19 results · 26ms · Sources: EU EUDAMED, US FDA

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NEURON MAX SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

MAXCUT CARBIDE BUR (10/pk) FG 171-L

FDA UDI
SCOTT'S DENTAL SUPPLY L.L.C.·D77811113801·MAXCUT CARBIDE BUR (10/pk) Shape: Plain Taper F...

MicroSelectron Digital

FDA UDI
Nucletron B.V.·08717213021020·PBC Quick Release Coupling Set for Gynecologica...

Sklar®

FDA UDI
SKLAR CORPORATION·10649111135354·ESMARCH HVY PLASTER SHEARS 8"

Surgical Instrument

FDA UDI
Jeil Medical Corporation·08800089431069·

Summa Orthopaedics System Surgical Instrument

FDA UDI
Jeil Medical Corporation·08800089466405·

MODIFICATION TO THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

RXPEAKFLOW

FDA 510(k)
FDA Class 2 ·Anesthesiology

PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code MGB·May 14, 2013

ACCU-CHEK ® MOBILE TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·September 23, 2014

ASR ACETABULAR CUPS 54

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

BD ANGIOCATH¿ PLUS 22 G X 1 IN.

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·November 8, 2017

MEDFUSION 3500 SYRINGE INFUSION PUMP

FDA Adverse Event
Malfunction ·ST PAUL·Product code FRN·July 9, 2022

TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD

FDA Adverse Event
Injury ·ETHICON INC.·Product code OTN·April 30, 2021

TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD

FDA Adverse Event
Injury ·ETHICON INC.·Product code OTN·April 30, 2021

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

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

CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

Model Number L131, ESSENTIO DR EL MRI Pacemaker

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