12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Spine Wave Anterior Cervical Spine System
FDA 510(k)
FDA Class 2
·Orthopedic
NC/RC Analog for screw-retained abutment
FDA UDI
BIO CONCEPT Co., Ltd.·06947600303831·
JEWELERS BIPOLAR FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896000261·JEWELERS BIPOLAR FORCEPS STRAIGHT #4 COATED
JEWELERS BIPOLAR FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·B0991627600·JEWELERS BIPOLAR FORCEPS STRAIGHT #4 COATED
ORI F6T DRY ECG MONITORING ELECTRODE
FDA 510(k)
FDA Class 2
·Cardiovascular
ATLAS HOME PREGNANCY TEST (MIDSTREAM FORMAT) MODEL 70172001
FDA 510(k)
FDA Class 2
·Clinical Chemistry
V.A.C.ULTA THERAPY SYSTEM
FDA Adverse Event
Injury
·KINETIC CONCEPTS, INC.·Product code OMP·July 23, 2021
FREESTYLE NAVIGATOR
FDA Adverse Event
Malfunction
·Product code LFR·July 14, 2011
IMPAX CV REPORTING
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP.·Product code LLZ·June 11, 2013
ENDURON NEUT 48OD X 28ID
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code HRY·September 15, 2008
Inserter for Titanium Elastic Nails (TEN), orthopedic device
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·October 21, 2015
Synthes Inserter for Titanium Elastic Nails; The Inserter for Titanium Elastic Nails (TEN) is intended for fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is paramount. This includes: lower extremity fractures in pediatric and small-statured patients and upper extremity fractures in patients. This system is also intended to treat metaphyseal and episphyseal fractures, such as radial neck fractures, and is intended for fixation of small long bones, such as carpal and tarsal bones. In pediatric applications, the flexibility of the elastic nail allows it to be inserted at a point which avoids disruption of the bone growth plate.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·March 18, 2015