2,454 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VivAer Stylus
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FOMON DORSAL SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896054721·FOMON DORSAL SCISSORS BEVELED BLADES POWER CUT ...
K-Wire
FDA UDI
Treace Medical Concepts, Inc.·00810111223829·1.6MM x 130MM LONG TARGETING WIRE
OsteoMed
FDA UDI
OSTEOMED LLC·00845694006385·0.9mm Pilot Drill, OSTEOPOWER
3200-300 Hoof Sensor
FDA UDI
Tekscan, Inc.·B97032003000·3200-300 Hoof Sensor
Integra® Miltex®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780169710·Integra® Miltex® Tray - 4" x 8" Single Layer Tr...
LARVAL DEBRIDEMENT THERAPY PRODUCTS - LARVAE 100/200/300 AND BIOBAG 50/100/200/300/400
FDA 510(k)
FDA Unclassified
·Unknown
NORTHWESTERN GATED BLOOD POOL SPECT (NUMUGAS)
FDA 510(k)
FDA Class 2
·Radiology
LIGHTSPEED 2.0CT SCANNER SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
DG 200/300 DIGITAL ANGIOGRAPHIC SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
CSD 200/300/400/500 DYNAMOMETER
FDA 510(k)
FDA Class 2
·Orthopedic
DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400
FDA 510(k)
FDA Class 2
·Cardiovascular
DINAMAP PROCARE SERIES MONITOR; MODEL 100, 200, 300, 400
FDA 510(k)
FDA Class 2
·Cardiovascular
ACL SYSTEMS 100, 200, 300 AND 300+ COAGULATION SYS
FDA 510(k)
FDA Class 2
·Hematology
LARVAL DEBRIDEMENT THERAPY PRODUCTS - BIOBAG 50/100/200/300/400
FDA 510(k)
FDA Unclassified
·Unknown
SUPERDIMENSION INREACH SYSTEM
FDA Adverse Event
Injury
·SUPERDIMENSION INC.·Product code JAK·August 11, 2011
PARADIGM INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code LZG·September 17, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 1, 2013
SPRINT
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·June 11, 2010
i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
FDA Enforcement
Class II
·Ongoing·Abbott Point Of Care Inc.·September 24, 2025