22 results · 23ms · 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.

6F MACH1/34356-XXX; 5F MACH1/35845-XXX; 7F MACH1/34357-XXX; 8F MACH1/34358-XXX

FDA 510(k)
FDA Class 2 ·Cardiovascular

Safco EconoPlus 3-ply bibs

FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310200283·Safco EconoPlus bib 3ply yllw 500case

A8 INTEGR8® Porous Pedicle Screw System

FDA UDI
ALLUMIN8, INC.·00850080774090·Rod Template, 5.5 mm x 300 mm

Oximeter, Fetal Pulse

FDA Pre-Market Approval
FDA Class 3 ·SERIES 50 XMO (MODEL M1350C) FETAL/MATERNAL MONITOR SYSTEM WITH INTEGRATED FETAL OXYGEN SATURATION MONITORING

ROSA®

FDA UDI
Orthosoft Inc·00889024584419·

Intelliguides

FDA UDI
Mios Marketing, LLC·G2710410200280·Anterior Closing Wedge Osteotomy Guide, 20mm x ...

Intelliguides

FDA UDI
Mios Marketing, LLC·G2710420200280·Anterior Lateral Closing Wedge Osteotomy Guide,...

RENAFLO II HF 2000 HEMOFILTER

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

BRAVO PH MONITORING SYSTEM

FDA 510(k)
FDA Class 1 ·Gastroenterology, Urology

UNKNOWN NATURAL KNEE II FEMORAL COMPONENT

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·October 6, 2020

ANEURX ABDOMINAL STENT GRAFT SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC CARDIOVASCULAR SANTA ROSA·Product code MIH·March 25, 2013

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·March 9, 2011

FREESTYLE FREEDOM

FDA Adverse Event
Injury ·ABBOTT DIABETES CARE INC, USA·Product code LFR·March 27, 2008

UNKNOWN NATURAL KNEE II TIBIAL COMPONENT

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·October 6, 2020

UNKNOWN NATURAL KNEE II FEMORAL COMPONENT

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·October 6, 2020

UNKNOWN NATURAL KNEE II ARTICULAR SURFACE

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·October 27, 2020

UNKNOWN NATURAL KNEE II FEMORAL COMPONENT

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·October 27, 2020

UNKNOWN NATURAL KNEE II TIBIAL COMPONENT

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·October 6, 2020

UNK - IMPLANT

FDA Adverse Event
Injury ·DEPUY MITEK LLC US·Product code MAI·May 23, 2023

OFFSET CUP REAMER HANDLE

FDA Adverse Event
Malfunction ·MAKO SURGICAL CORP.·Product code OLO·July 16, 2019