16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACTOVOX DUO2 OXYGEN CONCENTRATOR SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814688·GENUMEDI SILVER SIZE V
Peerless Buccal Tube
FDA UDI
ORMCO CORPORATION·00889989053593·PEERLESS 2NDMOL 6DEG LR NDX-27TX022
NexxZr™ T / D-100-22-NT-OM30-SD
FDA UDI
SAGEMAX BIOCERAMICS, INC·00842271114150·
INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
FDA Adverse Event
Injury
·MSD DEGGENDORF MFG·Product code OVD·December 18, 2019
CLYDESDALE PTC SPINAL SYSTEM
FDA Adverse Event
Injury
·MSD DEGGENDORF MFG·Product code MAX·October 17, 2019
RADIANCY ACNE SYSTEM WITH CLEARTOUCH LIGHT UNIT ASSEMBLY
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SNORERX 9.0
FDA 510(k)
FDA Class 2
·Dental
AEQUALIS REVERSED BASE PLATE TA6V LONG PEG WITH HA
FDA Adverse Event
Injury
·TORNIER S.A.S.·Product code KWS·April 19, 2023
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 29, 2013
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code LWS·October 1, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Other
·INVACARE·Product code ITI·June 6, 2011
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code NKB·April 19, 2019
syngo.via RT Image Suite with syngo.via VB30, VB40, VB50 and VB60- Intended for Radiation Therapy Treatment Material Number: 10496180
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·September 22, 2021
Depuy SIGMA RP TC3 insert; polyethylene tibial insert, Sz 2.5, 10.0 mm; Ref 96-2331.
FDA Recall
Terminated
·Depuy Orthopaedics, Inc.·Product code NJL·May 26, 2005
Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Allura Xper FD10, Model Number 722003 2. Allura Xper FD10/10, Model Number 722005 3. Allura Xper FD20, Model Number 722006 4. Allura Xper FD20 Biplane, Model Number 722008 5. Allura Xper FD10, Model Number 722010 6. Allura Xper FD10/10, Model Number 722011 7. Allura Xper FD20, Model Number 722012 8. Allura Xper FD20 Biplane, Model Number 722013 9. Allura Xper FD20 OR Table, Model Number 722023 10. Allura Xper FD10, Model Number 722026 11. Allura Xper FD10/10, Model Number 722027 12. Allura Xper FD20, Model Number 722028 13. Allura Xper FD20/10, Model Number 722029 14. Allura Xper FD20 OR Table, Model Number 722035 15. Allura Xper FD20/20, Model Number 722038 16. Allura Xper FD20/15, Model Number 722058 17. Allura Xper FD20/15 OR Table, Model Number 722059.
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·September 10, 2025