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

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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