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

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PRIMADO SURGICAL DRILL

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

RMO

FDA UDI
Rmo, Inc.·00885797100122·REMOV QUADHELIX KIT

General Instrument

FDA UDI
ALPHATEC SPINE, INC.·00840180504703·2x10mm Left Angled Pituitary w/ Scissor Style H...

5 ML BD LUER-LOK SYRINGE STERILE, SINGLE USE

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·August 10, 2020

UNIPOLAR NEEDLES

FDA 510(k)
FDA Class 2 ·Anesthesiology

PROLENE (POLYPROPYLENE) 3D PATCH, NONABSORBABLE SYNTHETIC SURGICAL MESH

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

Biliary Plastic Stent Set

FDA UDI
Micro-Tech (Nanjing) Co., Ltd.·06932503514033·TPU,Side bend,8.5Fr,7cm working length with 220...

Biliary Plastic Stent Set/ short-wire compatible

FDA UDI
Micro-Tech (Nanjing) Co., Ltd.·06932503515153·TPU, Double pigtails,8.5Fr,7cm working length w...

Biliary Plastic Stent Set

FDA UDI
Micro-Tech (Nanjing) Co., Ltd.·06932503514521·TPU, Double pigtails,8.5Fr,7cm working length w...

Biliary Plastic Stent Set

FDA UDI
Micro-Tech (Nanjing) Co., Ltd.·06932503515641·TPU,Straight,8.5Fr,7cm working length with 2200...

Biliary Plastic Stent Set

FDA UDI
Micro-Tech (Nanjing) Co., Ltd.·06932503514279·TPU,Center bend,8.5Fr,7cm working length with 2...

Biliary Plastic Stent Set/ short-wire compatible

FDA UDI
Micro-Tech (Nanjing) Co., Ltd.·06932503514965·TPU,Center bend,8.5Fr,7cm working length with 2...

Biliary Plastic Stent Set/ short-wire compatible

FDA UDI
Micro-Tech (Nanjing) Co., Ltd.·06932503514781·TPU,Side bend,8.5Fr,7cm working length with 220...

5" (13 CM) BAG SPIKE ADAPTER W/SPIROS® W/RED CAP, VENTED CAP

FDA Adverse Event
Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code ONB·December 24, 2019

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·June 23, 2025

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 26, 2013

ITREL 3

FDA Adverse Event
Death ·MDT PUERTO RICO OPERATIONS CO, MED REL·Product code LGW·July 23, 2008

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·May 6, 2011

EVOLUT FX PLUS VALVE

FDA Adverse Event
Malfunction ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·June 23, 2025

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