14 results · 21ms · 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.

ASAP SINUSCOPE 10-0036-00,10-0037-00,10-0038,10-0039-00,10-0040-00,10-0041-00,10-0042-00,10-0043-00,10-0044-00,10-0045-0

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

Baltic Denture System BD Load

FDA UDI
Merz Dental GmbH·D7091032822·Baltic Denture System BDLoad Mm6 PLSEbim6DFm A3...

MODIFICIATION TO: BILIARY WALLSTENT ENDOPROSTHEIS WITH MONORAIL DELIVERY SYSTEM, MODEL 71-XXX

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

VERTEX SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

NONE - SEE PHYSICIAN COMMENTS IN H10.

FDA Adverse Event
Injury ·Product code JWH·October 16, 2013

ELEVATED RIM LINER 36 MM I.D. SIZE KK FOR USE WITH 56 MM O.D. SIZE KK SHELL

FDA Adverse Event
Injury ·ZIMMER, INC.·Product code KWZ·September 16, 2016

SYNGO RT THERAPIST CONNECT WORKSPACE, V4.2

FDA Adverse Event
SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code IYE·April 3, 2013

COLLEAGUE CXE VOLUMETRICINFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·March 29, 2011

PUMP MMT-515LNAB PRDGM INS V2.1 BL EN

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code LZG·April 21, 2008

Iradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set - Syringe Adapter Set, REF 1057-50,

FDA Enforcement
Class II ·Ongoing·Iradimed Corporation·April 5, 2023

Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-1406S, SPI 08-11 and b) REF 1806-1407S, SPI 08-13. Product Usage: The T2 Tibial Nailing system is intended to provide temporary stabilization of various types of fractures, malunion and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compressed locked. The system is indicated for long bone fracture fixation, specifically tibial fracture fixation. The sleeves are intended to ease nail insertion and to protect the condyle surfaces during nail insertion.

FDA Enforcement
Class II ·Terminated·Stryker Howmedica Osteonics Corp.·October 22, 2014

HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL-- Absorbable Suture anchor Product Number: 72203704

FDA Enforcement
Class II ·Ongoing·Smith & Nephew, Inc.·October 28, 2020

Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018