17 results · 23ms · Sources: EU EUDAMED, US FDA

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SHERLOCK TLS STYLET, SHERLOCK TLS DETECTOR

FDA 510(k)
FDA Class 2 ·General Hospital

Allied Medical LLC

FDA UDI
Allied Medical, LLC·00026072000540·Demand Valve.

Kyocera Medical Technologies, Inc.

FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523107919·Straight Rod 6.0mm diameter 240mm CoCr

Kyocera Medical Technologies, Inc.

FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523107087·Straight Rod 6.0mm diameter 240mm length Ti6Al4V

Kyocera Medical Technologies, Inc.

FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523107674·Straight Rod 6.0mm diameter 240mm length CP Tit...

BIOMET EXTERNAL WRIST PLATE

FDA 510(k)
FDA Class 2 ·Orthopedic

ST AIA-PACK CA 19-9

FDA 510(k)
FDA Class 2 ·Immunology

E SERIES DEFIBRILLATOR

FDA Adverse Event
Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·February 26, 2013

PINN MAR NEUT 32IDX54OD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·September 5, 2014

L9000 LIGHTSOURCE

FDA Adverse Event
Malfunction ·STRYKER ENDOSCOPY SAN JOSE·Product code FCW·April 11, 2011

TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT

FDA Adverse Event
Death ·BOSTON SCIENTIFIC CORP.·Product code NIQ·April 17, 2006

TAXUS EXPRESS2 PACLITAXEL ELUTING STENT

FDA Adverse Event
Death ·BOSTON SCIENTIFIC CORPORATION·Product code NIQ·April 17, 2006

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001691;

FDA Enforcement
Class II ·Ongoing·Beaver Visitec International, Inc.·September 4, 2024

KYPHON KURVE BONE FILLER DEVICE 13GA

FDA Adverse Event
Malfunction ·MEDTRONIC MEXICO·Product code KIH·July 14, 2020

TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT

FDA Adverse Event
Death ·BOSTON SCIENTIFIC CORP.·Product code NIQ·April 17, 2006

BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 200 MM, Silicone, Sterile, Item 431197.

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

CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

FDA Enforcement
Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015