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

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IS4000 8mm Harmonic ACE Curved Shears

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

MAXIM® VI KNEE SYSTEM

FDA UDI
Biomet Orthopedics, LLC·00887868225826·

MAXIM VI KNEE SYSTEM

FDA UDI
Biomet Orthopedics, LLC·00880304205758·

Dropper Urine Chemistry Control Level 1 Set 3x25mL

FDA UDI
QUANTIMETRIX CORPORATION·00896863002202·The Dropper Urine Chemistry Control is intended...

FRESHKONALLURING EYES, FRESHKON COLORS FUSION, FRESHKONCOLORS FUSION SPARKLERS, FRESHKON MOSAIC, FRESHKON GLITZI

FDA 510(k)
FDA Class 2 ·Ophthalmic

UNIVERSAL XACTTRACE

FDA 510(k)
FDA Class 2 ·Anesthesiology

PS FEMORAL COMPONENT CLOSED BOX LGE RIGHT 74 MM CEMENTED

FDA Adverse Event
Malfunction ·BIOMET SPAIN, S.L.·Product code JWH·June 3, 2020

AMISTEM H FEMORAL STEMS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·December 24, 2025

TM MONOBLOCK TIBIA

FDA Adverse Event
Injury ·ZIMMER TMT·Product code JWH·May 29, 2013

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 6, 2014

HYDRATOME RX SPHINCTEROTOME

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code KNS·June 28, 2011

PERF CON TIB BRG LRG 22X60

FDA Adverse Event
Injury ·BIOMET SPAIN, S.L.·Product code KRR·August 13, 2020

NON-POROUS PERF TIB TRAY-LGE

FDA Adverse Event
Injury ·BIOMET SPAIN, S.L.·Product code KRR·August 13, 2020

PERF ANAT TIBIAL STEM 120X14X5

FDA Adverse Event
Injury ·BIOMET SPAIN, S.L.·Product code KRR·August 13, 2020

PKG, METZENBAUM SCISSORS, CURVED LONG, P/N 0250080265. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

FDA Enforcement
Class II ·Terminated·Stryker Endoscopy·December 24, 2014