118 results · 30ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

STERISPINE LC CAGE

FDA 510(k)
FDA Class 2 ·Orthopedic

Ophthalmic Speculum

FDA UDI
KATENA PRODUCTS, INC.·00841668100233·LIEBERMAN ASPIRATING SPECULUM V-WIRE

MaxFuse,VBR, 12 (D) x 14 (W) x 34 (H)

FDA UDI
Pioneer Surgical Technology, Inc.·00846468056308·12 (D) x 14 (W) x 34 (H)

TSC

FDA 510(k)
FDA Unclassified ·Unknown

MODIFICATION TO:TRABECULAR METAL FEMORAL CONE AUGMENTS, MODELS 03-125-ZZZZ

FDA 510(k)
FDA Class 2 ·Orthopedic

IDENTITY ADX XL DR

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, INC, CRMD·Product code LWP·January 13, 2014

VITATRON DA+ C-SERIES DR

FDA Adverse Event
Injury ·IPG MFG SWITZERLAND·Product code DXY·June 7, 2013

TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·July 6, 2011

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·June 13, 2025

BD LUER-LOK DISPOSABLE SYRINGE WITH BD LUER-LOK TIP

FDA Adverse Event
Malfunction ·BECTON DICKINSON DE MEXICO·Product code FMF·February 22, 2019

BD LUER-LOK DISPOSABLE SYRINGE WITH BD LUER-LOK TIP

FDA Adverse Event
Malfunction ·BECTON DICKINSON DE MEXICO·Product code FMF·February 22, 2019

BD LUER-LOK DISPOSABLE SYRINGE WITH BD LUER-LOK TIP

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·February 25, 2021

3 ML BD LUER-LOK LUER-LOK TIP

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FMF·June 3, 2019

3 ML BD LUER-LOK LUER-LOK TIP

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·July 1, 2019

SYRINGE 3ML LL 200 S/C

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FMF·July 29, 2021

BD 10ML SYRINGE LUER-LOK TIP

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·June 28, 2019

3 ML BD LUER-LOK LUER-LOK TIP

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FMF·March 15, 2019

SYRINGE 3ML LL 200 S/C

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FMF·January 23, 2021

3 ML BD LUER-LOK LUER-LOK TIP

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FMF·August 7, 2019

Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model Numbers: GIF-1TH190, GIF-1TQ160, GIF-2T160, GIF-2TH180, GIF-H170, GIF-H180, GIF-H180J, GIF-H190, GIF-HQ190, GIF-LV1, GIF-N180, GIF-Q150, GIF-Q160Z, GIF-Q180, GIF-XP180N, GIF-XP190N, GIF-XTQ160. 510(k) Numbers: K112680, K954451, K051645, K100584, K111756, K011151, K123317.

FDA Enforcement
Class II ·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023