19 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756250207·THERA-BAND® EXERCISE BAND
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197510837·RZ Tebbet Breast Retractor
150x25...
HNM Women Care
FDA UDI
HNM STAINLESS, LLC.·00812171029397·PESSARY, RING #1, W/SUPPORT, 2"
ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL 1 AND 2
FDA 510(k)
FDA Class 2
·Clinical Chemistry
NXSTAGE SYSTEM ONE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Bespa Charcot System
FDA UDI
Kapstone Manufacturing, LLC·00810041320483·Seg Column, Screw, 25
AMIA AUTOMATED PD CYCLER SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·December 15, 2020
AMIA AUTOMATED PD CYCLER SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·January 12, 2023
RINGLOC-X E1 H/W 56/32MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LPH·April 11, 2025
EMERGE?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·June 6, 2013
CATH PKGD: BERMAN 5 FR 8 0CM
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code DQO·June 22, 2011
TRI TS BASEPLATE SIZE 6
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code HSH·September 5, 2008
AMIA AUTOMATED PD CYCLER SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·February 15, 2024
Phoenix AST Indicator, Catalog Number 246004
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·March 6, 2019
TR BAND
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DXC·May 26, 2023
TR BAND
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DXC·May 26, 2023
Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025
Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025