18 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
HOVEROUND TEKNIQUE FWD MK4 POWER WHEELCHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
LEONE SPA
FDA UDI
LEONE SPA·08033707065630·INTRAORAL ELASTICS 2,5 oz 1/8" brown
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690189626·6+ FEMUR / 7 TIBIA TRIALS INSTRUMENT PAN
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036027025·
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0101080·Distractor, Smooth Paddle, 8mm
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690189619·AK3 6+ Femur/7 Tibia Instrument pan insert
TiWAVE L Lumbar Cage System
FDA UDI
Kalitec Direct LLC·B07323K0101080·Distractor, Smooth Paddle, Lordotic, 8mm
USS-LINE EXTENSION
FDA 510(k)
FDA Class 2
·Orthopedic
RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·February 12, 2026
THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER
FDA Adverse Event
Malfunction
·THORATEC CORPORATION·Product code DSQ·October 10, 2024
UNKNOWN LINER
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·February 10, 2015
CURRENT PLUS VR, DF4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 2, 2013
PANORAMA CENTRAL STATION WITH TELEMETRY
FDA Adverse Event
Malfunction
·MINDRAY DS USA, INC.·Product code MHX·August 18, 2014
HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 16, 2011
BD ALARIS¿ EXTENSION SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·November 24, 2021
UNSPECIFIED BD INFUSION SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·December 22, 2022
Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024