25 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
STERITEC AUTOCLAVE TAPES, MODEL CI122 & CI1234
FDA 510(k)
FDA Class 2
·General Hospital
ODYSSEY®
FDA UDI
Microport Orthopedics Inc.·M684K00616491·
TruForm
FDA UDI
Rmo, Inc.·00885797099693·MAN MLR BDS ASST 100 SE ASIA
AP 24® Smile Pop Toothbrush
FDA UDI
NSE PRODUCTS, INC.·00850021097578·
artVeneer life
FDA UDI
Merz Dental GmbH·D7092001649·artVeneer life lower anteriors, UCS, BL4
Thuvera
FDA UDI
IPG Medical Corporation·00810071230097·Thuvera, Flat Tip, Reusable Laser Fiber, 365um
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
FDA 510(k)
FDA Class 2
·Hematology
GUTHRIE POWDER-FREE LATEX SURGICAL GLOVE WITH (50 MICROGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
HEARTSTART
FDA Adverse Event
Malfunction
·PHILIPS NORTH AMERICA LLC·Product code NSA·July 11, 2025
LOCKING SCREWDRIVER BODY
FDA Adverse Event
Malfunction
·DEPUY FRANCE SAS - 3003895575·Product code HXX·November 8, 2019
SYSTEM, PERITONEAL AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·March 13, 2013
WEB-BASED DATA MANAGEMENT
FDA Adverse Event
Injury
·MEDTORNIC MINIMED·Product code MDS·February 18, 2011
MODULAR MICROPLASTY CUP INSERTER 1/4"-28 THREAD INSERT
FDA Adverse Event
Malfunction
·BIOMET, INC.·Product code LXH·February 18, 2008
ATELLICA NEPH 630 SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH·Product code JZW·May 26, 2022
LOCKING SCREWDRIVER BODY
FDA Adverse Event
Malfunction
·DEPUY FRANCE SAS - 3003895575·Product code HXX·March 20, 2018
LOCKING SCREWDRIVER BODY
FDA Adverse Event
Malfunction
·DEPUY FRANCE SAS - 3003895575·Product code HXX·February 2, 2018
ATELLICA NEPH 630 SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH·Product code JZW·December 10, 2021
ATELLICA NEPH 630 SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH·Product code JZW·February 21, 2022
LOCKING SCREWDRIVER BODY
FDA Adverse Event
Malfunction
·DEPUY FRANCE SAS - 3003895575·Product code HXX·October 23, 2019
Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ14; Product is manufactured and distributed by Sunrise Medical (US) LLC., Fresno, CA. Used by a person to move from one place to another while sitting.
FDA Enforcement
Class II
·Terminated·Sunrise Medical (US) LLC·December 11, 2013