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

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NOVATION CROWN CUP LINERS; NEUTRAL, LIPPED, +5MM LATERALIZED, +5/10 DEGREE

FDA 510(k)
FDA Class 2 ·Orthopedic

NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JDI·September 5, 2024

NV GXL LINER LIPPED 32MM ID, GROUP 1 CUPS

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JDI·September 5, 2024

ALT HA S CLR EXT

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code MEH·November 14, 2023

NV GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JDI·May 31, 2024

NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JDI·August 12, 2024

BIOLOX DELTA FEMORAL HEAD 32MM OD, -3.5MM

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JDI·October 3, 2024

NV GXL LINER LIPPED 36MM ID GROUP 2

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JDI·November 1, 2022

UniTip High Resolution Catheter

FDA UDI
Unisensor AG·07640172973714·

WOOJEON ACUPUNCTURE NEEDLE (=SERA ACUPUNCTURE NEEDLE)

FDA 510(k)
FDA Class 2 ·General Hospital

NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350D

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

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

CONFIRM

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, CRMD·Product code MXC·January 13, 2014

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 20, 2013

LCS R BRDG BRG STD+/LG 10.0

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code NJL·June 1, 2011

XIA TITANIUM 4.5 BLOCKER

FDA Adverse Event
Malfunction ·STRYKER SPINE-US·Product code NKB·September 3, 2020

GMK-REVISION, FEMUR REVISION PS #5 R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·January 8, 2016

Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor

FDA Enforcement
Class II ·Terminated·Senseonics, Inc.·November 6, 2019

Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

FDA Enforcement
Class II ·Terminated·Ecolab Inc·September 30, 2015

cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018