18 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
TRINIAS
FDA 510(k)
FDA Class 2
·Radiology
SMARTLOCK
FDA UDI
Stryker Leibinger GmbH & Co. KG·04546540492005·LOCKING SCREW, CROSS-PIN
3DP Lumbar Interbody System
FDA UDI
Genesys Orthopedics Systems LLC·M719GL3DL1235080·Large 8-Degree 3DP LLIF - 12mm x 35mm
3DP Lumbar Interbody System
FDA UDI
Genesys Orthopedics Systems LLC·M719GL3DM1235080·Medium 8-Degree 3DP LLIF - 12mm x 35mm
Atoll™
FDA UDI
Seaspine Orthopedics Corporation·10889981052317·3.5mm x 8mm Poly Screw Assm. The Atoll OCT Spin...
Sochi
FDA UDI
Altus Spine, LLC·00843210166421·Polyaxial Screw, 3.5mm x 8mm
UNMIAX LAPAROSCOPIC INSTRUMENT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DACRYOCATH
FDA 510(k)
FDA Unclassified
·Unknown
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 20, 2025
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 17, 2013
INTERMATE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·September 26, 2014
SPRINT QUATTRO SECURE S
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·June 14, 2011
Integra CUSA excel. CEM Nosecone for CUSA EXcel System. The CEM Nosecone is intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator. Used in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·March 20, 2013
Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator The CUSA Electrosurgical Module (CEM) provides Desiccate Coagulation waveform electrosurgical capability to CUSA Excel handpieces. The CUSA handpiece with the CEM Nosecone works in conjunction with the Force FX generator in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·February 26, 2014
Artis Q floor- Model No. 10848280 Artis Q ceiling- Model No. 10848281 Artis Q biplane- Model No. 10848282 Artis Q zeego- Model No. 10848283 Artis Q.zen floor- Model No. 10848353 Artis Q.zen ceiling- Model No. 10848354 Artis Q.zen biplane- Model No. 10848355
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·September 7, 2022
System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee multi-purpose 10094139 Artis zee biplane 10094141 Artis zeego 10280959 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zeego 10848283 Artis Q.zen floor 10848353 Artis Q.zen ceiling 10848354 Artis Q.zen biplane 10848355 Fluoroscopic X-Ray System
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·February 8, 2023
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
FDA Enforcement
Class I
·Ongoing·Covidien·November 8, 2023
Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025