13 results
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19ms
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Sources: EU EUDAMED, US FDA
CLINETICS PCA COLUMN
FDA 510(k)
FDA Class 2
·Immunology
N/A
FDA UDI
GEORGE TIEMANN & CO.·B58208013060·INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
NUPRO® Prophylaxis Paste with Fluoride
FDA UDI
DENTSPLY INTERNATIONAL INC.·D0038013061·NUPRO® Prophy Paste, Cookie Dough, Coarse, Sing...
Oph.Forceps
FDA UDI
KATENA PRODUCTS, INC.·00841668117804·0.06mm Canaloplasty Forceps, Short Hdl
InFix®
FDA UDI
ZIMMER SPINE, INC.·00889024331099·
SP DYNAMIS, SP SPECTRO, XS DYNAMIS, XS SPECTRO, XP DYNAMIS, XP SPECTRO, MODELS M021-4AF/3, M002-2A
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
STETHOS, MODEL STXXYYZZ OR 001 XXX, STETHOS LINK, MODEL SLXXYYZZ OR 002 XXX
FDA 510(k)
FDA Class 2
·Cardiovascular
HAMILTON-C3
FDA Adverse Event
Malfunction
·HAMILTON MEDICAL AG·Product code CBK·February 9, 2024
UNIFY CRT-D, DF-4 CONNECTOR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·May 8, 2014
L-BONE PLATE, MP, 4 HOLE, LEFT, SHORT
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS FREIBURG·Product code JEY·October 17, 2012
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·May 28, 2015
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