22 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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VersaWrap
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DOUBLE-J
FDA UDI
Gyrus ACMI, LLC·00821925006393·7.0FR(2.3mm)X 12 cm SURGITEK DOUBLE-J CLOSED TI...
JMS A.V.FISTULA NEEDLE SET (SINGLE TYPE)
FDA UDI
JMS SINGAPORE PTE LTD·08888483005185·A.V.FISTULA 16GX1" BE 15CM W/CLAMP (SINGLE TYPE)
6PW - CPRotector® TWO Economy - Poly White
FDA UDI
Certified Safety Manufacturing, Inc.·00766588030005·6PW - CPRotector® TWO Economy - Poly White
Ophthalmic Hooks
FDA UDI
KATENA PRODUCTS, INC.·00841668114292·SINSKEY IOL HOOK STR (BX/3)
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113769·AIR INJECT CANNULA 30GA
PORTABLE X-RAY SYSTEM
FDA 510(k)
FDA Class 2
·Dental
Sentinel
FDA 510(k)
FDA Class 2
·Radiology
ASKU
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·November 26, 2025
CLEARLINK CONTINU-FLO SOLUTION SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·July 22, 2023
CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·May 24, 2022
CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·May 4, 2022
CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·January 24, 2022
SILICONE ADVANCED OPTIC-VIOLET SHIELD
FDA Adverse Event
Malfunction
·BAUSCH & LOMB·Product code HQL·October 16, 2008
ATTAIN ABILITY PLUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code OJX·August 11, 2011
NAVIFLEX? RX DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code FGE·July 3, 2013
CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·March 14, 2022
FIRST STEP SELECT
FDA Adverse Event
Malfunction
·ARJOHUNTLEIGH, INC.·Product code FNM·August 10, 2016
Moore Hip Prosthesis Long Fenestrated Stem, several head Diameter, 203 mm Stem length. Used to seat the prosthesis with or without bone cement.
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·August 28, 2013
ATAR Reusable Extension Cable, sold under brand names: ATAR Reusable Series, ATAR 53912 Reusable Series, and XI Reusable Series. Model codes: 53912 - MDTS ATAR REUSABLE, 53912A - MDTS ATAR REUSABLE, ATAR MDTS REUSABLE, ATAR-A DARK BLUE REUSABLE, ATAR-MDT REUSABLE, ATAR-MDT2 REUSABLE, ATAR-MDT2S-A, DK BLUE 30CM REUSABLE, ATAR-MDT2S-V WHITE 30CM REUSABLE, ATAR-MDTL REUSABLE, ATAR-MDTR REUSABLE, ATAR-R REUSABLE, ATAR-R T4P REUSABLE, ATAR-R1 REUSABLE, ATAR-RL REUSABLE, ATAR-T REUSABLE, ATAR-V WHITE REUSABLE, ATAR-V2 REUSABLE, XI.A DARK BLUE REUSABLE, XI.MDT REUSABLE, XI.R REUSABLE, XI.V WHITE, REUSEABLE Cable is intended to connect an electrode/lead from a patients or another cable to a diagnostic machine or an external pacemaker
FDA Enforcement
Class I
·Terminated·Oscor, Inc.·July 19, 2017