22 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
PEFAKIT APC-R FACTOR V LEIDEN CONTROLS
FDA 510(k)
FDA Class 2
·Hematology
CD HORIZON® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00885074033297·BONE SCREW 7042760 20 DEG ILC 7.5X60 TI
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809869705·FOR MEN 30-40 MM HG THIGH MICRO DOT BAND CLOSED...
MILLENNIUM MICROSURGICAL SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ELECSYS DHEA-S CALSET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 25, 2021
12.4 CM HEAVY DUTY LONG ATTCH
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code HBC·April 2, 2013
TEMPBOND CLEAR WITH TRICLOSAN
FDA Adverse Event
Injury
·KERR COPORATION·Product code EMA·April 6, 2011
LD CV EZTRK 2 BP IS1 4543 90CM US
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWP·May 8, 2008
DCM MAXIM PRIMARY TIBIAL BEARING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HRY·January 4, 2018
ARCOM XL 44-36 STD +3 HMRL BRG
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·November 13, 2019
COMP PRIMARY STEM 13MM MICRO
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·November 13, 2019
COMP LK SCR 3.5HEX 4.75X30 ST
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·November 13, 2019
COMP RVS TRAY +10MM CO 44MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·November 13, 2019
COMP RVSR SHLDR GLNSP +3 36MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·November 13, 2019
COMP LK SCR 3.5HEX 4.75X35 ST
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·November 13, 2019
COMP RVS CNTRL 6.5X25MM ST/RST
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·November 12, 2019
COMP RVRS 25MM BSPLT HA+ADPTR
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·June 6, 2019
Smith & Nephew FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5 Part Number: 72202901
FDA Enforcement
Class II
·Ongoing·Smith & Nephew, Inc.·April 29, 2020
Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD Inc.·December 18, 2019