29 results · 27ms · 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.

CLICKFINE PEN NEEDLE

FDA 510(k)
FDA Class 2 ·General Hospital

Ackermann

FDA UDI
Preat Corporation·00842092107478·Ackermann BL Clip SS

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04064984699427·GENUMEDI SILVER SIZE VIII

Corneal Trephine

FDA UDI
KATENA PRODUCTS, INC.·00841668112779·BARRON VACUUM PUNCH 8.0MM

Explorer TO

FDA UDI
Seaspine Orthopedics Corporation·10889981289270·8mm Trial, 11mm Height

VISICOIL MR

FDA UDI
Izi Medical Products, LLC·B887SNMR05001021080·0.5mm x 1cm Platinum Fiducial Marker Pre-Loaded...

NIAGARA® Lateral Access System

FDA UDI
VB Spine LLC·10888857519992·Straight Blade, Size 20x120 mm

MEDPOR COATED TEAR DRAIN

FDA 510(k)
FDA Unclassified ·Unknown

AMEDICA DRUG TEST THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MDMA, OXY, TCA

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

GLIDESHEATH SLENDER NITINOL (CONVENIENCE KIT)

FDA Adverse Event
Malfunction ·TERUMO MEDICAL CORPORATION·Product code DYB·February 21, 2018

NORIAN REINFORCED FAST SET PUTTY/3CC

FDA Adverse Event
Malfunction ·SYNTHES SELZACH·Product code GXP·May 19, 2015

ZIMMER KINECTIV MODULAR NECK

FDA Adverse Event
Injury ·ZIMMER, INC.·Product code KWA·April 26, 2013

XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code NIQ·September 19, 2014

9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 19, 2011

HAHN TAPERED IMPLANT 4.3 X 11.5

FDA Adverse Event
Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·June 15, 2022

GLIDESHEATH SLENDER NITINOL (CONVENIENCE KIT)

FDA Adverse Event
Malfunction ·TERUMO MEDICAL CORPORATION·Product code DYB·December 16, 2019

SSS Reprocessed Zimmer, Synthes, Stryker and Linvatec Drill Bits and Blades Surgical drill bits, blades, burs, chisels, rasps, taps and reamers are specially designed surgical accessories to help the surgeon cut and drill bone and bony structures. Reprocessed surgical accessories are indicated for use in patients requiring surgery involving bone and bony structures.

FDA Enforcement
Class II ·Terminated·Stryker Sustainability Solutions·November 18, 2015

Software: Syngo.via RT Image Suite software version VA30_SP02 with license T_RT_IMAGE_SUITE_PAT_MARK Intended Use: used as an advanced application on a SOM10 scanner SMN: 10496180

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 30, 2020

syngo.via RT Image Suite with syngo.via VB30, VB40, VB50 and VB60- Intended for Radiation Therapy Treatment Material Number: 10496180

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc·September 22, 2021

Syngo.via and Syngo.x ; a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·June 10, 2015