Ambu, Inc.
Linthicum, MD, US
Ambu, Inc. appears in FDA device records in Linthicum, MD. FDA records list 22 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 22
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 22 510(k) clearances for Ambu, Inc. between 1991 and 2004. The busiest year on record is 2004, with 7. The most recent is 2004, with 7.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1991 | 1 |
| 1992 | 4 |
| 1993 | 3 |
| 1995 | 1 |
| 1997 | 1 |
| 1998 | 1 |
| 1999 | 2 |
| 2000 | 1 |
| 2001 | 1 |
| 2004 | 7 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K042682 | AMBU SPUR II. ADULT SINGLE PATIENT RESUSCITATOR | BTM | Substantially Equivalent | |
| K042843 | AMBU SPUR II INFANT AND PEDIATRIC SINGLE PATIENT USE RESUSCITATORS | BTM | Substantially Equivalent | |
| K041734 | AMBU DISPOSABLE ECG ELECTRODE | DRX | Substantially Equivalent | |
| K040991 | AMBU DISPOSABLE PRESSURE MANOMETER | CAP | Substantially Equivalent | |
| K041026 | AMBU BLUE SENSOR, MRX, ECG ELECTRODE PRODUCT #:MRX-00-S | DRX | Substantially Equivalent | |
| K032278 | AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE | GXY | Substantially Equivalent | |
| K032421 | AMBU PEDIATRIC MULTI-FUNCTION DEFIBRILLATION ELECTRODE | MKJ | Substantially Equivalent | |
| K010583 | AMBU GEL, HYDROGEL BURN DRESSING | MGQ | Substantially Equivalent | |
| K993278 | AMBU NEONATE SILICONE RESUSCITATOR | BTM | Substantially Equivalent | |
| K992902 | AMBU HAND POWER SUCTION PUMP | BSY | Substantially Equivalent | |
| K982722 | AMBU MEDIBAG ADULT, AMBU MEDIBAG INFANT/CHILD | CAF | Substantially Equivalent | |
| K981891 | AMBU TUBECHECK | BTR | Substantially Equivalent | |
| K964584 | AMBU SPUR NEONATE | BTM | Substantially Equivalent | |
| K932031 | AMBU PORTABLE SUCTION UNIT | BTA | Substantially Equivalent | |
| K932014 | AMBU DISPOSABLE FACE MASK | BSJ | Substantially Equivalent | |
| K923762 | SPUR INFANT/CHILD W/O PRESSURE-LIMITING VALVE | BTM | Substantially Equivalent | |
| K923976 | AMBU SINGLE PATIENT USE PEEP VALVE | BYE | Substantially Equivalent | |
| K924216 | AMBU SILICONE RESUSCITATOR INFAN/CHILD W/OPEN RESO | BTM | Substantially Equivalent | |
| K924215 | AMBU SILICONE RESUSCITATOR, ADULT W/OPEN RESERVOIR | BTM | Substantially Equivalent | |
| K922712 | SPUR INFANT/CHILD WITH OPEN RESERVOIR SYSTEM | BTM | Substantially Equivalent | |
| K922707 | SPUR ADULT WITH OPEN RESERVOIR SYSTEM | BTM | Substantially Equivalent | |
| K914187 | AMBU SILICONE RESUSCITATOR INFANT/CHILD | BTM | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- BYEAttachment, Breathing, Positive End Expiratory Pressure
- MKJAutomated External Defibrillators (Non-Wearable)
- BSYCatheters, Suction, Tracheobronchial
- MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
- GXYElectrode, Cutaneous
- DRXElectrode, Electrocardiograph
- BSJMask, Gas, Anesthetic
- CAPMonitor, Airway Pressure (Includes Gauge And/Or Alarm)
- CAFNebulizer (Direct Patient Interface)
- BTAPump, Portable, Aspiration (Manual Or Powered)
- BTRTube, Tracheal (W/Wo Connector)
- BTMVentilator, Emergency, Manual (Resuscitator)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Ambu, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Ambu, Inc.. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.
Data as of , FDA export datePage updated Source: openFDA, public domain