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

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Charisma

FDA 510(k)
FDA Class 2 ·Dental

X-CORE

FDA UDI
Nuvasive, Inc.·00887517424266·X-CORE 2 Ti Core, Ø16x30-49mm

OsteoMed

FDA UDI
OSTEOMED LLC·00845694018920·Swivel Screwdriver Handle

Hayden Medical

FDA UDI
Hayden Medical, Inc.·00840319705285·Masson (Mayo-Hegar) Needle Holder 10-1/2" (26.3...

Medallion®

FDA UDI
Merit Medical Systems, Inc.·00884450052785·

BPR Medical

FDA UDI
BPR MEDICAL LIMITED·05060274504364·Microdial Flowmeter - Range A 0.02 - 3 l/min - ...

Coaxial needle

FDA UDI
Möller Medical GmbH·04260277177881·

REUSABLE LINEAR STAPLER HANDLE

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

REPROCESSED COMPRESSION SLEEVES

FDA 510(k)
FDA Class 2 ·Cardiovascular

GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/10 MM LEFT

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·October 27, 2016

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·June 23, 2025

PENUMBRA MAX PUMP - INDIGO SYSTEM

FDA Adverse Event
Malfunction ·PENUMBRA INC., USA·Product code NRY·August 23, 2018

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON

GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/10 MM LEFT

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·April 21, 2017

PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER

FDA Adverse Event
Malfunction ·PENUMBRA, INC.·Product code NRY·March 8, 2018

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·Stellarex 0.035 OTW Drug-coated Angioplasty Balloon

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·Stellarex 0.035 OTW Drug-Coated Angioplasty Balloon

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·Stellarex 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·Stellarex 0.035 OTW Drug-coated Angioplasty Ballon

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·Stellarex™ 0.035” OTW Drug-coated Angioplasty Balloon