20 results
·
37ms
·
Sources: EU EUDAMED, US FDA
MEDTRADE PRODUCT'S ANTISEPTIC BARRIER HYDROGEL DRESSINGS
FDA 510(k)
FDA Unclassified
·Unknown
BRANAN MEDICAL CORPORATION MONITECT METHAMPHETAMINE 500 DRUG SCREEN TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
RF GENERATORS, DISPOSABLE CARTRIDGE KIT, DISPOSABLE CARTRIDGE, REUSABLE HANDLE, DISOISABLE HANDPIECE REUSABLE TELESCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HEARTSTART MRX -EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 1, 2020
UNK
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code KWS·April 6, 2026
UNK
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code KWS·April 6, 2026
UNK
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code KWS·April 6, 2026
UNK
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code KWS·April 6, 2026
UNK
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code KWS·April 6, 2026
UNK
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code KWS·April 6, 2026
UNK
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code KWS·April 6, 2026
UNK
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code KWS·April 6, 2026
UNK
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code KWS·April 6, 2026
UNK
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code KWS·April 6, 2026
IMMULITE 2000
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS·Product code JJQ·March 27, 2013
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·March 17, 2011
DEEP BRAIN STIMULATION LEAD
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·April 1, 2008
OMNIPOD INSULIN PUMP
FDA Adverse Event
Injury
·INSULET CORPORATION·Product code LZG·September 29, 2022
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
cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014