22 results · 30ms · Sources: EU EUDAMED, US FDA

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HydroCision SpineJet System

FDA 510(k)
FDA Class 2 ·Orthopedic

MAYO STILLE SCISSORS

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896083851·MAYO STILLE SCISSORS STRAIGHT ROUND BLADES POWE...

Orthoquest

FDA UDI
Young Innovations, Inc.·00843471159095·Niti Thermal Tri-Force Nat Dimp 020X020 Up

BSSO TRANSORAL PLATNG DRILL RETRACTOR

FDA UDI
W.H. Holden, Inc.·D9282007290·

NLITE SYSTEM,MODEL A00-1051

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

ARROW ULTRA 8 INTRA-AORTIC BALLOON CATHETERS (IABS) 8FR 30CC AND 40CC UNIVERSAL

FDA 510(k)
FDA Class 2 ·Cardiovascular

AUVON TENS & EMS DEVICE

FDA Adverse Event
Injury ·SHEN ZHEN AS TEC TECHNOLOGY CO LTD·Product code NUH·January 28, 2025

2.4MM X 8MM BONE MANIPULATION SCREW

FDA Adverse Event
Malfunction ·OSTEOMED, LLC·Product code HWC·September 22, 2025

DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

FDA Adverse Event
Injury ·BAXTER HEALTHCARE CORPORATION·Product code KDI·October 24, 2014

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

OBTRYX SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 1, 2013

PATIENT INTERFACE NIM4CPB1 NIM 4.0

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·October 28, 2025

AUVON TENS UNIT

FDA Adverse Event
Injury ·SHEN ZHEN AS TEC TECHNOLOGY CO LTD·Product code NUH·December 19, 2024

STIMULATOR, ELECTRICAL, EVOKED RESPONSE

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·July 31, 2023

NIM 4.0 CONSOLE

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·September 5, 2025

NIM 4.0 CONSOLE

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·August 2, 2024

NIM 4.0 CONSOLE

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·May 20, 2025

The Leica ASP6025 Tissue Processor. Pathology and Hematology Departments. The Leica ASP6025 Tissue Processor is an automated system used to process tissue specimens for examination through fixation, dehydration and infiltration.

FDA Enforcement
Class II ·Terminated·Leica Microsystems, Inc.·September 30, 2015

BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 200 MM, Silicone, Sterile, Item 431199.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020

MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

FDA Enforcement
Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024