17 results · 22ms · 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.

Simplexa VZV Direct, Simplexa VZV Positive Control Pack

FDA 510(k)
FDA Class 2 ·Microbiology

Ophthalmic Retractor

FDA UDI
KATENA PRODUCTS, INC.·00841668101100·HELVESTON "GREAT BIG BARBIE" RETRACTOR 11MM

Marina Medical

FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306804311·Millard Double Thumb Hook (Kilner-Martinez ) Do...

PICASSO II MIS SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

POWDER FREE VINYL PATIENT EXAMINATION GLOVES

FDA 510(k)
FDA Class 1 ·General Hospital

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 19, 2025

STABLE BASE

FDA Adverse Event
Injury ·LEONHARD LANG GMBH·Product code DRX·December 10, 2019

CHROMOPHARE SURGICAL AND EXAMINATION LIGHT

FDA Adverse Event
Malfunction ·BERCHTOLD CORPORATION·Product code FSY·October 7, 2008

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011

6000CMS IOD

FDA Adverse Event
Malfunction ·MOOG DEVICE GROUP·Product code FRN·June 10, 2013

SYNFRAME RING CLAMP

FDA Adverse Event
Malfunction ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code LXH·May 9, 2018

PRODIGY AUTOCODE

FDA Adverse Event
Injury ·OK BIOTECH CO., LTD.·Product code NBW·January 23, 2020

AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-US

FDA Enforcement
Class II ·Ongoing·Fresenius Medical Care Holdings, Inc.·August 3, 2022

Allura Xper FD20/15; System Code: 722058;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

Allura Xper FD20/15; Catalog numbers: 722058

FDA Enforcement
Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025

Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024