20 results · 23ms · Sources: EU EUDAMED, US FDA

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ClearRead CT

FDA 510(k)
FDA Class 2 ·Radiology

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772813148·GENUMEDI PRO SILVER SIZE I

Ceramco® II Silver™

FDA UDI
Dentsply International Inc.·D0011612010·

OsteoMed

FDA UDI
OSTEOMED LLC·00845694004527·0.9mm Pilot Drill, Logic Jr, OsteoPower

n/a

FDA UDI
Ortho Development Corporation·00822409070510·Snap-on Fem Augment Trial 12mm Distal Size 6

STRAIGHT ABUTMENT, 4.2, 4.6, 5.0, 6.4, IMPLANT 6.0, IMPLANT 7.0, IMPLANT 8.0 MODEL: 002061, 002062, 002063, 002064,

FDA 510(k)
FDA Class 2 ·Dental

DSNARE DIMINUTIVE POLYPECTOMY AND SUCTION SYSTEM, MODEL 00711087

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

UNKNOWN CR INSERT

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS MAHWAH·Product code JDI·July 8, 2011

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013

ACCU-CHEK COMFORT CURVE TEST STRIPS

FDA Adverse Event
Injury ·ROCHE DIAGNOSTICS·Product code LFR·September 15, 2008

TRILOGY

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code LPH·September 11, 2025

G7 VIVACIT-E

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code LPH·September 11, 2025

PRODIGY AUTOCODE

FDA Adverse Event
Injury ·OK BIOTECH CO., LTD.·Product code NBW·December 6, 2017

G7 OSSEOTI

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code LPH·September 11, 2025

TRILOGY

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code LPH·September 11, 2025

SOEHENDRA STENT RETRIEVER

FDA Adverse Event
Injury ·COOK ENDOSCOPY·Product code FGE·September 26, 2017

Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0.021), REF/Product Code RM*ES6F10HAU, STERILE, Rx ONLY

FDA Enforcement
Class II ·Terminated·Terumo Medical Corp·December 20, 2017

Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808

FDA Enforcement
Class II ·Ongoing·Philips North America·May 6, 2026

Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·December 15, 2021

Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781342 781377

FDA Enforcement
Class II ·Completed·Philips North America Llc·September 15, 2021