19 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYNTHES (USA) LCP PROXIMAL FEMUR HOOK PLATES
FDA 510(k)
FDA Class 2
·Orthopedic
AOS CANCELLOUS LAG SCREW 4.0mm x 32mm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665009507·
ihcDirect® Cytokeratin 20 Ab
FDA UDI
NOVODIAX, INC.·00850000596429·Clone R1001
ihcDirect® Cytokeratin 20 Ab
FDA UDI
NOVODIAX, INC.·00850000596436·Clone R1001
ihcDirect® Cytokeratin 20 Ab Conjugate 5mL
FDA UDI
NOVODIAX, INC.·00850030934178·Clone R1001
ihcDirect® Cytokeratin 20 Ab Conjugate 15mL
FDA UDI
NOVODIAX, INC.·00850030934185·Clone R1001
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710420320320·Anterio Lateral Wedge Osteotomy Guide, 32mm x 32mm
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710410320320·Anterior Closing Wedge Osteotomy Guide, 32mm x ...
C02 LASER MULTIPULSE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FIRST SPEP
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·February 8, 2023
APHIS PLATEAU RADIAL T1
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code JWJ·May 19, 2017
TOTALCARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·March 6, 2013
ROTATING MULTIPLE CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·March 28, 2011
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·April 21, 2008
EVOLUT FX VALVE
FDA Adverse Event
Injury
·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·August 27, 2025
UC-PLUS Solution Unicondylar Knee System, Model Numbers: 26014 Femoral Component Size 4, 26016 Femoral Component Size 6, 26018 Femoral Component Size 8 and 26020 Femoral Component Size 10
FDA Recall
Terminated
·Plus Orthopedics USA·Product code HRY·July 18, 2006
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
FDA Enforcement
Class I
·Ongoing·Thoratec Corp.·May 8, 2024