Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006554912

FEI Number

3006554912

Entity Name

STERIS Deutschland GmBh

City/State/Country

Wurmlingen Baden-Wurttemberg, DE

Establishment Address

KANTSTRASSE 33/1, Wurmlingen Baden-Wurttemberg D-78573, DE

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Repack or Relabel Medical Device

Owner / Operator

STERIS (Owner Number: 10091086)

Owner / Operator Contact Address

5960 Heisley Rd, Mentor, OH 44060, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Ergonomic Take Apart (ST-MF, RR, WM-FE,RR) Snowden-Pencer (ST-MF,RR, WM-FE,RR) V. Mueller Urethral Dilator (ST-SD, WM-FE,RR) V. Mueller Ear Syringe (WM-FE,RR) V. Mueller Skin Hook (ST-MF, WM-FE,RR) Snowden-Pencer Skin Hook (ST-MF, WM-FE,RR) V. Mueller Ophthalmic Caliper (ST-CFE,SD, WM-FE,RR) V. Mueller Peripheral and Aortic Clamps (WM-FE,RR) V. Mueller Tongue Depressor (ST-MF, WM-FE,RR) V. Mueller Tonsil Knife (ST-SD, WM-FE,RR) V. Mueller Currettte (ST-CFE,SD, WM-FE,RR) Snowden-Pencer Dental Currette (ST-SD, WM-FE, RR) Snowden-Pencer Rongeur (ST-CFE, WM-FE,RR) V. Mueller Rongeur (ST-CFE,SD, WM-FE,RR) V. Mueller Ear Suction Tube (ST-MF, WM-FE,RR) V. Mueller Ophthalmic Retractor (ST-MF-WM-FE,RR) V. Mueller ENT Retractor (ST-MF, WM-FE,RR) V. Mueller Gastrological Probe (ST-MF, WM-FE,RR) V. Mueller Nasal Rongeur (ST-CFE, WM-FE,RR) V. Mueller Manual Clamp (ST-SD, WM-FE, RR) V. Mueller Elevator (WM-FE,RR) Snowden-Pencer Elevator (ST-MF, WM-FE,RR) V. Mueller Fixation Ring (ST-SD, WM-FE,RR) V. Mueller Elevator (ST-MF, WM-FE,RR) V. Mueller Rongeur (WM-FE,RR) V. Mueller Bone Hooks (ST-MF, WM-FE,RR) V. Mueller Retractor (ST-MF.RR, WM-FE,RR) Snowden Pencer Retractor (ST-MF.RR, WM-FE,RR) V. Mueller Forceps (WM-FE,RR) Snowden-Pencer Forceps (ST-MF, WM-FE,RR) Snowden Pencer Hemostat (ST-CFE, WM-FE,RR) V. Mueller Affinity Hemostat (ST-CFE, WM-FE,RR) V. Mueller Hand Drill (WM-FE,RR) V. Mueller Eye Needle Holder (ST-SD, WM-FE,RR) V. Mueller Bulldog Clamp (WM-FE,RR) V. Mueller Orthopedic Shears (ST-CFE, WM-CFE,RR) V. Mueller Ossicle Holding Forceps (WM-FE,RR) V. Mueller Miscellaneous Cutting and Coagulator Accessories (WM-FE,RR) Snowden-Pencer Saw Loop (ST-CFE, WM-FE, RR) V. Mueller Saw Blades (ST-CFE, WM-FE,RR) V. Mueller Hirschman Anoscope (ST-SD, WM-FE, RR) V. Mueller Obstetrical Forceps (ST-SD, WM-FE,RR) V. Mueller Ophthalmic Spoon Currette (ST-SD, WM-FE,RR) V. Mueller Nasal Knife (ST-MF, WM-FE,RR) V. Mueller Perforator (ST-MF, WM-FE,RR) V. Mueller Tissue Forceps (WM-FE,RR) V. Mueller Tenaculum Hook (ST-SD.WM-FE, RR) V. Mueller Ear Hook (ST-MF, WM-FE,RR) V. Mueller Neuro/Spine VERSA-TRAC (ST-RR, WM-FE) V. Mueller Neuro/Spine Shadow-Line (ST-RR, WM-FE,RR) V. Mueller Retraction and Distraction Platforms (ST-MF,RR, WM-FE,RR) V. Mueller Gigle Wire Saw and Blades (WM-FE,RR) V. Mueller Surgical Clamp (WM-FE,RR) V. Mueller Gynecological Forceps (ST-SD,CFE, WM-FE,RR) V. Mueller Pinwheel (WM-FE,RR) V. Mueller Urethrotome (ST-SD, WM-FE,RR) V. Mueller Vaginal Specula (ST-SD, WM-FE,RR) V. Mueller Cardiovascular Surgical Instrument (ST-MF,RR , WM-FE,RR) Snowden-Pencer Cardiovascular Surgical Instrument (ST-MF,RR, WM-FE,RR) V. Mueller Affinity Tenaculum Forceps (ST-SD, WM-FE,RR) V. Mueller Rectal Probe or Hook (WM-FE,RR) V. Mueller Nasal Rasp (ST-MF, WM-FE,RR) Snowden-Pencer MicroLap 3mm Laparoscopic Instruments (WM-FE,RR) V. Mueller ENT Elevator (ST-MF, WM-FE,RR) V. Mueller Tracheal Dilator (ST-SD, WM-FE,RR) V. Mueller Lead Hand Malleable (ST-SD, WM-FE,RR) V. Mueller Ear Snare (ST-CFE, WM-FE,RR) V. Mueller Vascular Clamps (ST-CFE, WM-FE, RR) V, Mueller Vascular Forceps (ST-SD,CFE) V. Mueller Affinity Clamps (ST-SD) V. Mueller Percussor (WM-FE,RR) V. Mueller Biopsy Punch (WM-FE,RR) V. Mueller Vasectomy Forceps (WM-FE,RR) V. Mueller Episiotomy Scissors (SD-CFE, WM-FE,RR) V. Mueller Vascular Clamps (ST-CFE, WM-FE,RR) V. Mueller Cushing Elevator (WM-FE,RR) V. Mueller Ligature Carriers & Needles (ST-MF, WM-FE,RR) V. Mueller Nail Nippers (ST-RR,WM-FE,RR) (OS3063, SA15100, SA15110, SA15120, SA15132) V, Mueller Nail Nippers (WM-FE, RR) (SU15085, SU15100, SU15110, SU15120, SU15130, SU15131) V. Mueller Patterson Trocar (WM-FE,RR) Snowden-Pencer MIS Instruments (ST-RR, WM-FE,RR) V. Mueller MIS Instruments (ST-RR, WM-FE,RR) Snowden-Pencer Endoplastic (WM-FE,RR) V. Mueller Drill and Saw (ST-SD, WM-FE, RR) V. Mueller Mouth Gag (ST-SD, WM-FE,RR) V. Mueller Neuro/Spine Retractors (ST-MF,RR) V. Mueller Retractor Blade (ST-MF,RR) V. Mueller Retractors (WM-FE,RR) V. Mueller Laryngeal Knife Handle (WM-FE,RR) V. MUELLER ENT Forceps (WM-FE,RR) Snowden-Pencer ENT Forceps (WM-FE,RR) V. Mueller Vein Stripper (WM-FE,RR) Snowden-Pencer Needle Holder (ST-SD, WM-FE,RR) V, Mueller Needle Holder (ST-SD, WM-FE,RR) V. Mueller Uterine Elevator (WM-FE,RR) V. Mueller Uterine Sound (ST-MF, WM-FE,RR) V. Mueller Ophthalmic Hook (ST-MF, WM-FE,RR) V. Mueller Adenoid Punch (WM-FE,RR) V. Mueller Malleus Nipper (ST-CFE,SD, WM-FE,RR) V. Mueller Retractor (ST-MF, WM-FE,RR) V. Mueller Caliper (ST-MF, WM-FE,RR) V. Mueller Cast Spreader and Remover (ST-RR, WM-FE,RR) V. Mueller Suction Tube (ST-MF, WM-FE,RR) V. Mueller Ear Knife (ST-MF, WM-FE,RR) V. Mueller Bone File Bayonet (WM-RR) V. Mueller Bone File (ST-CFE) V. Mueller Stripper (ST-SD, WM-FE, RR) V. Mueller Penile Clamp (ST-MF, WM-FE,RR) V. Mueller Uterine Clamps and Forceps (WM-FE,RR) Snowden-Pencer Retractor & Dissector (ST-RR, WM-FE) V. Mueller Retractor & Dissector (ST-RR, WM-FE, RR) V. Mueller Boipolar Forceps (WM-FE,RR) V. Mueller Dialator Probe (ST-SD, WM-FE,RR) V. Mueller Micro Scissors (ST-MF, WM-FE,RR) V. Mueller Lefort Urethral (ST-MF) V. Mueller Jewett Urethral (ST-MF) V. Mueller Van Buren Urethral (ST-MF) V. Mueller McCrea Female Sound (ST-MF) V. Mueller Campbell Miniature (ST-SD, WM-RR,FE) V. Mueller Otis Urethral (ST-SD, WM-RR, FE) V. Mueller Nasal Scissiors (ST-SD, WM-FE,RR) V. Mueller Uterine Forceps (ST-SD, WM-FE,RR) V. Mueller Trephine (ST-CFE, WM-FE,RR) V. Mueller Forceps (ST-RR, WM-FE,RR) V. Mueller Mastoid (WM-FE,RR) V. Mueller Punch (WM-FE,RR) V. Mueller Neuro/Spine (ST-MF) V. Mueller Currette (WM-FE,RR) Affinity Scissors (ST-RR, WM-FE,RR) V. Mueller Scissors (ST-RR, WM-FE,RR) V. Mueller Tonsil Hook (WM-FE,RR) Snowden-Pencer MIS Suction Coagulator (WM-FE,RR) V. Mueller Magill Forceps (WM-FE,RR) V. Mueller Chest Tube Passer (ST-CFE) V. Mueller Nasal Snare (WM-FE,RR) V. Mueller Clamps (ST-SD, WM-FE,RR) V. Mueller Hemmorrhoidal Ligator (WM-FE,RR) V. Mueller Uterine Currette (ST-CFE, WM-FE,RR) V. Mueller Ear Scissors (ST-SD, WM-FE,RR) V. Mueller Neuro/Spine Rongeur (ST-SD, WM-FE, RR) V. Mueller Rongeur (ST-SD, WM-FE, RR) V. Mueller Nasal Currette (ST-SD, WM-FE,RR) V. Mueller Currette (ST-MF, WM-FE,RR) V. Mueller Pelvimeter (WM-FE,RR) V. Mueller Forceps (ST-RR , WM-FE,RR) Affinity Forceps (ST-RR) Snowden Pencer Forceps (WM-FE, RR) V. Mueller Bipolar Scissors (WM-FE,RR) V. Mueller RASP (ST-CFE,SD,WM-FE,RR) Affinity RASP (ST-CFE,SD, WM-FE,RR) V. Mueller Biopsy Forceps, Rayport Muscle Biopsy Clamp (ST-MF) V. Mueller Yeomans Biopsy Forceps & Price Muscle Biopsy Clamp (ST-SD, WM-RR,FE) V. Mueller Tonsil Punch (WM-FE,RR) V. Mueller Fistula Probe (ST-MF) V. Mueller Instrument Tip Protector (ST-MF) Snowden-Pencer Forceps (WM-FE,RR) V. Mueller Needle Holder (ST-MF, WM-FE,RR) V. Mueller LUER STUB ADAPTERS (WM-FE,RR) V. Mueller Clamp (WM-FE,RR) V. Mueller Pliers (ST-CFE, WM-FE,RR) V. Mueller Ear PIck (ST-MF, WM-FE,RR) V. Mueller Scalpel Handle (ST-MF, WM-FE,RR) V. Mueller Wire Cutter (ST-CFE, SD, WM-FE,RR) Snowden-Pencer Wire Cutter (ST-CFE,SD, WM-FE,RR) V. Mueller Ophthalmic Spatula (ST-MF, WM-FE,RR) V. Mueller Atomizer Spray (WM-FE,RR) V. Mueller Nasal Saw (ST-CFE, WM-FE,RR) Snowden-Pencer Nasal Saw (ST-CFE, WM-FE,RR) Snowden-Pencer Knife Handles (ST-MF) V, Mueller Knife Blades (ST-MF)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2024-07-01
KOE	Dilator, Urethral	Gastroenterology, Urology	Class 2	876.5520	2024-07-11
KCP	Syringe, Ent	Ear, Nose, Throat	Class 1	874.5220	2024-07-11
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2024-07-01
HOE	Caliper, Ophthalmic	Ophthalmic	Class 1	886.4350	2024-07-11
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2024-07-11
KBL	Depressor, Metal Tongue, Surgical	Ear, Nose, Throat	Class 1	874.4420	2024-07-01
KBQ	Knife, Tonsil	Ear, Nose, Throat	Class 1	874.4420	2024-07-11
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2024-07-11
EMK	Curette, Surgical, Dental	Dental	Class 1	872.4565	2024-07-11
HTX	Rongeur	Orthopedic	Class 1	888.4540	2024-07-10
JZF	Tube, Ear Suction	Ear, Nose, Throat	Class 1	874.4420	2024-07-01
HNI	Retractor, Ophthalmic	Ophthalmic	Class 1	886.4350	2024-07-01
KAL	Retractor, Ent	Ear, Nose, Throat	Class 1	874.4420	2024-07-01
FGM	Probe And Director, Gastro-Urology	Gastroenterology, Urology	Class 1	876.4730	2024-07-01
KBB	Rongeur, Nasal	Ear, Nose, Throat	Class 1	874.4420	2024-07-11
FFN	Clamp, Non-Electrical	Gastroenterology, Urology	Class 1	876.4730	2024-07-10
GEG	Elevator, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2024-07-01
HNH	Ring, Ophthalmic (Flieringa)	Ophthalmic	Class 1	886.4350	2024-07-11
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2024-07-01
HXT	Tape, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2024-07-11
KIK	Hook, Bone	General, Plastic Surgery	Class 1	878.4800	2024-07-01
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2024-07-01
HYA	Forceps, Wire Holding	General, Plastic Surgery	Class 1	878.4800	2024-07-01
HRQ	Hemostat	General, Plastic Surgery	Class 1	878.4800	2024-07-10
HXY	Brace, Drill	Orthopedic	Class 1	888.4540	2024-07-11
HNM	Needle, Ophthalmic Suturing	Ophthalmic	Class 1	886.4350	2024-07-11
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2024-07-11
HRR	Scissors, Orthopedic, Surgical	Orthopedic	Class 1	888.4540	2024-07-10
JYF	Clamp, Ossicle Holding	Ear, Nose, Throat	Class 1	874.4420	2024-07-11
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-07-11
GDR	Saw, Manual And Accessories	General, Plastic Surgery	Class 1	878.4800	2024-07-11
FER	Anoscope And Accessories	Gastroenterology, Urology	Class 2	876.1500	2024-07-10
HDA	Forceps, Obstetrical	Obstetrics/Gynecology	Class 2	884.4400	2024-07-10
HNB	Spoon, Ophthalmic	Ophthalmic	Class 1	886.4350	2024-07-10
KAS	Knife, Nasal	Ear, Nose, Throat	Class 1	874.4420	2024-07-01
KAT	Perforator, Antrum	Ear, Nose, Throat	Class 1	874.4420	2024-07-01
EFL	Forceps, Dressing, Dental	Dental	Class 1	872.4565	2024-07-11
HDE	Hook, Fibroid, Gynecological	Obstetrics/Gynecology	Class 1	884.4520	2024-07-11
JYL	Hook, Microsurgical Ear	Ear, Nose, Throat	Class 1	874.4420	2024-07-01
GZT	Retractor, Self-Retaining, For Neurosurgery	Neurology	Class 2	882.4800	2024-07-01
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2024-07-11
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2024-07-11
HFB	Forceps, Biopsy, Gynecological	Obstetrics/Gynecology	Class 1	884.4530	2024-07-10
GWY	Pinwheel	Neurology	Class 1	882.1750	2024-07-11
EZO	Urethrotome	Gastroenterology, Urology	Class 2	876.4770	2024-07-11
HDF	Speculum, Vaginal, Metal	Obstetrics/Gynecology	Class 1	884.4520	2024-07-10
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2024-07-01
HDC	Tenaculum, Uterine	Obstetrics/Gynecology	Class 2	884.4530	2024-07-11
EXX	Probe, Rectal, Non-Powered	Gastroenterology, Urology	Class 1	876.4730	2024-07-10
KBA	Rasp, Nasal	Ear, Nose, Throat	Class 1	874.4420	2024-07-01
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2024-07-11
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-07-11
KAD	Elevator, Ent	Ear, Nose, Throat	Class 1	874.4420	2024-07-01
KCG	Dilator, Tracheal	Ear, Nose, Throat	Class 1	874.4420	2024-07-11
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2024-07-11
JZD	Snare, Ear	Ear, Nose, Throat	Class 1	874.4420	2024-07-11
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2024-07-11
GWZ	Percussor	Neurology	Class 1	882.1700	2024-07-11
DWO	Needle, Biopsy, Cardiovascular	General, Plastic Surgery	Class 1	878.4800	2024-07-11
KOA	Surgical Instruments, G-U, Manual (And Accessories)	Gastroenterology, Urology	Class 1	876.4730	2024-07-11
HDK	Scissors, Episiotomy	Obstetrics/Gynecology	Class 1	884.4520	2024-07-11
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2025-07-19
HTE	Elevator	General, Plastic Surgery	Class 1	878.4800	2024-07-11
GEJ	Carrier, Ligature	General, Plastic Surgery	Class 1	878.4800	2024-07-01
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	2024-07-11
DRC	Trocar	Cardiovascular	Class 2	870.1390	2024-07-11
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2024-07-11
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2024-07-11
HBG	Drills, Burrs, Trephines & Accessories (Manual)	Neurology	Class 2	882.4300	2024-07-11
KBN	Gag, Mouth	Ear, Nose, Throat	Class 1	874.4420	2024-07-11
FFO	Retractor, Self-Retaining	Gastroenterology, Urology	Class 1	876.4730	2024-07-01
JZY	Knife, Laryngeal	Ear, Nose, Throat	Class 1	874.4420	2024-07-11
KAE	Forceps, Ent	Ear, Nose, Throat	Class 1	874.4420	2024-07-01
GAI	Stripper, Vein, Reusable	General, Plastic Surgery	Class 1	878.4800	2024-07-11
HXK	Holder, Needle; Orthopedic	Orthopedic	Class 1	888.4540	2024-07-11
HDP	Elevator, Uterine	Obstetrics/Gynecology	Class 2	884.4530	2024-07-11
HHM	Sound, Uterine	Obstetrics/Gynecology	Class 1	884.4530	2024-07-01
HNQ	Hook, Ophthalmic	Ophthalmic	Class 1	886.4350	2024-07-01
KBS	Punch, Adenoid	Ear, Nose, Throat	Class 1	874.4420	2024-07-11
JYR	Nipper, Malleus	Ear, Nose, Throat	Class 1	874.4420	2024-07-11
FGN	Retractor, Non-Self-Retaining	Gastroenterology, Urology	Class 1	876.4730	2024-07-01
KTZ	Caliper	Orthopedic	Class 1	888.4150	2024-07-01
LGG	Instrument, Cast Application/Removal, Manual	Orthopedic	Class 1	888.5980	2024-07-10
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2024-06-27
JYO	Knife, Ear	Ear, Nose, Throat	Class 1	874.4420	2024-07-01
EMI	File, Bone, Surgical	Dental	Class 1	872.4565	2024-07-11
HRT	Stripper, Surgical	Orthopedic	Class 1	888.4540	2024-07-10
FHA	Clamp, Penile	Gastroenterology, Urology	Class 1	876.5160	2024-07-01
HGC	Clamp, Uterine	Obstetrics/Gynecology	Class 1	884.4520	2024-07-10
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2024-07-01
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-07-11
HNW	Dilator, Lachrymal	Ophthalmic	Class 1	886.4350	2024-07-10
KOH	Instrument, Manual, General Obstetric-Gynecologic	Obstetrics/Gynecology	Class 1	884.4520	2024-07-01
FBX	Sound, Urethral, Metal Or Plastic	Gastroenterology, Urology	Class 1	876.5520	2024-07-01
KBD	Scissors, Nasal	Ear, Nose, Throat	Class 1	874.4420	2024-07-11
HCZ	Forceps, Surgical, Gynecological	Obstetrics/Gynecology	Class 2	884.4530	2024-07-11
HWK	Trephine	Orthopedic	Class 1	888.4540	2024-07-10
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-07-01
JZC	Searcher, Mastoid	Ear, Nose, Throat	Class 1	874.4420	2024-07-11
KAW	Punch, Antrum	Ear, Nose, Throat	Class 1	874.4420	2024-07-11
HAO	Instrument, Surgical, Non-Powered	Neurology	Class 1	882.4535	2024-07-01
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	2024-07-01
KBP	Hook, Tonsil Suturing	Ear, Nose, Throat	Class 1	874.4420	2024-07-11
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-07-11
BWB	Forceps, Tube Introduction	Anesthesiology	Class 1	868.5780	2024-07-10
KBE	Snare, Nasal	Ear, Nose, Throat	Class 1	874.4420	2024-07-10
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2024-07-10
FHN	Ligator, Hemorrhoidal	Gastroenterology, Urology	Class 2	876.4400	2024-07-11
HCY	Curette, Uterine	Obstetrics/Gynecology	Class 1	884.4530	2024-07-10
JZB	Scissors, Ear	Ear, Nose, Throat	Class 1	874.4420	2024-07-10
HAE	Rongeur, Manual	Neurology	Class 2	882.4840	2024-07-11
KAP	Curette, Nasal	Ear, Nose, Throat	Class 1	874.4420	2024-07-10
HNZ	Curette, Ophthalmic	Ophthalmic	Class 1	886.4350	2024-07-01
HER	Pelvimeter, External	Obstetrics/Gynecology	Class 1	884.4520	2024-07-11
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2024-07-01
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-07-11
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2024-07-11
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2024-07-01
KBT	Punch, Tonsil	Ear, Nose, Throat	Class 1	874.4420	2024-07-11
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2024-07-01
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2024-07-11
HTC	Pliers, Surgical	General, Plastic Surgery	Class 1	878.4800	2024-07-11
JYT	Pick, Microsurgical Ear	Ear, Nose, Throat	Class 1	874.4420	2024-07-01
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2024-07-01
HXZ	Cutter, Wire	Orthopedic	Class 1	888.4540	2024-07-10
HND	Spatula, Ophthalmic	Ophthalmic	Class 1	886.4350	2024-07-01
CCQ	Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	Anesthesiology	Class 1	868.5640	2024-07-11
KBC	Saw, Nasal	Ear, Nose, Throat	Class 1	874.4420	2024-07-10
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	2024-07-01

Official Correspondent

No official correspondent registered.

US Agent Details

Becky Aldhizer Business: STERIS Email: becky_aldhizer@steris.com Phone: (440) 4687462

Related Public Records

Same Entity

STERIS

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1526531	STERIS Corporation	CLEVELAND, OH, US
1923569	STERIS Corporation	Saint Louis, MO, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K914997	Conmedcorp	ASP-IRRATOR	1992-01-07
K153773	Olympus Medical Systems Corp.	Disposal Lens Cleaning Sheath	2016-11-22
K940141	Micro-Medical Devices, Inc.	LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH	1994-05-19
K933812	Advanced Surgical, Inc.	ADVANCED SURGICAL, INC. CANNULA CLEANING DEVICE AND ACCESSORIES	1993-12-13
K254228	Karl Storz SE & CO. KG	KARL STORZ Trocars with Valve Seals	2026-05-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.
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

Similar Registrations

Registration Number	Establishment Name	Location
3016804805	CLEARCAM	Austin, TX, US
3011936016	Sony Olympus Medical Solutions Inc.	Hachioji-shi Tokyo, JP
3015335150	VERNACARE LTD.	Chorley Lancashire, GB
1221072	VASCULAR TECHNOLOGY INCORPORATED	NASHUA, NH, US
3021744308	Lazurite Inc.	Cleveland, OH, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006554912. Last updated year: 2026. Please use registration number 3006554912 when referencing this establishment in official correspondence.