16 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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INTERMEZZO IMPLANT SYSTEMS
FDA 510(k)
FDA Class 2
·Dental
N/A
FDA UDI
GEORGE TIEMANN & CO.·B5821051018·HOOK, SURGICAL, GENERAL & PLASTIC SURGERY
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00510181·
MicroAire®
FDA UDI
Microaire Surgical Instruments LLC·00847399004970·SST TWIST DRILL, DENTAL, 1.8mm Dia. x 49mm
LATERAL DISTAL FIBULA PLATE, XL, 18-HOLE, LEFT
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665029178·
TAUT BALLOON CATHETER, MODEL 50640
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MICROSCAN MICROSTREP PLUS PANEL - CHLORAMPHENICOL
FDA 510(k)
FDA Class 2
·Microbiology
REUSABLE INFANT Y-PIECE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZO·February 21, 2007
Diatech Diamond Instruments
FDA UDI
Coltène/Whaledent AG·J006200059DD0·
Diatech Diamond Instruments
FDA UDI
Coltène/Whaledent AG·J006200058DD0·
SPINEMED TABLE - FDA 510(K) K051013
FDA Adverse Event
Other
·CERT HEALTH SCIENCES, LLC·Product code ITH·July 16, 2007
SPRINT FIDELIS
FDA Adverse Event
Malfunction
·MPRI·Product code LWS·April 10, 2013
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·UNKNOWN MANUFACTURING FACILITY·Product code FRN·April 12, 2011
IDENTITY DR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·May 27, 2008
HEALICOIL RG SA 5.5MM W/3 UB-BL CB BL BK- Absorbable Suture anchor Product Number: 72203707
FDA Enforcement
Class II
·Ongoing·Smith & Nephew, Inc.·October 28, 2020
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