20 results
·
22ms
·
Sources: EU EUDAMED, US FDA
AUTO-BAND LIGATOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014609829·MAQUET 5.25" DELUXE GEL
AUDIO TECHNOLOGIES S:R.1
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
AQUARIUS WORKSTATION
FDA 510(k)
FDA Class 2
·Radiology
ENDOPATH THORACIC ENDO LINEAR CUTTER W/SAFETY LOCK
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code GAG·June 16, 1997
NDEHP PRIMARY PLUM PREPIERCED Y
FDA Adverse Event
Malfunction
·HOSPIRA HOLDINGS DE COSTA RICA LTD.·Product code FRN·April 25, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·April 26, 2013
KINMTC ROT HINGE SHRT TIB BEAR
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code LGE·September 11, 2014
INFINITI VISION SYSTEM
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·April 14, 2011
ENDOPATH THORACIC ENDO LINEAR CUTTER W/SAFETY LOCK
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code GAG·December 31, 1997
SKINVIVE BY JUVEDERM XC 2X1 ML
FDA Adverse Event
Injury
·ALLERGAN (PRINGY)·Product code LMH·May 8, 2024
ENDOPATH THORACIC ENDO LINEAR CUTTER W/SAFETY LOCK
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code GAG·January 7, 1998
ENDOPATH THORACIC ENDO LINEAR CUTTER W/SAFETY LOCK
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code GAG·December 23, 1997
ENDOPATH THORACIC ENDO LINEAR CUTTER W/SAFETY LOCK
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code GAG·December 23, 1997
Femoral Nail, A/R T2 Femur ¿10x320 mm, Product Number 18251032S
FDA Enforcement
Class II
·Terminated·Stryker GmbH·July 18, 2018
ENDOPATH THORACIC ENDO LINEAR CUTTER W/SAFETY LOCK
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code GAG·August 12, 1997
ENDOPATH THORACIC ENDO LINEAR CUTTER W/SAFETY LOCK
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, INC.·Product code GAG·October 9, 1997
Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·February 28, 2018
Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use Part Number: 08763662001
FDA Enforcement
Class II
·Ongoing·Roche Diagnostics Operations, Inc.·January 6, 2021
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