17 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ECHELON LINEAR 60 mm Cutter (GLC60);ECHELON LINEAR 80mm Cutter (GLC80);ECHELON LINEAR 100 mm Cutter (GLC100);ECHELON LINEAR Cutters 60mm Blue Reload (GLCR60B);ECHELON LINEAR Cutters 60mm Green Reload (GLCR60G);ECHELON LINEAR Cutters 80mm Blue Reload (GLCR80B);ECHELON LINEAR Cutters 80mm Green Reload (GLCR80G);ECHELON LINEAR Cutters 100mm Blue Reload (GLCR100B);ECHELON LINEAR Cutters 100mm Green Reload (GLCR100G)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Universal Ryno Lacer II Long
FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357237609·
M/DN®
FDA UDI
Zimmer, Inc.·00889024039865·
DURALOC
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295106791·DURALOC SCREW-IN TRIAL LINER 28mm ID 60mm OD 10...
CT CARDIAC FUNCTION ANALYSIS SOFTWARE, MODELS CSCF-001A AND CSCF-001B
FDA 510(k)
FDA Class 2
·Radiology
MULTIPLE NAME
FDA 510(k)
FDA Class 1
·General Hospital
MICROPLASTY TIBIAL TRAYS- LOCKING BAR
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·April 18, 2017
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 25, 2011
HUT EXT DR FINALY ASSY-REVERSE
FDA Adverse Event
Malfunction
·LIEBEL-FLARSHEIM BUSINESS·Product code IXR·August 5, 2014
GRANUFLO
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·July 10, 2013
NEXTAR SPINE
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code OLO·March 28, 2024
MCK MAXIMUM CONGRUENT KNEE KNEE SYSTEM- BEARING
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·April 18, 2017
i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
FDA Recall
Open, Classified
·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025
i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
FDA Enforcement
Class II
·Ongoing·Abbott Point Of Care Inc.·September 24, 2025
MAX PS DCM TIB BRNG 10X63/67MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·April 20, 2017
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026