19 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AEQUALIS REVERSED FRACTURE SHOULDER PROTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
PMMA disc
FDA UDI
Dentsply International Inc.·D00180821200·
KING Snap Lead/DIN Connector
FDA UDI
Kego Corporation·00663427000109·KING Snap Lead/DIN Connector Qty 5
3.0 m (120")...
VALIDATE CHEM 4 CALIBRATION VERIFICATION TEST SET, MODEL 10004
FDA 510(k)
FDA Class 1
·Clinical Chemistry
LIQUICHEK BLOOD GAS CONTROL, MODEL 571, 572, 573
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MALLINCKRODT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TYCOHEALTHCARE·Product code JOH·November 18, 2010
MALLINCKRODT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TYCOHEALTHCARE·Product code BTR·December 9, 2010
MALLINCKRODT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TYCOHEALTHCARE·Product code BTR·February 1, 2011
PAXGENE® BLOOD RNA TUBE
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code NTW·May 1, 2026
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 29, 2013
ADJUSTABLE PIN COLLET
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code GET·April 26, 2011
LIFEPAK 20 DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code LDD·July 25, 2008
UNSPECIFIED BD PAXGENE® BLOOD TUBE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code PJE·June 13, 2025
PAXGENE® BLOOD RNA TUBE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code NTW·March 23, 2026
PAXGENE® BLOOD RNA TUBE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code NTW·March 31, 2026
PAXGENE® BLOOD RNA TUBE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code NTW·February 9, 2026
Aqauapak 728 SW, 760 ML W/028 Adaptor, Intl, Product No. 403728; Aqauapak 1028 SW, 1070 ML/W028 Adaptor, Intl, Product No. 404128; Aqauapak 428 SW, 440 ML W/028 Adaptor, Intl, Product No. 404428; Aquapak 728 SW, 760 ML W/028 Adaptor, Product No. 037-28; Aquapak SW/EAU Sterile, 760 ML W/Adaptor, Product No. 037-28C; Aquapak 728 SW, 760 ML W/28 Adaptor, French, Product No. 037-02F; Aquapak 733 SW, 760 ML W/033 Adaptor, Product No. 037-33; Aquapak 735 HNS, 760 ML W/028 Adaptor, Product No. 037-35; Aquapak 739 FNS, 760 ML W/028 Adaptor, Product No. 037-39; Aquapak 0.9% NACL, 760 ML W/Adaptor, Product No. 037-39C; Aquapak 770 HNS, 760 ML W/033 Adaptor, Product No. 037-70; Aquapak 1028 SW, 1070 ML W/028 Adaptor, Product No. 041-28; Aquapak SW/EAU Sterile, 1070 ML W/Adaptor, Product No. 041-28C; Aquapak 1033 SW, 1070 ML W/033 Adaptor; Product No. 041-33; Aquapak 1035 HNS, 1070 ML W/028 Adaptor, Product Code 041-35; Aquapak 428 SW, 440 ML W/028 Adaptor, Product No. 044-28; Aquapak SW/EAU Sterile, 440 MLW/Adaptor, Product No. 044-28C; Aquapak 428 SW, 440 ML W/028 Adaptor, French, Product No. 044-28F; Aquapak 433 SW, 440 ML W/033 Adaptor, Product No. 044-33; Aquapak 435 HNS, 440 ML W/028 Adaptor, Product No. 044-35; Aquapak 470 HNS, 440 ML W/033 Adaptor, Product No. 044-70. Used in anesthesiology.
FDA Enforcement
Class II
·Terminated·Teleflex Medical·December 10, 2014
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