENTE 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
K863293 Lifestream Int'L, Inc. DISPOSABLE SUCTION CANNULA NO. 902008-000 1986-09-09
K821275 Conphar, Inc. MAYO SCISSOR STRAIGHT 5 1/2 1982-05-28
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
K851170 The Huxley Instrument Corp. DISSECTING TWEEZER #283-72PCS. SS 410 1985-04-25

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0008-04 Rultract Inc 1
Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.
Z-0009-2007 Smith & Nephew Inc 1
Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007 Smith & Nephew Inc 1
Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06 Stryker Howmedica Osteonics Corp. 1
Allocraft TLIF Bone Inserter.
Z-0011-2007 Smith & Nephew Inc 1
Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8043496. Last updated year: 2026. Please use registration number 8043496 when referencing this establishment in official correspondence.
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