19 results · 29ms · 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.

EQUINOXE UHMWPE 12* POSTERIOR AUGMENT PEGGED GLENOID, SMALL / MEDIUM / LARGE / EXTRA-LARGE, LEFT / RIGHT

FDA 510(k)
FDA Class 2 ·Orthopedic

MAXCUT CARBIDE BUR (10/pk) FG 171

FDA UDI
SCOTT'S DENTAL SUPPLY L.L.C.·D77811113791·MAXCUT CARBIDE BUR (10/pk) Shape: Plain Taper F...

MicroSelectron Digital

FDA UDI
Nucletron B.V.·08717213021013·Quick Release Coupling Set for Needles and Flex...

SYNGO.VIA WEB VIEWER

FDA 510(k)
FDA Class 2 ·Radiology

AIR-N-GO

FDA 510(k)
FDA Class 1 ·Dental

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·May 8, 2025

MONOSYN VIOLET 5/0 (1) 70CM HR17 (M)

FDA Adverse Event
Malfunction ·B.BRAUN SURGICAL SA·Product code GAM·December 11, 2019

ASR UNI FEMORAL IMPL SIZE 47

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 13, 2011

TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·May 14, 2013

LEAD, UNKNOWN

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·September 23, 2014

MONOSYN VIOLET 6/0 (0.7) 70CM HR13 (M)

FDA Adverse Event
Malfunction ·B.BRAUN SURGICAL SA·Product code GAM·December 11, 2019

Y-KNOT FLEX 1.3MM ALL-SUTURE ANCHOR WITH ONE NO. 2 WHITE/BLUE HI-FI SUTURE

FDA Adverse Event
Malfunction ·CONMED CORPORATION·Product code MBI·April 23, 2019

PREMILENE 3/0 (2) 75CM DS24 (M)

FDA Adverse Event
Malfunction ·B.BRAUN SURGICAL SA·Product code GAW·December 11, 2019

MONOSYN VIOLET 5/0 (1) 70CM HR17 (M)

FDA Adverse Event
Malfunction ·B.BRAUN SURGICAL SA·Product code GAM·December 11, 2019

SOMATOM go.Now (Model #11061620), with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning. This CT system can be used for low dose lung cancer screening in high risk populations. High risk populations are as defined by professional medical societies.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 10, 2019

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

Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis

FDA Enforcement
Class II ·Terminated·Synthes, Inc.·July 22, 2015

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