19 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.

ALMA LASERS MODIFIED DIODE LASER MODULE WITH SHR TREATMENT MODE FOR USE WITH THE FAMILY OF SOPRANO XL MULTI-APPLICATION

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

MSI Precision Specialty Instruments

FDA UDI
Med Saver, Inc.·00194613017699·K-Wire, Double Ended, Trocar Point, Diameter Si...

Connector Holding Forceps

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215068479·

PENTA

FDA Adverse Event
Injury ·GUIDANT VASCULAR INTERVENTION·Product code MAF·January 25, 2002

CASPIAN Spinal System

FDA UDI
VB Spine LLC·10888857242159·Distractor

GALAXY LITE

FDA 510(k)
FDA Class 1 ·Physical Medicine

MODIFICATION TO THERMAL ANGEL

FDA 510(k)
FDA Class 2 ·Hematology

WAVEWRITER ALPHA PRIME 16

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 29, 2024

PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

FDA Adverse Event
Malfunction ·SYNTHES MONUMENT·Product code KWI·January 25, 2017

CONSTELLATION VISION SYSTEM

FDA Adverse Event
Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·May 7, 2013

XIENCE PRO EVEROLIMUS ELUTING RX CORONARY STENT SYSTEM

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code NIQ·September 23, 2014

CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code DYE·June 2, 2011

8MM TI STRAIGHT RADIAL STEM 28MM-STERILE

FDA Adverse Event
Injury ·SYNTHES MONUMENT·Product code KWI·January 24, 2017

22MM COCR RADIAL HEAD STANDARD HEIGHT/12.5MM-STERILE

FDA Adverse Event
Injury ·SYNTHES MONUMENT·Product code KWI·January 24, 2017

18MM COCR RADIAL HEAD STANDARD HEIGHT/11.5MM-STERILE

FDA Adverse Event
Injury ·SYNTHES MONUMENT·Product code KWI·September 7, 2017

7MM TI STRAIGHT RADIAL STEM 26MM-STERILE

FDA Adverse Event
Injury ·SYNTHES MONUMENT·Product code KWI·September 7, 2017

SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670 & 11061678 SOMATOM X.cite 11330001 Intended Use: Computed tomography x-ray system

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

Model Number L131, ESSENTIO DR EL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025