23 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
DUOFLEX COIL SUITE (1.5T)
FDA 510(k)
FDA Class 2
·Radiology
Humelock II Cemented Reversible Shoulder
FDA UDI
FX SOLUTIONS·03701037303511·TRIAL HUMERAL CUP 135/145° STANDARD Ø36 +6
Humelock II Cemented Reversible Shoulder
FDA UDI
FX SOLUTIONS·03701037301364·HUMERAL CUP 135/145° STANDARD PE/TA6V Ø36 +6
Humelock II Cemented Reversible Shoulder
FDA UDI
FX SOLUTIONS·03701037314005·STANDARD TRIAL HUMERAL CUP CUSTOM MADE 135/145°...
K2M General Instruments
FDA UDI
VB Spine LLC·10888857560871·Forward Angled Curette Size #4
VENUS BASIC SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
EBI DYNAFIX COMPRESSION BONE SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
HUMERIS
FDA Adverse Event
Injury
·FX SOLUTIONS·Product code HSD·June 4, 2019
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code ODG·July 24, 2021
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code ODG·July 21, 2021
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 24, 2013
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·September 30, 2014
ENRHYTHM DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·June 16, 2011
UNKNOWN
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·July 26, 2024
ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·October 6, 2022
UNKNOWN
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·July 15, 2020
ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·February 9, 2023
ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·December 6, 2024
SS 3.2MM Pellet Insertion Tray Catalog Number: B8110R1
FDA Enforcement
Class II
·Terminated·Busse Hospital Disposables, Inc.·June 8, 2022
Abbott brand FreeStyle Flash Blood Glucose Meter, distributed by Abbott Diabetes Care, 1420 Harbor Bay Pwky. Alameda, CA 94502. Manufactured by: Flextronics International, Long Jing Industrial Estate, Long Jing Road, Xi Li Town, Nantou District, Shenzhen, China
FDA Recall
Terminated
·Abbott Diabetes Care, Inc.·Product code NBW·May 22, 2006