13 results
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22ms
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Sources: EU EUDAMED, US FDA
MAXI CAMERA 37
FDA 510(k)
FDA Class 1
·Radiology
Mini-Taurus
FDA UDI
Rmo, Inc.·00885797100733·ALEX MT 022 HK/2,3 5-5 20EA
Symmetry WILLIAMS
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482031322·Symmetry® Retractor, Williams Microlumbar, 70 m...
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209132447·
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776098186·Spinal Discectomy Retractor
AUTO SUTURE ENDO CLIP 5MM
FDA Adverse Event
Malfunction
·UNITED STATES SURGICAL CORP.·Product code GCJ·March 12, 1998
MDI MII ONE-PIECE IMPLANT, 2.9MM
FDA 510(k)
FDA Class 2
·Dental
XIA SPINE SYSTEM SACRAL BLOCK ASSEMBLY
FDA 510(k)
FDA Class 2
·Orthopedic
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 9, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 23, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC., USA·Product code LFR·September 27, 2007
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 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