11 results · 25ms · 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.

K-PACK II NEEDLE - 27G X 3/4 THIN WALL

FDA 510(k)
FDA Class 2 ·General Hospital

MSI Precision Specialty Instruments

FDA UDI
Med Saver, Inc.·00194613070212·Metzenbaum Scissors, TC, Straight, Fine, Blunt ...

COMPREHENSIVE LOCKING SCREW

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code HWC·July 5, 2019

MEDLEY PCA MODULE, MODEL 8120

FDA 510(k)
FDA Class 2 ·General Hospital

BOVIE J-PLASMA HANDPIECE WITH RETRACTABLE CUTTING BLADE

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

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·May 29, 2025

SELUTE PICOTIP

FDA Adverse Event
Malfunction ·GUIDANT PUERTO RICO BV·Product code NVY·October 1, 2014

LAG SCREW, TI GAMMA3 Ø10.5X95MM

FDA Adverse Event
Malfunction ·STRYKER TRAUMA KIEL·Product code HSB·May 29, 2013

ENDO GIA UNIVERSAL 12MM SINGLE USE INST

FDA Adverse Event
Injury ·UNITED STATES SURGICAL·Product code GDW·June 14, 2011

Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.

FDA Enforcement
Class I ·Terminated·Dexcom Inc·April 20, 2016

Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Ingenuity Core, Ingenuity Core 128, Ingenuity CT 728321 - Ingenuity Core 728323 - Ingenuity Core 128 728326/728327 - Ingenuity CT

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·July 7, 2021