14 results
·
22ms
·
Sources: EU EUDAMED, US FDA
SPACELABS MEDICAL MULTIPARAMETER MODULE 91496
FDA 510(k)
FDA Class 2
·Cardiovascular
LOCATOR F-Tx
FDA UDI
Zest Anchors, LLC·00840481114823·LOCATOR F-Tx Abutment for Narrow Platform (NP) ...
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481112676·LOCATOR R-Tx Abument for Narrow Platform (NP) ...
Silicone Face Mask
FDA UDI
MERCURY ENTERPRISES, INC.·10641043506059·
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481128882·LOCATOR R-Tx Abutment, NP Conical Connection, 5...
ATLAST DATA MANAGEMENT SOFTWARE (DMS)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
STACKHOUSE LENS HOOD, MODEL SA-700/F
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BD NEOFLON¿ IV CANNULA
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·March 14, 2022
ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
FDA Adverse Event
Injury
·SYNTHES USA·Product code NKB·December 29, 2015
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·April 10, 2013
SECURE 3 MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·March 15, 2011
TENDRIL ST
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·May 27, 2008
Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 26mm, B=126mm, C=96mm, D=12mm, E= 18.0f, F=.035'', G =40cm); Reorder number TFBB-26-96.
FDA Recall
Terminated
·Cook, Inc.·Product code MIH·December 20, 2004
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025