19 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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MODIFIED AUTO SUTURE PURSTRING DISP. AUTOMATIC
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ANGIOMAT ILLUMENA
FDA Adverse Event
Malfunction
·LIEBEL-FLARSHEIM·Product code IZQ·June 7, 2017
NA
FDA UDI
Smith & Nephew, Inc.·00885554008487·SOD CANN OPRTV 5.5MM 0DEG EXT
Map-iT
FDA UDI
ACCESS POINT TECHNOLOGIES, INC.·00818083010980·Fixed, 6 electrode, MPB, 2mm electrode spacing
X PRO DISPOSABLE TIP
FDA UDI
PaloDEx Group Oy·06430035872954·X PRO DISPOSABLE TIP, INTEGRATED BOX OF 25 TIPS
GRADIA®
FDA UDI
Gc America Inc.·D0479011071·GRADIA PLUS ONE BODY LB-B, 2.0ml 1pc
TUBE SHAFT INSULATED
FDA UDI
SONTEC INSTRUMENTS, INC.·B09929011070·TUBE SHAFT INSULATED WITHOUT LUER LOCK
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515227057·Spratt Mastoid Curette, sz 1/0
HALO MOLAR BAND
FDA UDI
Ortho Arch Company Inc·D90990110715·U6R HALO MOLAR BAND .022 SGL CV -10T BT
Elite® Bondable Buccal Tubes
FDA UDI
Ortho Organizers, Inc.·00190707070847·Elite®.022 U6R SING/HK DB
Elite® Bondable Buccal Tubes
FDA UDI
Ortho Organizers, Inc.·00190707070854·Elite®.022 U6R SING/HK DB (5)
FRESENIUS COMBILINES LOW VOLUME BLOOD TUBING SET, MODELS 03-2291 (POST PUMP) AND 03-2292 (PRE-PUMP)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MODEL P8400 HEMOSTATIX THERMAL SCALPEL SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Cosmopor silicone 10x8cm P10
FDA UDI
PAUL HARTMANN AG·04052199572345·Cosmopor silicone 10x8cm P10
UPHOLD? LITE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code OTP·June 30, 2014
MONARC SLING SYSTEM
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code OTN·January 3, 2013
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FPO·November 10, 2010
BD¿ BLUNT FILL NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code GAA·May 1, 2019
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