24 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PAL (PN 4132)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040013816·Zirlux 16+ A3.5 98.5X18
TiWAVE L Lumbar Cage System
FDA UDI
Kalitec Direct LLC·B07323K0101130·Distractor, Smooth Paddle, Lordotic, 13mm
READERS CHOICE
FDA UDI
FGX INTERNATIONAL INC.·00193033243350·
READERS CHOICE
FDA UDI
FGX INTERNATIONAL INC.·00193033243367·
READERS CHOICE
FDA UDI
FGX INTERNATIONAL INC.·00193033243343·
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0101130·Distractor, Smooth Paddle, 13mm
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0110130·Sounder, Ball Tip, Straight, Soft, Titanium
iTotal Identity Posterior Stabilized Knee Replacement System
FDA UDI
Conformis, Inc.·M572TPS3011113011·ITOTAL IDENTITY PS TIBIAL TRAY, (TITANIUM, CEME...
iTotal Identity Posterior Stabilized Knee Replacement System
FDA UDI
Conformis, Inc.·M572RPS3011113011·ITOTAL IDENTITY PS REPLACEMENT TIBIAL TRAY (TIT...
iTotal Identity CR
FDA UDI
Conformis, Inc.·M572RCR3011113011·ITOTAL IDENTITY CR REPLACEMENT TIBIAL TRAY (TIT...
LASER MECHANISMS LASER SCANNING SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
IVC THREE BLASTOCYST MEDIUM, CAT # 2007
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MOTO PARTIAL KNEE SYSTEM - MEDIAL
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code HSX·December 24, 2025
ENDOTRACH TUBE 8229506 CONTACT EMG 6MM
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED, INC.·Product code ETN·March 14, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·March 8, 2011
TENDRIL SDX
FDA Adverse Event
Injury
·TELECTRONICS PACING SYSTEMS·Product code DTB·March 10, 2008
iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101
FDA Enforcement
Class II
·Completed·Conformis, Inc.·April 20, 2022
iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101
FDA Recall
Completed
·Conformis, Inc.·Product code JWH·February 22, 2022
BD INTREGRA¿ SYRINGE WITH DETACHABLE NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code MEG·September 3, 2021