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