12 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197538343·Ikuta Bone Clamp 8 pointed theet jaw, fo
rked c...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197538329·Ikuta Bone Clamp 8 pointed theet jaw, fo
rked c...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197538350·Ikuta Bone Clamp 8 pointed theet jaw, fo
rked c...
AT HOME DRUG TESTT, MODEL 9150 T
FDA 510(k)
FDA Unclassified
·Unknown
MAHE PERFECT SPINE- PEDICLE SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 5, 2025
NEXGEN LPS-FLEX FEMORAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·August 10, 2011
ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NIQ·October 29, 2014
RIATA ST ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·July 8, 2013
EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180; designed for endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·October 7, 2015
ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017 S 2000 system 10441730 S 3000 system 10441701 S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015