21 results · 21ms · Sources: EU EUDAMED, US FDA

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DBC PRESS ACUPUNCTURE NEEDLES

FDA 510(k)
FDA Class 2 ·General Hospital

Audit MicroControls Control FD Assayed Chemistry, Level 2

FDA UDI
AALTO SCIENTIFIC·B085K0312100·

Flex

FDA UDI
Diversified Products, Inc.·00842894124710·

Cortera

FDA UDI
Xtant Medical Holdings, Inc.·00840311210015·Tap, Solid, Jacobs, 12.5

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197057622·Gross-Maier Swab Forceps curved...

RIVA Pedicle Screw System

FDA UDI
XENIX MEDICAL LLC·00840493419305·PRECONTOUR ROD, 6.0mm x 250mm

RIVA Pedicle Screw System

FDA UDI
XENIX MEDICAL LLC·00840493419213·PRECONTOUR ROD, 5.5mm x 250mm

VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS)

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

ULTRA DRIVE 6MM PLUG PULLER

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JDX·July 20, 2022

PORTEX BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE

FDA Adverse Event
Malfunction ·SMITHS MEDICAL INT'L LTD.·Product code JOH·March 5, 2013

ACCU-CHEK FLEXLINK PLUS

FDA Adverse Event
Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code FRN·March 22, 2011

INVACARE POWER WHEELCHAIR

FDA Adverse Event
Injury ·INVACARE CORPORATION - MANUFACTURING FACILITY·Product code ITI·April 18, 2008

OXFORD PARTIAL KNEE SYSTEM ANATOMIC MENISCAL BEARING ARCOM RIGHT MEDIAL

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code NRA·June 23, 2017

2710 CLEARTRACE LT

FDA Adverse Event
Other ·CONMED CORPORATION·Product code GXY·April 13, 2007

KINETRA

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·April 16, 2012

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

Spirit Plus Bed, A-C Powered Hospital Bed

FDA Enforcement
Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

Spirit Select Bed, A-C Powered Hospital Bed

FDA Enforcement
Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018