19 results · 29ms · Sources: EU EUDAMED, 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