18 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CENTRICITY PACS WEB DIAGNOSTIC
FDA 510(k)
FDA Class 2
·Radiology
OsteoMed
FDA UDI
OSTEOMED LLC·00845694008655·3.0mm x 18mm Lag Screw
Non-Locking Screw, 2.7mm x 18mm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665026313·
OsteoMed
FDA UDI
OSTEOMED LLC·00845694035231·3.0 x 18mm Lag Screw, Sterile
NA
FDA UDI
Hangzhou AGS MedTech Co., Ltd.·06959664925584·
OsteoMed
FDA UDI
OSTEOMED LLC·00845694067508·3.0 x 18mm Lag Screw Sterile Qty 5
TITAN TIBIAL NAIL
FDA 510(k)
FDA Class 2
·Orthopedic
REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTITIVE TEST KIT
FDA 510(k)
FDA Class 2
·Immunology
FisherBrand Model 12 Centrifuge, DASH Apex 12
FDA UDI
DRUCKER DIAGNOSTICS·00810052860145·General purpose laboratory centrifuge for sampl...
NA
FDA UDI
Hangzhou AGS MedTech Co., Ltd.·06959664928943·
BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·February 18, 2022
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·April 29, 2013
ENTERRA
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LNQ·May 5, 2011
HARMONIC ACE 36CM W ERG HANDLE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code LFL·July 23, 2008
Stryker, REF: 0250070460, 5.0 mm x 32 cm, Strykeprobe, Outer Sheath Replacement, RX Only, Non-Sterile, CE, UDI: (01) 07613327051971 These products are distributed with the following sheath/probe: 0250070441-PKG, StrykeFlow Electrocautery Probe, Spatula Tip 5MM 0250070442-PKG, StrykeFlow Electrocautery Probe, J Tip, 5MM 0250070443-PKG, StrykeFlow Electrocautery Probe, L Tip, 5MM 0250070444-PKG, StrykeFlow Electrocautery Probe, Ball Tip, 5MM 0250070445-PKG, StrykeFlow Electrocautery Probe, Needle Tip 5MM 0250070446-PKG, StrykeFlow Electrocautery Probe, Spoon Tip, 5MM
FDA Enforcement
Class II
·Terminated·Stryker Corporation·March 25, 2020
OPAQUE Herrick Lacrimal Plugs, HP3, 0.3 mm, HP5, 0.5mm, HP7, 0.7.mm, STERILE, EO, Rx only, CE Dry eye treatment
FDA Enforcement
Class II
·Ongoing·Lacrimedics Inc·March 9, 2022
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 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