27 results
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32ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CARTO(R) EP NAVIGATION SYSTEM, VERSION 3.0 (WITH STANDARD LOCATION PAD)
FDA 510(k)
FDA Class 2
·Cardiovascular
NATRELLE Silicone-Filled Breast Implants
FDA UDI
Allergan, Inc.·10888628002586·NATRELLE Style 120-550 High profile BIOCELL |te...
NA
FDA UDI
Summit Medical, Inc.·00385640002066·
POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-CHEM 90 CHOLESTEROL, POLY-CHEM 90 TRIGLYC
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PASSPORT 2 WITH VIEW 12 ECG ANALYSIS MODULE MODEL # 0998-00-0170-XXXX
FDA 510(k)
FDA Class 2
·Cardiovascular
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·March 16, 2021
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 16, 2025
DEPUY ASR XL FEM IMP SIZE 46
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·May 20, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 26, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 10, 2011
Natrelle and McGhan Silicone-Filled Breast Implant BioCell Round Moderate Profile, Sterile, for the following style numbers: Style 110:110-090, 110-120, 110-150, 110-180, 110-210, 110-240, 110-270, 110-300, 110-330, 110-360, 110-390, 110-420, 110-450, 110-480, 110-510; Style 115 :115-150, 115-167, 115-185, 115-203, 115-222, 115-253, 115-272, 115-290, 115-322, 115-354, 115-378, 115-401, 115-435, 115-469, 115-507, 115-547, 115-586, 115-627, 115-666, 115-716; Style 120: 120-180, 120-220, 120-260, 120-300, 120-340, 120-400, 120-440, 120-500, 120-550, 120-600, 120-650; These products may have been sold under the McGhan, Inamed or NATRELLE brands. Product Usage: Breast augmentation and Breast reconstruction
FDA Enforcement
Class I
·Ongoing·Allergan PLC·September 18, 2019
MONARCH PLATFORM
FDA Adverse Event
Malfunction
·AURIS HEALTH, INC.·Product code EOQ·January 10, 2023
A.L.P.S.CORTICAL LOCKING SCREW
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HRS·September 11, 2019
A.L.P.S.CORTICAL LOCKING SCREW
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HRS·September 11, 2019
DIST TIB ANTLAT R NRW 12H STE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSB·August 8, 2019
A.L.P.S.CORTICAL LOCKING SCREW
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HRS·August 8, 2019
A.L.P.S.CORTICAL LOCKING SCREW
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HWC·September 11, 2019
A.L.P.S.CORTICAL LOCKING SCREW
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HRS·September 11, 2019
A.L.P.S.CORTICAL LOCKING SCREW
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSB·September 11, 2019
A.L.P.S.LOW PROFILE CORTICAL SCREW
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HRS·September 11, 2019