18 results · 36ms · Sources: EU EUDAMED, US FDA

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NuVasive® CoRoent® Small Interlock™ System

FDA 510(k)
FDA Class 2 ·Orthopedic

Kyocera Medical Technologies, Inc.

FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523138142·Trial, 42 X 32, 19mm Height 22° Hyperlordotic

Kyocera Medical Technologies, Inc.

FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523138159·Trial, 42 X 32, 21mm Height 22° Hyperlordotic

Kyocera Medical Technologies, Inc.

FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523138128·Trial, 42 X 32, 15mm Height 22° Hyperlordotic

Kyocera Medical Technologies, Inc.

FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523138135·Trial, 42 X 32, 17mm Height 22° Hyperlordotic

PULSE OXIMETER, MODEL PM-50

FDA 510(k)
FDA Class 2 ·Cardiovascular

V-LOC 180 ABSORBABLE RELOAD, V-LOC PBT NON-ABSORBABLE RELOAD, ENDO STITCH (TM) ENDOSCOPIC SUTURING DEVICE, SILS (TM)...

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·June 24, 2025

COBAS 6000 E601 MODULE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LJK·August 8, 2011

COBAS 6000 E601 MODULE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LJK·October 4, 2011

PENTA

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 5, 2013

LIFEVEST WCD 4000 SYSTEM

FDA Adverse Event
Malfunction ·ZOLL MANUFACTURING CORPORATION·Product code MVK·July 23, 2014

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·July 14, 2011

FMsealer Open Shears. Model FM3001

FDA Enforcement
Class II ·Terminated·Domain Surgical, Inc.·December 7, 2016

UNKNOWN VLOC PRODUCT

FDA Adverse Event
Injury ·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015

UNKNOWN VLOC PRODUCT

FDA Adverse Event
Injury ·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015

UNKNOWN VLOC PRODUCT

FDA Adverse Event
Injury ·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015

X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222, AB6224, AB6318, AB6320, AB6322, AB6324, AB6418, AB6420, AB6422, AB6424, AB6522, AB6524, AB6A18, AB6A20, AB6A22, AB6A24, AB6C18, AB6C20, AB6C22, and AB6C24.

FDA Enforcement
Class II ·Ongoing·Coloplast Manufacturing US, LLC·January 22, 2025