13 results
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17ms
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Sources: EU EUDAMED, US FDA
REPCO EASY-BREATHER CLINICAL AIR PUMP
FDA 510(k)
FDA Class 2
·Anesthesiology
Tranquil-C™
FDA UDI
NEXUS SPINE, L.L.C.·B6788225120·Cervical Trial 9x16x13, 12 deg Lordotic
APEX PS Knee
FDA UDI
Omni Life Science, Inc.·00841690113720·PS-C Insert, Size 5 x 12mm
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011822512400·Ortho-Cast M-Series 22, Buccal tubes -10°Torque...
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011822512300·Ortho-Cast M-Series 22, Buccal tubes -10°Torque...
CS2 HIP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518
FDA 510(k)
FDA Class 1
·Hematology
OPT SLEEVE 12X100 STABILITY
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·September 24, 2019
BOLT Ø4.9 SELF-TAP L34 SST
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code KTT·November 7, 2012
PROMUS ELEMENT? PLUS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·May 21, 2014
LCS COMP RP INSERT STD 10MM
FDA Adverse Event
Injury
·DEPUY-RAYNHAM, A DIV OF DEPUY ORTHOPAEDICS·Product code NJL·August 27, 2010
GEHC OEC Injection Cable for MedRad Provis V Contrast Injector. In certain fluoroscope X-ray modes, the cable provides a signal to the auto-injector to trigger a contrast injection. Part numbers include 00-902260-01 and 00-883654-01.
FDA Enforcement
Class II
·Terminated·GE OEC Medical Systems, Inc·August 29, 2012
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025