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

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5.5 / 6.5MM SPARTAN PEEK SURTURE IMPLANT WITH #2 MAGNUMWIRE / WITH NEEDLES, EXTRACTION TOOL, 5.5 / 6.5MM PUNCH TAP

FDA 510(k)
FDA Class 2 ·Orthopedic

LuxaPost

FDA UDI
DMG Chemisch-Pharmazeutische Fabrik GmbH·EDMG1107810·Glass fiber-reinforced pre-silanized composite ...

JOBST Men's Dress

FDA UDI
BSN MEDICAL, INC.·00035664107819·MEN'S DRESS 8-15 MM HG KNEE HIGH CLOSED TOE MED...

Marina Medical

FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306818295·AXS Table Clamp- Rotatable, Aluminum

3M ESPE HAUR

FDA 510(k)
FDA Class 2 ·Dental

OBSIDIAN CERAMIC BLOCKS

FDA 510(k)
FDA Class 2 ·Dental

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·March 13, 2026

ACTIVA

FDA Adverse Event
Malfunction ·IPG MFG SWITZERLAND·Product code MHY·October 4, 2016

BD LUER SLIP¿ TUBERCULIN SYRINGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMF·February 8, 2018

TOSHIBA Kalare Diagnostic X-Ray System K110785

FDA Recall
Terminated ·Toshiba American Medical Systems Inc·Product code JAA·April 3, 2013

STERLING?

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·May 14, 2013

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 23, 2014

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 1, 2011

TOSHIBA Kalare Diagnostic X-Ray System K110785

FDA Enforcement
Class II ·Terminated·Toshiba American Medical Systems Inc·July 17, 2013

SYRINGE 5ML LL TIP BULK CONVENIENCE PAK

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FMF·January 27, 2021

BD BBL GC-Lect Agar; Cat. No. 297715 The device is a selective medium providing enhanced growth and recovery of Neisseria gonorrhoeae and better inhibition of contamination bacteria and fungi.

FDA Enforcement
Class II ·Terminated·Becton Dickinson & Co.·August 29, 2018

BD BBL GC-Lect Agar; Cat. No. 297715 The device is a selective medium providing enhanced growth and recovery of Neisseria gonorrhoeae and better inhibition of contamination bacteria and fungi.

FDA Recall
Terminated ·Becton Dickinson & Co. 7 Loveton Cir BD Diagnostic Systems·Product code JTY·June 21, 2018

Video Duodenoscope

FDA Enforcement
Class II ·Terminated·Pentax Medical Company·June 8, 2016

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