17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LILLIPUP PMP, LILLIPUT PMP INTEGRATED
FDA 510(k)
FDA Class 2
·Cardiovascular
D902 LILLIPUT ECMO M PHISIO
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·April 7, 2022
LILLIPUP PMP, LILLIPUT PMP INTEGRATED
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·June 27, 2022
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100226·THORLAKSON ASPIRATING SPECULUM
1.5 MM SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036086381·
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100219·LIEBERMAN ASPIRATING SPECULUM K-WIRE
MaxFuse,VBR, 12 (D) x 14 (W) x 12 (H)
FDA UDI
Pioneer Surgical Technology, Inc.·00846468055875·12 (D) x 14 (W) x 12 (H)
LIPCOLLECTOR II
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
JBAIDS ANTHRAC DETECTION SYSTEM
FDA 510(k)
FDA Class 2
·Microbiology
ILAB? POLARIS MULTI-MODALITY GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQK·May 14, 2026
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 8, 2014
VITALITY
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 6, 2011
ALTRX +4 10D 36IDX52OD
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code LPH·June 7, 2013
TRULIANT TIB IMP PS INSERT SZ 4 11MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·February 4, 2025
ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
Medical Linear Accelerator
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·September 14, 2016
Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722223, (2) 722224, (3) 722225, (4) 722226
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024