14 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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PENTAX Medical EPK-i7010 Video Processor with GI Family
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CT/MR M.A.C. Interstitial GYN Template,18G Bebig
FDA UDI
MICK RADIO NUCLEAR INSTRUMENT, INC·00817330024213·
HNM Women Care
FDA UDI
HNM STAINLESS, LLC.·00812171028154·PESSARY, DISH #5, W/O SUPPORT, 75mm
KING SEPTEMS
FDA Adverse Event
Malfunction
·KING SEPTEMS·Product code LMA·November 1, 2012
MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGY
FDA 510(k)
FDA Class 2
·Orthopedic
SFI-ANCHOR
FDA 510(k)
FDA Class 2
·Dental
IMPAX CV REPORTING
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP.·Product code LLZ·June 6, 2013
UNKNOWN 5 X 12MM SCORPIO PS INSERT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code HSH·June 23, 2011
REACH LIST DENTOTAPE 20M FROM 3 14
FDA Adverse Event
Malfunction
·JOHNSON & JOHNSON CONSUMER PRODUCTS·Product code JES·October 8, 2014
TREVO XP PROVUE 4MM X 30MM
FDA Adverse Event
Injury
·STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY·Product code NRY·July 24, 2020
BD LUER-LOK¿ SYRINGE PHARMACY CONVENIENCE TRAY, BULK, STERILE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·September 5, 2023
VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017
KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 3 / Child Silicone King LAD¿ Patient Size: 30-50kg Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012
Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics, Inc.·April 8, 2026