Ambu, Inc.
Ambu, Inc. holds FDA 510(k) medical device clearances, first cleared 1984, most recent 2005, with 7 FDA device recalls on record.
Top product codes for Ambu, Inc.
FDA recalls by Ambu, Inc.
- Z-2181-2025 — Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult, Catalog Number: 523211000 2 SPUR II Adult Resuscitator w/Mercury Filter, Adult, Catalog Number: 523611051 3 SPUR II Adult Resuscitator, Single Patient Use Resuscitator, Adult, Catalog Number: 523611057 4 SPUR II Adult Resuscitator, Single Patient Use Resuscitator, Adult, Catalog Number: 524611000 5 SPUR II Adult Resuscitator, Pop-off open 40 ,w/PEEP Valve 20, Adult, Catalog Number: 524611001 6 SPUR II Adult Resuscitator w/PEEP Valve 20, Adult, Catalog Number: 524611011 7 SPUR II Adult Resuscitator w/Pressure Limiting Valve, Adult, Catalog Number: 524611031 8 SPUR II Adult Resuscitator w/Pressure Limiting Valve, Adult, Catalog Number: 524611047 9 SPUR II Adult Resuscitator, Single Patient Use Resuscitator, Adult, Catalog Number: 524611051 10 SPUR II Pediatric Resuscitator w/10 O2 tube & Manometer, Catalog Number: 530200016 11 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530212000 12 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530212001 13 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530213000 14 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530213001 15 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530213011 16 SPUR II Pediatric Resuscitator w/Manometer, Pediatric, Catalog Number: 530213030 17 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530213031 18 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530213048 19 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530214000 20 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530613000 21 SPUR II Pediatric Resuscitator w/Manometer & PEEP Valve 20, Pediatric, Catalog Number: 530613031 22 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530613071 23 SPUR II Pediatric Resuscitator w/PEEP Valve 20,Manometer & CO2 Detector, Pediatric, Catalog Number: 530613831 24 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530614017 25 SPUR II Pediatric Resuscitator w/Manometer, Pediatric, Catalog Number: 530614030 26 SPUR II Pediatric Resuscitator w/CO2 Detector, Pediatric, Catalog Number: 530614800 27 SPUR II Pediatric Resuscitator, INF& TOD W/Manometer, Pediatric, Catalog Number: 530615030 28 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530619031 29 SPUR II Pediatric Resuscitator w/Expiratory Filter, Manometer PEEP Valve, Pediatric, Catalog Number: 531600051 30 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 531613000 31 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 531613001 32 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 531613010 33 SPUR¿ II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 531613031 34 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 531613047 35 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number:531613051 36 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 531614026 37 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 531638000 38 SPUR II Adult Resuscitator, Single Patient Use Resuscitator, Adult, Catalog Number: 523611051E 39 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number:530213000B The Ambu SPUR II Resuscitator is a single patient use resuscitator intended for pulmonary resus
- Z-1723-2025 — Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US
- Z-0261-2025 — Ambu¿ VivaSight 2 DLT Endobronchial tube, 35 FR (Catalog Number 412351000), 37 Fr (Catalog Number 412371000), 39 Fr (Catalog Number 412391000), 41 Fr (Catalog Number 412411000)
- Z-0714-2024 — Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2
- Z-2628-2023 — Ambu aView 2 A Monitor-The Ambu aView 2 Advance is intended to display live imaging data from compatible Ambu visualization devices, portable endoscopy system. Catalog No: 405011000
- Z-1420-2022 — Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and repositioning. Catalog numbers 412351000, 412371000, 412391000, 412411000
- Z-1236-2016 — Ambu, Aura Gain - Single Use Laryngeal Mask- Sterile for use as an alternative to a face mask for achieving and maintaining control of the airway during routine emergency anesthetic procedures.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Ambu, Inc.
- K051529 — AMBU NEUROLINE GROUND
- K042682 — AMBU SPUR II. ADULT SINGLE PATIENT RESUSCITATOR
- K042843 — AMBU SPUR II INFANT AND PEDIATRIC SINGLE PATIENT USE RESUSCITATORS
- K041734 — AMBU DISPOSABLE ECG ELECTRODE
- K040991 — AMBU DISPOSABLE PRESSURE MANOMETER
- K041026 — AMBU BLUE SENSOR, MRX, ECG ELECTRODE PRODUCT #:MRX-00-S
- K032278 — AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE
- K032421 — AMBU PEDIATRIC MULTI-FUNCTION DEFIBRILLATION ELECTRODE
- K010583 — AMBU GEL, HYDROGEL BURN DRESSING
- K993278 — AMBU NEONATE SILICONE RESUSCITATOR
- K992902 — AMBU HAND POWER SUCTION PUMP
- K982722 — AMBU MEDIBAG ADULT, AMBU MEDIBAG INFANT/CHILD
- K981891 — AMBU TUBECHECK
- K964584 — AMBU SPUR NEONATE
- K932031 — AMBU PORTABLE SUCTION UNIT
- K932014 — AMBU DISPOSABLE FACE MASK
- K923762 — SPUR INFANT/CHILD W/O PRESSURE-LIMITING VALVE
- K923976 — AMBU SINGLE PATIENT USE PEEP VALVE
- K924215 — AMBU SILICONE RESUSCITATOR, ADULT W/OPEN RESERVOIR
- K924216 — AMBU SILICONE RESUSCITATOR INFAN/CHILD W/OPEN RESO
- K922707 — SPUR ADULT WITH OPEN RESERVOIR SYSTEM
- K922712 — SPUR INFANT/CHILD WITH OPEN RESERVOIR SYSTEM
- K914187 — AMBU SILICONE RESUSCITATOR INFANT/CHILD
- K904920 — AMBU MATIC AUTOMATIC RESUSCITATOR
- K910040 — AMBU SIR 2 (SILICONE RESUSCITATOR), ADULT
- K902261 — AMBU SPUR (SINGLE PATIENT USE RESUSCITATOR) INFANT
- K900260 — AMBU LIFE KEY AND AMBU RES-CUE KEY
- K883434 — AMBU SPUR (SINGLE PATIENT USE RESUSCITATOR)
- K883433 — AMBU TWIN PUMP - (MANUAL SUCTION PUMP)
- K873579 — AMBU RMT VALVE
- K851194 — AMBU CPAP SYSTEM
- K844149 — AMBU RUBEN CIRCLE ANESTHESIA SYSTEM
- K840349 — MARK III RESUSCITATOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.