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

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

MYRIAN

FDA 510(k)
FDA Class 2 ·Radiology

SCFE Screw

FDA UDI
ORTHOPEDIATRICS CORP.·00841132116463·7.0MM BONE SCREW WASHER

Key Surgical Indicator Dot Case Locking Tags

FDA UDI
KEY SURGICAL, INC.·00849771031031·Case Locking Tag, Orange, Steam Indicator Dot. ...

JOBST Elvarex

FDA UDI
BSN-Jobst GmbH·04019702542646·Elvarex Forte 3/Knee High/Profile-Slant-Closed ...

JOBST Elvarex

FDA UDI
BSN-Jobst GmbH·04019702519235·Elvarex 3/Chap Style/Closed Toe, E-Version, Kne...

JOBST Elvarex

FDA UDI
BSN-Jobst GmbH·04019702407662·Elvarex 2/Knee High/Slant-Open Toe/Dotted 5 cm ...

Immunalysis

FDA UDI
IMMUNALYSIS CORP·00840937105160·Opiates Antibody Analyte Specific Reagent (ASR)

TRAM 2001 MODULE

FDA 510(k)
FDA Class 2 ·Cardiovascular

SHANGHAI GLOVMAX ENTERPRISE POWDERED BLUE NITRILE EXAMINATION GLOVES

FDA 510(k)
FDA Class 1 ·General Hospital

LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

FDA Adverse Event
Injury ·COOK VASCULAR INC·Product code DRE·September 8, 2015

SYRINGE 50ML LL BNS

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FMF·April 10, 2024

CPS SHORT ANCHOR PLUG 10MM

FDA Adverse Event
Injury ·.·Product code JWH·May 13, 2019

CPS TRANSVERSE PIN 6PK 32MM

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JDI·May 13, 2019

BD SYRINGE LUER-LOK¿ TIP

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·September 20, 2023

LOCKING RECONSTRUCTION PLATE AXSOS 14 HOLE / L222MM 5.0MM LOCKING SET

FDA Adverse Event
Injury ·STRYKER OSTEOSYNTHESIS-SELZACH·Product code HRS·April 22, 2013

ANGIOSEAL

FDA Adverse Event
ST. JUDE MEDICAL, INC·Product code MGB·April 25, 2011

GE OEC 2800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEM INC.·Product code JAA·July 10, 2008

LEAD EXTRACTION EVOLUTION SHORTIE RL CONTROLLED-ROTATION DILATOR SHEATH SET

FDA Adverse Event
Injury ·COOK VASCULAR INC·Product code DRE·September 9, 2015

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001699;

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

Auxiliary Common Gas Outlet (ACGO) conversion/install kits sold under product names CONV KIT SCGO TO ACGO and ACGO ASSY FIELD INSTL. These kits are not affected specifically, however are included due to being purchased with or later used to convert to ACGO.

FDA Enforcement
Class I ·Ongoing·Datex-Ohmeda, Inc.·October 30, 2024