13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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POWDER FREE VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
CapSure® Spine System
FDA UDI
Spine Wave, Inc.·10840642105322·PS3 Screw 8.5mm x 35mm
BALANCED KNEE SYSTEM REVISION OFFSET TIBIA
FDA 510(k)
FDA Class 2
·Orthopedic
BIO-RAD PLATELIA TOXO IGM TMB
FDA 510(k)
FDA Class 2
·Microbiology
STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 4
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·June 2, 2022
RHYTHMIA HDX
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQK·October 16, 2025
REWALK
FDA Adverse Event
Injury
·ARGO MEDICAL TECHNOLOGIES·Product code BXB·May 15, 2013
PLM A+ PLATINUM MODU
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·September 17, 2014
SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL
FDA Adverse Event
Malfunction
·STAAR SURGICAL COMPANY·Product code HQL·May 17, 2011
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
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
FDA Enforcement
Class I
·Ongoing·Covidien·November 8, 2023
EMBLEM S-ICD Model A209
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·February 17, 2021
Model Number L231, PROPONENT DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025