15 results · 29ms · Sources: EU EUDAMED, 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