FDA Device Registration & Listing · DURCHHAUSEN Baden-Wurttemberg, DE · Registration 9611610
Normalized identity and public registration information from FDA records.
No proprietary names listed under this establishment.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| LRP | Tray, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2010-06-23 |
| EZB | Stylet For Catheter, Gastro-Urology | Gastroenterology, Urology | Class 1 | 876.5130 | 2013-02-18 |
| KAD | Elevator, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-10-24 |
| GAD | Retractor | General, Plastic Surgery | Class 1 | 878.4800 | 2007-07-30 |
| FHR | Needle, Gastro-Urology | General, Plastic Surgery | Class 1 | 878.4800 | 2025-11-28 |
| FZX | Guide, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2001-11-28 |
| JZD | Snare, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 1986-03-05 |
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 1998-09-16 |
| NBH | Accessories, Arthroscopic | Orthopedic | Class 1 | 888.1100 | 2022-10-19 |
| FZS | Curette, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2002-04-15 |
| HXW | Bender | Orthopedic | Class 1 | 888.4540 | 2016-11-23 |
| GDR | Saw, Manual And Accessories | General, Plastic Surgery | Class 1 | 878.4800 | 1986-06-10 |
| HXZ | Cutter, Wire | Orthopedic | Class 1 | 888.4540 | 2016-11-17 |
| GDM | Needle, Aspiration And Injection, Reusable | General, Plastic Surgery | Class 1 | 878.4800 | 2012-02-10 |
| JYQ | Loop, Wire | Ear, Nose, Throat | Class 1 | 874.4420 | 1990-01-12 |
| HTX | Rongeur | Orthopedic | Class 1 | 888.4540 | 2023-02-27 |
| KBZ | Snare, Tonsil | Ear, Nose, Throat | Class 1 | 874.4420 | 1986-03-05 |
| GEN | Forceps, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2002-04-23 |
| DQR | Cannula, Catheter | Cardiovascular | Class 2 | 870.1300 | 2014-02-12 |
| KBE | Snare, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 1986-03-05 |
| GAH | Stylet, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2013-01-30 |
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | Class 1 | 888.4540 | 2013-01-31 |
| DWS | Instruments, Surgical, Cardiovascular | Cardiovascular | Class 1 | 870.4500 | 2026-03-18 |
No official correspondent registered.
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K881095 | CooperVision, Inc. | KOI(TM) INSTRUMENT TRAYS | 1988-04-06 |
| 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 |
| K851170 | The Huxley Instrument Corp. | DISSECTING TWEEZER #283-72PCS. SS 410 | 1985-04-25 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0036-2010 | Alphatec Spine, Inc. | 1 | ROC Lumbar bolt caddy, Part Number: 81997-01-05.
Sterilization container for ROC bolts/screws. Product is used to contain spinal implants. |
| Z-0031-2014 | Aesculap, Inc. | 1 | UNITRAC Pneumatic Retraction Arm.
A support arm used to hold surgical instruments during surgical procedures. |
| Z-0040-2011 | Smith & Nephew, Inc. Endoscopy Division | 1 | Smith & Nephew Aimer Endofemoral 3mm Offset (Blue)
Catalog Number: 72201713
ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery. |
| Z-0041-2011 | Smith & Nephew, Inc. Endoscopy Division | 1 | Smith & Nephew Aimer Endofemoral 4mm Offset (Purple
Catalog Number: 72201714
ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery. |
| Z-0042-2011 | Smith & Nephew, Inc. Endoscopy Division | 1 | Smith & Nephew Aimer Endofemoral 5mm Offset (Red)
Catalog Number: 72201715
ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3002669946 | Owens & Minor Distribution Inc. OM45 | Sunrise, FL, US |
| 1646747 | WEXLER SURGICAL, INC. | HOUSTON, TX, US |
| 1037577 | ANGIOSYSTEMS, INC. | DUCKTOWN, TN, US |
| 3016171961 | HANGZHOU ALLINE PLASTIC CO., LTD. | HANGZHOU Zhejiang, CN |
| 3007485169 | MEDYSSEY CO., LTD. | Jecheon-si Chungbuk, KR |
9611610 when referencing this establishment in official correspondence.