15 results · 24ms · 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.

PriMatrix Dermal Repair Scaffold

FDA 510(k)
FDA Unclassified ·Unknown

Ophthalmic Speculum

FDA UDI
KATENA PRODUCTS, INC.·00841668100608·KATENA DOUBLE-X SPECULUM K-WIRE SMALL

Ophthalmic Speculum

FDA UDI
KATENA PRODUCTS, INC.·00841668100349·FEMTO SPECULUM FLAT WIRE

CAPNOSTREAM20P WITH HIFI C02 MONITORING

FDA 510(k)
FDA Class 2 ·Anesthesiology

GE LOGIQ I, LOGIQ E AND VIVID E

FDA 510(k)
FDA Class 2 ·Radiology

CART 9733856 S7 STAFF ASSEMBLED 110V

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·June 18, 2019

CART 9733856 S7 STAFF ASSEMBLED 110V

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·June 6, 2019

STEALTHSTATION S7 SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code HAW·February 12, 2018

CART 9734056 S7 STAFF SHRT 100-120V INTL

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·June 18, 2019

STEALTHSTATION® S7

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·March 18, 2019

FLOGARD

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 8, 2013

LIGAMAX-5MM

FDA Adverse Event
Injury ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·July 7, 2011

GE OEC 9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 11, 2008

ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

FDA Enforcement
Class II ·Ongoing·Elekta, Inc.·December 13, 2023

BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020