21 results
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21ms
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Sources: EU EUDAMED, US FDA
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