20 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SPIRUS MEDICAL ENDO-EASE ENDOSCOPIC OVERTUBE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Molift
FDA UDI
Etac A/S·05707995036070·
Berman Airways
FDA UDI
MERCURY ENTERPRISES, INC.·10641043800508·
VADER Pedicle System, Rod, Ti, straight, Ø 6.0 r000 x 500 mm
FDA UDI
icotec AG·07640164847276·VADER Pedicle System, Rod, Ti, straight, Ø 6.0 ...
Persona® PPS®
FDA UDI
Zimmer, Inc.·00889024631007·
Persona® PPS®
FDA UDI
Zimmer, Inc.·00889024630994·
TOP QUALITY CHLORINATED-POWDERFREE EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
ADVIA CENTAUR AND ACS: 180 FOLATE IMMUNOASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SEE H10
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code NBC·April 18, 2013
POWERED PATIENT ROTATION BED
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code IKZ·April 26, 2013
FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL, INC.·Product code KNS·April 6, 2011
POLYFLUX LR CAPILLARY DIALYZER
FDA Adverse Event
Malfunction
·GAMBRO DIALYSATOREN GMBH·Product code MSF·July 24, 2008
M2A MAGNUM MODULAR HEAD 50MM HEAD DIAMETER
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·December 29, 2016
M2A MAGNUM TRI-SPIKE CUP 56MM OD X 50MM ID
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·December 29, 2016
PIPELINE FLEX W/SHIELD TECHNOLOGY
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·December 8, 2025
PIPELINE FLEX W/SHIELD TECHNOLOGY
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·December 8, 2025
PIPELINE FLEX W/SHIELD TECHNOLOGY
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·December 8, 2025
Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.
FDA Enforcement
Class I
·Terminated·Dexcom Inc·April 20, 2016
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014
OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021