15 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Atlas SPEEDER Head/Neck
FDA 510(k)
FDA Class 2
·Radiology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814534·GENUMEDI SAND SIZE II
Tying Forceps
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896102620·Castroviejo Tying Forceps Tungsten Carbide Dust...
H & L FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL168H, HL168J & HL168Q
FDA 510(k)
FDA Class 2
·Cardiovascular
INTEGRA ELECTRODE TUNNELING NEEDLE
FDA 510(k)
FDA Class 2
·Neurology
IMP,TSV,4.1MM,DUAL SEL,HA
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·February 5, 2024
IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·February 5, 2024
PNEUMO SURE XL HIGH FLOW INSUFFLATOR
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY SAN JOSE·Product code HIF·June 20, 2011
BRILLIANCE 64
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.·Product code JAK·May 30, 2013
HEARTSTART FRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·September 30, 2014
4.0MM TI LOCKING SCREW W/T25 STARDRIVE 32MM FOR IM NAILS
FDA Adverse Event
Injury
·SYNTHES MEZZOVICO·Product code HSB·February 19, 2017
REAL INTELLIGENCE ROBOTIC DRILL GUARD
FDA Adverse Event
Malfunction
·BLUE BELT TECHNOLOGIES·Product code OLO·July 20, 2025
Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium
FDA Enforcement
Class II
·Terminated·Exactech, Inc.·November 25, 2020
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026