18 results
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27ms
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Sources: EU EUDAMED, US FDA
PARAMAX ALANINE AMINOTRANSFERASE REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
NA
FDA UDI
Smith & Nephew, Inc.·03596010591982·SOD GUIDE TIBIAL OFFSET STEPPED
Map-iT
FDA UDI
ACCESS POINT TECHNOLOGIES, INC.·00818083010966·Fixed, 6 electrode, HIS, 2-5-2mm electrode spacing
Welch Allyn, Inc.
FDA UDI
WELCH ALLYN, INC.·00732094318340·UTK MODULE - 2
GRADIA®
FDA UDI
Gc America Inc.·D0479011051·GRADIA PLUS Paste LB-Inlay TD, 2ml 1pc
Welch Allyn, Inc.
FDA UDI
WELCH ALLYN, INC.·00732094318913·RADIO CARD NEWMAR 380 PROVISIONED
RP One-Piece Standard Abutment 5.5mm Cuff
FDA UDI
STERNGOLD DENTAL LLC·00841549107078·RP One-Piece Standard Abutments attach directly...
TUBE SHAFT INSULATED
FDA UDI
SONTEC INSTRUMENTS, INC.·B09929011050·TUBE SHAFT INSULATED WITHOUT LUER LOCK
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515227040·Spratt Mastoid Curette, sz 2/0
Miracle Suction FULL Kit
FDA UDI
DiaDent Group International·08806383524414·Multifunctional Mirror with Suction
Elite® Bondable Buccal Tubes
FDA UDI
Ortho Organizers, Inc.·00190707070823·Elite®.022 U6R TBT/HK DB
POWDER-FREE, NATURAL COLOR, LATEX EXAMINATION GLOVE MODEL: MEPF1
FDA 510(k)
FDA Class 1
·General Hospital
MOSS MIAMI 6.35MM ROD SYSTEM PEDICLE AND LAMINAR HOOKS
FDA 510(k)
FDA Class 2
·Orthopedic
QUADRA ASSURA CRT-D, DF-4 CONNECTOR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·June 30, 2014
MONARC SLING SYSTEM
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code OTN·January 3, 2013
TOTALCARE BARIATRIC
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·November 10, 2010
SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE
FDA Adverse Event
Malfunction
·SYNCARDIA SYSTEMS, INC.·Product code LOZ·October 24, 2014
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