26 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Groshong NXT PICC Catheter
FDA 510(k)
FDA Class 2
·General Hospital
7600 V MASK
FDA UDI
HANS RUDOLPH, INC.·00874750001378·DIAPH/AAV PORT SUB ASSY 7600
16PW - Washington Gas - Poly White
FDA UDI
Certified Safety Manufacturing, Inc.·00766588014425·16PW - Washington Gas - Poly White
Ionto Plus Butterfly
FDA UDI
COMPASS HEALTH BRANDS CORP.·00092237901748·Iontophoresis Drug Delivery Butterfly Electrode...
Ionto Plus Butterfly, Box of 12
FDA UDI
COMPASS HEALTH BRANDS CORP.·10853904006008·Iontophoresis Drug Delivery Electrodes
Richmar
FDA UDI
South Dakota Partners Inc.·00850030915283·Richmar Butterfly Ionto Electrode, Box of 12
CAPINTEC CRC 55T SERIES DOSE CALIBRATORS, MODELS CRC 55TR, CRC 55TPET AND CRC 55TW
FDA 510(k)
FDA Class 2
·Radiology
STERILE SENSICARE ADVANTIX POWDER FREE POLYURETHANE MEDICAL/DENTAL EXAMINATION GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
SPRINT
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code LWS·December 9, 2015
BHR
FDA Adverse Event
Injury
·SMITH & NEPHEW ORTHOPAEDICS LTD., U.K.·Product code KWY·October 13, 2008
2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 26, 2013
MINICAP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - GUANGZHOU·Product code KDI·August 11, 2011
PHYSIOMESH UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code FTL·April 5, 2019
SECURESTRAP UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GDW·April 5, 2019
NAVISTAR® THERMOCOOL®
FDA Adverse Event
Injury
·BIOSENSE WEBSTER, INC. (IRWINDALE)·Product code LPB·April 6, 2017
MAQUET Servo Humidifier 163, Inmed Mfg. Sdn. Bhd. Lot PT 2577, Jalan Perusahaan, 4, 34600 Kamunting, Perak, Malaysia.
FDA Enforcement
Class II
·Terminated·Teleflex Medical·September 7, 2016
Servo Humidifier 163, Model 01-06-8125-8, REF 6419365 Product Usage: A heat and moisture condenser (artifical nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the trachea) to warm and humidity gases breathed in by the patient.
FDA Enforcement
Class II
·Terminated·Teleflex Medical·August 17, 2016
HOLDING SLEEVE-STANDARD WITH STOP FOR MATRIX
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code LXH·March 29, 2016
HOLDING SLEEVE-STANDARD WITH STOP FOR MATRIX
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code LXH·March 29, 2016
UNK - CONSTRUCTS: PFNA
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HSB·December 26, 2019