21 results · 25ms · Sources: EU EUDAMED, US FDA

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E.G. SCAN II ESPHAGOSCOPE SYSTEM

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

Marina Medical

FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306819889·Deep Deaver Retractor 3in wide 7in w/Doyen Handle

NA

FDA UDI
Summit Medical, Inc.·00385640002103·

O'REGAN DISPOSABLE ANOSCOPE

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

STARTROL LED LIGHTING SYSTEMS (X=# OF PODS, Y=# OF LEDS, N=TO MOUNTING STYLE) MODEL X X Y -N-S-W. X=NUMBER OF LIGHT PODS

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

SCISSORS INSERT CEV605G 3PK 350MM

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INSTRUMENTATION S.A.S. LE PAVILLON·Product code GEI·August 29, 2013

SCISSORS INSERT CEV605G 3PK 350MM

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INSTRUMENTATION S.A.S. LE PAVILLON·Product code GEI·August 29, 2013

VENTED AUTOFEED CHAMBER

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·April 4, 2013

ELECSYS ANTI-HBS II

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LOM·February 18, 2025

MINICAP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·May 20, 2013

VASOVIEW HEMOPRO

FDA Adverse Event
Malfunction ·MAQUET CARDIOVASCULAR LLC·Product code GEI·August 21, 2014

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 10, 2011

ADULT INSPIRATORY HEATED BREATHING CIRCUIT

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·November 21, 2012

Titanium Tack Starter Kit, REF 400-270, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.

FDA Enforcement
Class II ·Terminated·BioHorizons Implant Systems Inc·December 26, 2012

UNKDELTAFILL

FDA Adverse Event
Malfunction ·REFER TO SECTION H10·Product code KRD·October 9, 2018

UNKDELTAFILL

FDA Adverse Event
Malfunction ·REFER TO SECTION H10·Product code KRD·October 9, 2018

UNKDELTAFILL

FDA Adverse Event
Malfunction ·REFER TO SECTION H10·Product code KRD·October 9, 2018

TUBE CEV649-5B DIA 5MM 350MM [MXI/XOM]

FDA Adverse Event
Injury ·XOMED MICROFRANCE ENGINEERING·Product code GEI·October 18, 2013

FORCEPS CEV134 BIPOLAR 350MM MOUIEL

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INSTRUMENTATION S.A.S.·Product code GEI·August 29, 2013

Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format)  Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.)  Track interproximal decay progression over time  Patient education tool

FDA Enforcement
Class II ·Terminated·GA Industries·May 6, 2015