14 results · 20ms · 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.

VALIDATE CHEM 2 CALIBRATION VERIFICATION TEST SET, MODEL 10002

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

Henry Schein

FDA UDI
HENRY SCHEIN, INC.·00304040008980·Zirlux 16+ A4 89x17x22

n/a

FDA UDI
Ortho Development Corporation·00822409072309·DAA Canal Finder (BUD)

First Aid Component - Miller & Long

FDA UDI
Certified Safety Manufacturing, Inc.·00766588121185·First Aid Component - Miller & Long

Life Instruments

FDA UDI
Life Instrument Corporation·M930701211800·Shaver 18mm

IPP INFLATABLE PENILE PROSTHESIS

FDA Adverse Event
Injury ·MENTOR UROLOGY, INC.·Product code FHW·May 2, 1997

RADIESSE DERMAL FILLER

FDA Adverse Event
Injury ·BIOFORM MEDICAL, INC.·Product code LMH·August 21, 2009

STOCKERT COMPACT SYSTEM VERSION 2.0

FDA 510(k)
FDA Class 2 ·Cardiovascular

NORMED MANDIBULAR FIXATION SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

FDA Adverse Event
Injury ·ETHICON INC.·Product code GAW·June 28, 2018

COMPLETE SE BILIARY

FDA Adverse Event
Injury ·MEDTRONIC IRELAND·Product code FGE·March 20, 2013

ACCU-CHEK SPIRIT COMBO

FDA Adverse Event
Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC·Product code LZG·March 4, 2011

GORE SEAMGUARD® BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL

FDA Adverse Event
Injury ·W.L. GORE & ASSOCIATES·Product code FTM·August 15, 2014

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012