22 results · 22ms · 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.

UCP Stem

FDA 510(k)
FDA Class 2 ·Orthopedic

XENMATRIX

FDA UDI
Davol Inc.·00801741129018·XenMatrix AB Surgical Graft, 25 cm x 30 cm

LEONE SPA

FDA UDI
LEONE SPA·08033707014485·CALIBRA 1ST MOL BANDS W/G8325-02 n.UR 30

Ophthalmic Forceps

FDA UDI
KATENA PRODUCTS, INC.·00841668106327·CASTROVIEJO FORCEPS 0.9MM

Endo-Model Knee System - Instruments

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575305599·Orthopaedic implant aiming/guiding block, reusa...

Endo-Model Knee System - Instruments

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575245246·Orthopaedic implant aiming/guiding block, reusa...

Best Medical International

FDA UDI
BEST MEDICAL INTERNATIONAL, INC.·00841365119767·

Best Medical International

FDA UDI
BEST MEDICAL INTERNATIONAL, INC.·00841365121272·

Endo-Model Knee System - Instruments

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575245253·Orthopaedic implant aiming/guiding block, reusa...

3DI INCLUDING CSCORE

FDA 510(k)
FDA Class 2 ·Radiology

SEEDNET, SEEDNET GOLD, CRYOHIT, CRYOTHERA

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

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·June 27, 2024

ZINGER GUIDE WIRE - CRDM

FDA Adverse Event
Injury ·MEDTORNIC, INC·Product code DQX·June 7, 2013

S-ICD SYSTEM

FDA Adverse Event
Injury ·CAMERON HEALTH·Product code NVY·August 11, 2014

STENOSCOP

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 27, 2011

HANDPIECE MICS

FDA Adverse Event
Malfunction ·MAKO SURGICAL CORP.·Product code OLO·May 23, 2018

Link Patella Glide Resection Guide- For the implantation of the Endo-Model Knee System as part of a total knee arthroplasty procedure. Product Code: 15-2530/05

FDA Recall
Open, Classified ·Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany·Product code FZX·November 30, 2023

Link Patella Glide Resection Guide- For the implantation of the Endo-Model Knee System as part of a total knee arthroplasty procedure. Product Code: 15-2530/05

FDA Enforcement
Class II ·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·January 24, 2024

Precise Treatment Table. To be used as part of radiation therapy treatment process.

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·April 17, 2013

All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·March 12, 2014