17 results · 42ms · Sources: EU EUDAMED, US FDA

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KERR GEL ETCHANT

FDA 510(k)
FDA Class 2 ·Dental

Implant Prosthetics

FDA UDI
Preat Corporation·00842092127339·ASC NobelActive™/Conical-compatible RP Screw

PowerPICC Provena

FDA UDI
Bard Access Systems, Inc.·00801741200915·Catheter Placement Kit

ALGO 5

FDA UDI
Natus Medical Denmark ApS·05713315012181·PRINTER WITH DUALLOCK / PAPER

GentleYAG

FDA UDI
Candela Corporation·00817495020327·Pulsed Laser

MINIMED SILHOUETTE

FDA Adverse Event
Injury ·UNOMEDICAL UM-D·Product code FPA·February 9, 2025

FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING WITH COLLAGEN

FDA 510(k)
FDA Unclassified ·Unknown

ELIACHAR LARYNGEAL FOAM STENT, MODEL ELL-1

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·January 2, 2026

TUFF IMPLANT

FDA Adverse Event
Injury ·NORIS MEDICAL LTD·Product code DZE·September 15, 2024

OT ULTRALINK METER

FDA Adverse Event
Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 13, 2013

HAKIM PROG VALVE INLINE SIPHONGUARD

FDA Adverse Event
Injury ·CODMAN & SHURTLEFF, INC., MEDOS S.A.·Product code JXG·February 18, 2011

SILICONE ADVANCED OPTIC LENS

FDA Adverse Event
Injury ·BAUSCH & LOMB·Product code HQL·February 20, 2008

UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Enforcement
Class II ·Ongoing·B-K Medical A/S·November 12, 2025

ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.

FDA Enforcement
Class II ·Terminated·Spacelabs Healthcare, Llc·February 5, 2014

Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

FDA Enforcement
Class II ·Ongoing·Covidien·August 28, 2024