Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8043368

FEI Number

1000194896

Entity Name

PMS GmbH

City/State/Country

TUTTLINGEN Baden-Wurttemberg, DE

Establishment Address

KREUZSTRASSE 5, TUTTLINGEN Baden-Wurttemberg D-78532, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

PMS GmbH (Owner Number: 9000996)

Owner / Operator Contact Address

KREUZSTRASSE 5, --, TUTTLINGEN, DE-BW D-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
HWM	Osteotome	General, Plastic Surgery	Class 1	878.4800	2015-07-29
KTF	Punch, Ent	Ear, Nose, Throat	Class 1	874.4420	1992-08-07
FZS	Curette, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	1994-03-23
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	1999-04-15
HRH	Trephine, Manual, Ophthalmic	Ophthalmic	Class 1	886.4350	1994-03-23
JYC	Cannula, Ear	General, Plastic Surgery	Class 1	878.4800	1994-12-14
KAE	Forceps, Ent	Ear, Nose, Throat	Class 1	874.4420	1992-08-07
HSO	Saw	General, Plastic Surgery	Class 1	878.4800	1994-03-23
HNY	Cystotome	Ophthalmic	Class 1	886.4350	1998-09-29
HDL	Retractor, Vaginal	Obstetrics/Gynecology	Class 1	884.4520	1994-03-23
KTG	Knife, Ent	Ear, Nose, Throat	Class 1	874.4420	1992-08-07
HOE	Caliper, Ophthalmic	Ophthalmic	Class 1	886.4350	1998-09-29
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	1994-03-23
HWJ	Awl	Orthopedic	Class 1	888.4540	1994-12-14
HDF	Speculum, Vaginal, Metal	Obstetrics/Gynecology	Class 1	884.4520	1994-03-23
HNQ	Hook, Ophthalmic	Ophthalmic	Class 1	886.4350	1998-09-29
HND	Spatula, Ophthalmic	Ophthalmic	Class 1	886.4350	1994-03-23
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	1994-12-14
HNL	Probe, Lachrymal	Ophthalmic	Class 1	886.4350	1998-09-29
HNZ	Curette, Ophthalmic	Ophthalmic	Class 1	886.4350	1994-03-23
GAC	Rasp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1994-03-23
KAD	Elevator, Ent	Ear, Nose, Throat	Class 1	874.4420	1994-12-14
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	1998-09-29
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	1994-03-23
HNI	Retractor, Ophthalmic	Ophthalmic	Class 1	886.4350	1994-03-23
JYG	Curette, Ear	Ear, Nose, Throat	Class 1	874.4420	1992-08-07
FTX	Mirror, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1994-03-23
GDM	Needle, Aspiration And Injection, Reusable	General, Plastic Surgery	Class 1	878.4800	2015-07-29
JYQ	Loop, Wire	Ear, Nose, Throat	Class 1	874.4420	1994-12-14
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	1998-09-29
KBF	Trephine, Sinus	Ear, Nose, Throat	Class 1	874.4420	2015-07-29
KAM	Cannula, Sinus	General, Plastic Surgery	Class 1	878.4800	2015-07-29
HNC	Specula, Ophthalmic	Ophthalmic	Class 1	886.4350	1998-09-29
KAI	Mirror, Ent	Ear, Nose, Throat	Class 1	874.4420	2015-07-29
HNJ	Punch, Corneo-Scleral	Ophthalmic	Class 1	886.4350	1998-09-29
EPY	Speculum, Ent	General, Plastic Surgery	Class 1	878.1800	1994-12-14
HNW	Dilator, Lachrymal	Ophthalmic	Class 1	886.4350	1998-09-29
EMH	Forceps, Rongeur, Surgical	Dental	Class 1	872.4565	1994-03-23
JKL	Acid, Delta-Aminolevulinic, Ion-Exchange Columns With Colorimetry	Clinical Chemistry	Class 1	862.1060	1994-12-14
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	1998-09-29

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

PMS 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
K854401	Microsurgical Technology, Inc.	THE NEW MOBILE TIP MCINTYRE CANNULA	1985-12-30
K871646	Ocular Instruments, Inc.	TANNE CORNEAL CUTTING BLOCK	1987-05-18
K834189	Imm Enterprises , Ltd.	JAKOBI SURG. INSTRUMENTS #7 44/47	1984-03-06

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-0039-2018	Teleflex Medical	1	Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.
Z-0011-2019	Ellex iScience, Inc.	1	ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.
Z-0022-2009	Becton Dickinson and Company	1	BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery.
Z-0012-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Carbon Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417

Similar Registrations

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8010379	DEPUY INTL., LTD.	LEEDS, GB
9616671	DEPUY (IRELAND)	CO. CORK Munster, IE
3002862271	Wenzler Medizintechnik GmbH	Frittlingen Baden-Wurttemberg, DE
1926681	JEDMED Instrument Company	Saint Louis, MO, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8043368. Last updated year: 2026. Please use registration number 8043368 when referencing this establishment in official correspondence.