Manufacturer registered with FDA
Robert Busse & Co., Inc.
HAUPPAUGE, NY, United States. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 6190 registrations outside the US
- Establishments
- 1United States
Registered in 6 markets
Where regulators' registries name Robert Busse & Co., Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Robert Busse & Co., Inc. | 1 device types | — | Below |
| Canada | Health Canada | Registration holder | BUSSE HOSPITAL DISPOSABLES | 124 | 1999–2025 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | BUSSE HOSPITAL DISPOSABLES, INC.BUSSE HOSPITAL DISPOSABLES · Busse Hospital Disposables | 40 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | BUSSE HOSPITAL DISPOSABLES | 23 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Busse Hospital Disposables, Inc. | 2 | 2016–2016 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | BUSSE HOSPITAL DISPOSABLES, INC | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Robert Busse & Co., Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Maker | ALL PURPOSE BULB SYRINGE | 1996 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| BUSSE HOSPITAL DISPOSABLESFDA reg. 2433012 | HAUPPAUGE, NY, United States | Manufacturer |
Other names on FDA records
Busse Hospital Disposables, Inc.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 2417536). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.