15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AVVIGO Guidance System
FDA 510(k)
FDA Class 2
·Cardiovascular
7450 RV2 MASK
FDA UDI
HANS RUDOLPH, INC.·00874750005123·ADULT X-SM 7450 MASK/HG/MA MFS
OsteoMed
FDA UDI
OSTEOMED LLC·00842528110669·1.3mm Drill, Quick Release, Short
STAT PROFILE PHOX PLUS C ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
HRW-42 WRIST ARRAY COIL FOR 1.0 TESLA
FDA 510(k)
FDA Class 2
·Radiology
CAPSUREFIX NOVUS MRI
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code NVN·August 11, 2011
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 27, 2014
SYNCHROMED II
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LKK·July 2, 2013
BD CATHENA¿ SAFETY IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·May 19, 2022
OPTIFLOW FILTERED NASAL INTERFACE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·February 11, 2025
323117
FDA Adverse Event
Malfunction
·HANDICARE USA·Product code FSA·December 12, 2017
OPTIFLOW FILTERED NASAL INTERFACE WITH CO2 SAMPLING
FDA Adverse Event
Injury
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·March 16, 2023
EMBLEM MRI S-ICD Model A219
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·February 17, 2021
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021