19 results
·
29ms
·
Sources: EU EUDAMED, US FDA
AUTO-SAFETY INJECTOR-2 (ASI-2)
FDA 510(k)
FDA Class 2
·General Hospital
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
CMF CUSTOMIZED IMPLANT KIT LARGE
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS-MAHWAH·Product code KKY·March 7, 2013
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·November 7, 2019
PASS LP
FDA Adverse Event
Injury
·MEDICREA INTL.·Product code MNI·September 16, 2011
APASS LP
FDA Adverse Event
Other
·MEDICREA INTERNATIONAL·Product code MNI·June 15, 2011
PASS LP
FDA Adverse Event
Injury
·MEDICREA INTERNATIONAL·Product code MNI·July 12, 2013
PASS LP
FDA Adverse Event
MEDICREA TECHNOLOGIES·Product code MNI·April 17, 2013
PASS LP
FDA Adverse Event
Injury
·MEDICREA INTERNATIONAL·Product code MNI·November 11, 2011
PASS LP
FDA Adverse Event
Injury
·MEDICREA INTERNATIONAL·Product code MNI·April 5, 2012
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 29, 2013
WIRE COLLET
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code HWE·April 27, 2011
SOFTCLIX PLUS LANCET DEVICE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·July 23, 2008
PASS LP
FDA Adverse Event
Injury
·MEDICREA TECHNOLOGIES·Product code MNI·April 17, 2013
PASS LP
FDA Adverse Event
Injury
·MEDICREA INTERNATIONAL·Product code MNI·July 12, 2013
PASS LP - LIAPASS
FDA Adverse Event
Injury
·MEDICREA TECHNOLOGIES·Product code MNI·March 29, 2013
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 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