20 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SNAP WOUND CARE SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NA
FDA UDI
Smith & Nephew, Inc.·03596010042965·BRISTOW/BANKHART SOFT TISSUE RETRACT
ProSplints
FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357130320·
Comprehensive® Shoulder System
FDA UDI
Biomet Orthopedics, LLC·00880304212206·
8940 MASK
FDA UDI
HANS RUDOLPH, INC.·00817136020631·8940 ADULT SM MASK W/1410A 2W
Comprehensive Shoulder System
FDA UDI
Biomet Orthopedics, LLC·00880304681033·
Neo
FDA UDI
Life Spine, Inc.·00190837035310·NEO 4-5 Level ACP Block
ESG-400 MODEL WB95051N, FOOTSWITCH DOUBLE PEDAL MODEL WB50402W, FOOTSWITCH SINGLE PEDAL MODEL WB50403W, P-CORD MODEL MAJ
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PHYSIOLOG, SERIES 95000
FDA 510(k)
FDA Class 2
·Cardiovascular
SCHILLER
FDA Adverse Event
Malfunction
·SCHILLER AG·Product code MHX·November 2, 2006
QUATTRODE
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·May 9, 2013
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code FNL·September 24, 2014
LIGASURE IMPACT
FDA Adverse Event
Malfunction
·COVIDIEN LP (VALLEYLAB)·Product code GEI·May 25, 2011
RETRACTA DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Malfunction
·COOK INC·Product code KRD·January 19, 2017
HYBRID(TM) GLENOID BASE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBF·October 9, 2024
Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001; V+O+C+S+N+Pro/Japan/PRT-00490-100; V+C+Pro/English/PRT-00900-001; V+C+Pro/Japan/PRT-00900-100; V+C/English/PRT-01098-000; V+O+C+S+N/English/PRT-01100-000; V+O+C+S+N/English/PRT-01100-001;
FDA Enforcement
Class II
·Ongoing·Ventec Life Systems, Inc.·June 30, 2021
SmartPath to dStream for 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·November 29, 2023
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
FDA Enforcement
Class I
·Ongoing·Covidien·November 8, 2023
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021