16 results · 21ms · Sources: EU EUDAMED, US FDA

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NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

n/a

FDA UDI
HANS RUDOLPH, INC.·00874750006649·1410A 2W NRBV W/MP SALIVA TRAP

SIMPLEABI

FDA 510(k)
FDA Class 2 ·Radiology

GYNECARE TENSION-FREE VAGINAL TAPE SYSTEM

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

BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO.·Product code JKA·May 1, 2018

LINEAR 7.5 FR. 25CC IAB

FDA Adverse Event
Malfunction ·DATASCOPE CORP. - FAIRFIELD·Product code DSP·October 17, 2019

LINEAR 7.5 FR. 25CC IAB

FDA Adverse Event
Malfunction ·DATASCOPE CORP. - FAIRFIELD·Product code DSP·October 17, 2019

UNKNOWN_RECONSTRUCTIVE_PRODUCT

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·May 14, 2013

UNKNOWN DEPUY ASR CUP

FDA Adverse Event
Injury ·DEPUY INTL. LTD.·Product code KWA·May 19, 2011

LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 LARGE TITANIUM LIGATING CL

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code FZP·August 11, 2008

SENSATION PLUS 7.5FR. 40CC IAB

FDA Adverse Event
Malfunction ·DATASCOPE CORP. - FAIRFIELD·Product code DSP·February 23, 2021

SENSATION PLUS 7.5FR. 40CC IAB

FDA Adverse Event
Malfunction ·DATASCOPE CORP. - FAIRFIELD·Product code DSP·January 4, 2022

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

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

BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·December 15, 2021