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