388 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System
FDA 510(k)
FDA Class 2
·Neurology
K-Systems
FDA UDI
Coopersurgical, Inc.·00888937025040·G73 Dry Bath Incubator
N/A
FDA UDI
PENTAX OF AMERICA, INC.·04961333242603·25 FT SVGA HD-15 MALE TO MALE CABLE
Ambler Surgical
FDA UDI
AMBLER SURGICAL CORP.·00190660194666·Corneal trephine blade, short, 8.0mm length, 6....
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197530354·Ferreira Style Breast Retractor
220x25...
SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV
FDA 510(k)
FDA Class 2
·Microbiology
8800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·October 31, 2008
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·July 15, 2011
IMPAX CV REPORTING
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP·Product code LLZ·July 8, 2013
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
3T HEATER/COOLER
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DWC·March 19, 2026
INTROCAN SAFETY®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code DYB·April 11, 2025
IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM
FDA Adverse Event
Malfunction
·ZIMMER DENTAL·Product code DZE·January 29, 2021
HEATER-COOLER SYSTEM
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DWC·October 1, 2025
HEATER-COOLER SYSTEM
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND GMBH·Product code DWC·April 30, 2026
HEATER-COOLER SYSTEM 3T
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND GMBH·Product code DWC·October 10, 2025
HEATER COOLER 3T SYSTEM
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DWC·December 3, 2025
HEATER-COOLER SYSTEM 3T
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DWC·October 10, 2025
HEATER COOLER 3T SYSTEM
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DTQ·April 22, 2026