Alm Surgical Equipment, Inc.
United StatesFDA applicant, unverified
- Devices
- 10
What Alm Surgical Equipment, Inc. makes
Alm Surgical Equipment, Inc. manufactures surgical lighting systems, including fiber optic headlights like the BFW Wehmertite IV-A, xenon light sources such as the Angenioux StarPoint XE, and wall-mounted workplace illumination like the Dragers Gemina. Their portfolio also includes operating room lighting solutions, including the Prismalix (PRX) surgical lamp, surgical lamps, and illuminator series light systems. The company produces surgical tables and related systems, such as the Dragers DVE 8000/81/82 series with compatible DVE 4000/4001/4002 components.
The company’s devices are classified under FDA regulations as Class I or Class II, with submissions recorded in the FDA’s 510(k) clearance database. These products are intended for use in surgical environments and are subject to U.S. medical device regulations. The manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Drager Gemina Wall-Mounted Workplace Ref K961886
Regimes: 510(k) Registry: 510(k)Bfw Wehmerlite Iv-A Fiber Optic Surg. Headlight Ref K921848
Regimes: 510(k) Registry: 510(k)Drager Dve 4000 Series System Ref K921297
Regimes: 510(k) Registry: 510(k)Mta:angenieux Starpoint Xe Xenon Light Source Ref K945102
Regimes: 510(k) Registry: 510(k)Alm Operating Tables Ref K884019
Regimes: 510(k) Registry: 510(k)Alm Prismalix (Prx) Surgical Light Ref K982063
Regimes: 510(k) Registry: 510(k)Alm Surgical Lamps Ref K882613
Regimes: 510(k) Registry: 510(k)Alm Illuminator Series Light System Ref K922409
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Alm Surgical Equipment, Inc. have in the registry?
The registry currently lists 10 devices for Alm Surgical Equipment, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Alm Surgical Equipment, Inc.'s devices?
Among its 10 most recently registered devices, Alm Surgical Equipment, Inc. has devices listed in FDA 510(k) (10 devices).
What risk classes do Alm Surgical Equipment, Inc.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for Alm Surgical Equipment, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Alm Surgical Equipment, Inc. in the registry?
The most recently registered devices listed for Alm Surgical Equipment, Inc. include DRAGER DVE 8080/81/82 WITH DVE 4002 OR DVE 4001 SERIES SYSTEM, DRAGER GEMINA WALL-MOUNTED WORKPLACE, BFW WEHMERLITE IV-A FIBER OPTIC SURG. HEADLIGHT and DRAGER DVE 4000 SERIES SYSTEM.