46 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Bur PM2-70 50K Carb Ø1.0
FDA UDI
Bien-Air Surgery SA·07630055502391·
Dark Star Deformity
FDA UDI
Republic Spine, LLC·B0751002630·Rod Gripper Dual Action
CLC FAST DETERGENT 1 ALKALINE WASHING SOLUTION 100263
FDA UDI
CAROLINA LIQUID CHEMISTRIES CORPORATION·00817302024029·Alkaline Wash Solution (ALK)
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450021965·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450048313·
GO MEDICAL BALLOON INFUSION SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
REMSTAR PLUS CPAP SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
M-SERIES DC POWER SUPPLY
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·May 25, 2012
PATIENT INFORMATION CENTER IX
FDA Adverse Event
Malfunction
·PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH·Product code MHX·April 3, 2026
REMSTAR AUTO M SERIES
FDA Adverse Event
Injury
·RESPIRONICS, INC.·Product code BZD·April 14, 2024
WAVEWRITER ALPHA? 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·April 2, 2025
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·May 8, 2013
HARMONIC FOCUS CURVED SHEARS, TORQUE WRENCH AND GRIP ASSIST
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code LFL·August 5, 2008
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·May 16, 2011
syngo.plaza, Model number 10592457. Intended use: radiological image processing system.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 5, 2012
Synthes Battery Power Line II Oscillator Model 530.710, orthopedic surgical power tool.
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·August 12, 2015
Siemens syngo.plaza radiological image processing system.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·October 17, 2012
Siemens syngo.plaza image processing system image processing radiological system
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·November 20, 2013
Syngo.plaza; picture archiving and communications system Product Usage: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza also supports storage and archiving of DICOM Structured reports. In a comprehensive imaging syngo.plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows. Syngo.plaza optionally uses a variety of advanced postprocessing applications.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 9, 2015