14 results · 29ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

VLP 2.7MM EXTRA LARGE PERCUTANEOUS CALCANEUS PLATE, PERI-LOC 3.5MM ANTERIOR ANKLE FUSION PLATES, PERI-LOC 3.5MM HINDFOOT

FDA 510(k)
FDA Class 2 ·Orthopedic

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197037754·Goldman Fox Gum Scissors curved...

CODMAN HAKIM SHUNT SYSTEMS

FDA 510(k)
FDA Class 2 ·Neurology

IMAGE-ARENA AND IMAGE-ARENA APPLICATIONS

FDA 510(k)
FDA Class 2 ·Radiology

SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE·Product code FKX·May 20, 2013

ACCESS® 2 IMMUNOASSAY SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code MMI·June 10, 2011

GENERATOR MODEL

FDA Adverse Event
Injury ·CYBERONICS, INC.·Product code LYJ·August 14, 2008

EAGLE EYE PLATINUM SHORT TIP

FDA Adverse Event
Injury ·VOLCANO CORPORATION·Product code OBJ·July 1, 2016

EAGLE EYE PLATINUM SHORT TIP; EAGLE EYE PLATINUM ST CATHETER

FDA Adverse Event
Injury ·VOLCANO CORPORATION·Product code OBJ·July 1, 2016

EAGLE EYE PLATINUM SHORT TIP; EAGLE EYE PLATINUM ST CATHETER

FDA Adverse Event
Injury ·VOLCANO CORPORATION·Product code OBJ·July 1, 2016

VERSE POLY DRIVER SHAFT NAV

FDA Adverse Event
Malfunction ·DEPUY SPINE INC·Product code OLO·April 29, 2022

13 X 75 MM X 4.0 ML BD VACUTAINER® PLUS PLASTIC WHOLE BLOOD TUBE

FDA Adverse Event
Injury ·BECTON, DICKINSON & CO.·Product code JKA·January 22, 2016

Merit Medical Surgical Convenience Kits, Custom and SPPT, Merit Medical, South Jordan, UT 84065. Part numbers: K05-01767A, K05-01769, K05-01769A, K09-03843M, K09-03951M, K09-05894F, K09-08610, K10-00033Q, K10-00382M, K10-00685K, K10-00984F, K10-01531F, K10-01826D, K10-01826F, K10-02902B, K10-03080D, K10-03378C, K10-03397B, K10-03590A, K10-03590B, K10-03659D, K10-03659F, K10-03659G, K10-03689, K10-03907B, K12-01342D, K12-01444B, K12-01468, K12-01484A, K12-01487, K12-01490A, K12-01593, K12-01638, K12-01661, K12-01667, K12-01667A, K12-01964, K12-01968, K12-02098, SPPT-100/C, SPPT-5F-10C, SPPT-5F-10L/A, SPPT-5F-7/C, SPPT-5F-7L/A.

FDA Recall
Terminated ·Merit Medical Systems, Inc·Product code LRO·August 15, 2007

Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format)  Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.)  Track interproximal decay progression over time  Patient education tool

FDA Enforcement
Class II ·Terminated·GA Industries·May 6, 2015