13 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PRIMOSPLINT SYSTEM
FDA 510(k)
FDA Unclassified
·Unknown
Hegar Dilator
FDA UDI
MEDGYN PRODUCTS, INC.·M803030832·Hegar Dilator 3-4mm
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120308321·Diamond, wheel, medium grit
Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)
FDA UDI
TENON MEDICAL, INC.·B74240308320·Slap Hammer Rod
SULZER ORTHOPEDICS ANATOMICAL SHOULDER CEMENTED HUMERAL STEM
FDA 510(k)
FDA Class 2
·Orthopedic
STEROTACTIC LOCALIZATION DEVICE (SLD)
FDA 510(k)
FDA Class 2
·Radiology
FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFTS
FDA Adverse Event
Malfunction
·ANGIOMED GMBH & CO. MEDIZINTECHNIK·Product code JCT·May 22, 2009
S5 CONSOLE FOR 4 PUMP
FDA Adverse Event
Malfunction
·SORIN GROUP DEUTSCHLAND·Product code DTQ·July 1, 2010
-BAND ACCESS PORT KIT (UNK SIZE)
FDA Adverse Event
Malfunction
·ALLERGAN·Product code LTI·March 28, 2013
TERUMO TCM II COOLING AND HEATING SYSTEM
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DWC·March 4, 2011
UNKNOWN KNEE PRODUCT
FDA Adverse Event
Other
·STRYKER ORTHOPAEDICS MAHWAH·Product code JWH·April 17, 2008
Nerve Block Tray Catalog Number: 8415
FDA Enforcement
Class II
·Terminated·Busse Hospital Disposables, Inc.·June 8, 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