Wallach Surgical Devices, Inc.
United StatesFDA applicant, unverified
- Devices
- 27
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
What Wallach Surgical Devices, Inc. makes
Wallach Surgical Devices, Inc. manufactures surgical instruments and electrosurgical systems, including the Wallach CC/Brush for endometrial sampling, the Wallach Flexible Endometrial Sampler for tissue collection, and the Wallach Loop Electrode for gynecological procedures. The company also produces imaging tools like the Wallach Digital Imaging System and Wallach Zoom Colposcope, as well as electrosurgical devices such as the Wallach Quantum 2000 System and Wallach Leap 100 Electrosurgery System. Additional offerings include the Photostar V-8 for diagnostic imaging, the Wallach Ultra Freeze for cryosurgical applications, and the Clean Air system for surgical environment control.
The company’s portfolio includes devices classified under FDA’s Class I and Class II categories, with submissions recorded in the FDA’s 510(k) registry. These products are intended for use in gynecological, surgical, and diagnostic procedures, with regulatory oversight governed by U.S. medical device regulations. The manufacturer is based in the United States.
Catalogue
Search and filter all 27 devicesFDA recalls
FDA recall records list 2 recalls initiated by Wallach Surgical Devices, Inc., initiated on 2007-06-06. By recorded status: 2 terminated. The reasons filed fall into these groups: mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2007
- 6 Jun 2007 Z-1045-2007 Unclassified (pre-2012) Terminated The tip may separate from the probe.
Full distribution text
- 6 Jun 2007 Z-1046-2007 Unclassified (pre-2012) Terminated The tip may separate from the probe.
Full distribution text
- 6 Jun 2007 Z-1045-2007 Unclassified (pre-2012) Terminated The tip may separate from the probe.
Frequently asked questions
How many devices does Wallach Surgical Devices, Inc. have in the registry?
The registry currently lists 27 devices for Wallach Surgical Devices, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Wallach Surgical Devices, Inc.'s devices?
Among its 27 most recently registered devices, Wallach Surgical Devices, Inc. has devices listed in FDA 510(k) (27 devices).
What risk classes do Wallach Surgical Devices, Inc.'s devices fall under?
Among its 27 most recently registered devices, the classes recorded for Wallach Surgical Devices, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Wallach Surgical Devices, Inc.?
FDA recall records list 2 recalls initiated by Wallach Surgical Devices, Inc., the most recent initiated on 6 Jun 2007. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Wallach Surgical Devices, Inc. in the registry?
The most recently registered devices listed for Wallach Surgical Devices, Inc. include `THE INSEMINATOR' (PROPOSED), WALLACH CC/BRUSH, PHOTOSTAR V-8 and WALLACH ULTRA FREEZE.