20 results
·
28ms
·
Sources: EU EUDAMED, US FDA
GIVEN DIAGNOSTIC SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Cetro America Ultrasound Transducer for Fetacare, Kranzbüler, Waterproof
FDA UDI
CETRO AMERICA INC·00852519007144·Replacement Waterproof Ultrasound Transducer fo...
Bierer Angled 5x6 Teeth Economy
FDA UDI
MEDGYN PRODUCTS, INC.·M803031033·Bierer Angled 5x6 Teeth Economy 9" (229mm)
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776171759·BIERER TENAC FORCEPS CURVED SERRATED
10 x 33mm Citrelock ACL Implant
FDA UDI
Acuitive Technologies, Inc.·00810027270665·
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0310030·Probe, 1.5 inch Ball, Steffee, Curved, Black
10 x 28mm Citrelock ACL Implant
FDA UDI
Acuitive Technologies, Inc.·00810027270658·
NA
FDA UDI
STRYKER CORPORATION·07613154479061·Intra-Oral Blade (11.5 x 0.38 x 5.0mm)
DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132
FDA 510(k)
FDA Class 2
·Clinical Toxicology
AGILITY STEERABLE GUIDEWIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
SEE H10
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code NBC·April 18, 2013
CS300
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·March 28, 2013
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Injury
·ANIMAS CORP.·Product code LZG·March 16, 2011
GE OEC 2600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS, INC·Product code JAA·April 17, 2008
ARROW RA CATH KIT: 20 GA X 1-1/2" (3.81 CM)
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC.·Product code DQX·November 17, 2021
ARROW ACCESS TRAY
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL LLC·Product code DQX·February 21, 2022
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