20 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CATHETER INTRODUCER
FDA 510(k)
FDA Class 2
·Cardiovascular
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·H65810435251·Acclean Prophy Paste Coarse
SureLOK Mini Posterior Cervical/Upper Thoracic System
FDA UDI
PRECISION SPINE, INC.·00840019907125·3.5mm x 25mm SureLOK™ PC Screw
VOLUSON 730 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
CONTREET-H ANTIMICROBIAL HYDROCOLLOID DRESSING, MODELS 9610 (4 X 4 (10 CM X 10CM), 9613 (6X6 (15CM X 15CM)
FDA 510(k)
FDA Unclassified
·Unknown
SYSTEM 98XT, ENGLISH, 110V
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·February 3, 2026
EVIS EXERA III BRONCHOVIDEOSCOPE
FDA Adverse Event
Injury
·AIZU OLYMPUS CO., LTD.·Product code EOQ·May 19, 2023
SYSTEM 98XT
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·September 22, 2025
IBP ELB INT. ULNA LRG RGT LNG STM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JDC·June 24, 2016
ASSY,ENGLISH,DOMSTC,110V,SYS98
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·December 26, 2025
CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·November 3, 2025
CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·November 18, 2025
MAXCEM ELITE
FDA Adverse Event
Injury
·KERR CORPORATION·Product code EMA·April 9, 2013
ISERT ASPHERIC INTRAOCULAR LENS
FDA Adverse Event
Malfunction
·HOYA SURGICAL OPTICS INC.·Product code HQL·February 25, 2011
CONTAK RENEWAL 4
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code NIK·May 8, 2008
CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·January 14, 2026
ASSY,ENGLISH,DOMSTC,110V,SYS98
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·September 15, 2025
SENSATION 7FR. 34CC IAB
FDA Adverse Event
Death
·DATASCOPE CORP. - FAIRFIELD·Product code DSP·February 2, 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
Panda iRes Infant Radiant Warmer. Device sold under the following product names: Panda iRes Warmer and Panda iRes Bedded Warmer.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·November 28, 2018