24 results
·
36ms
·
Sources: EU EUDAMED, US FDA
Yumizen C1200 CRP
FDA 510(k)
FDA Class 2
·Immunology
Bernafon
FDA UDI
Bernafon AG·05711584087480·ZR1, KIT 10 NFM 75 BE ZERENA 1
OsteoMed
FDA UDI
OSTEOMED LLC·00845694015370·2.0mm x 28mm Cannulated Lag Screw
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776199937·LLETZ WPEDERSON SPECULUM LARGE RIGHT
OsteoMed
FDA UDI
OSTEOMED LLC·00845694070348·Cannulated 2.0 x 28mm Lag Screw Sterile Qty 5
PHILIPS AVALON FETAL MONITORS FM20, FM30, FM40, AND FM50
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
NEOTRACT ANCHOR SYSTEM MODEL TAS400
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
JUGGERSTITCH CURVED IMPLANT
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code MBI·May 28, 2025
JUGGERSTITCH CURVED IMPLANT
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code MBI·May 28, 2025
TANDEM MOBI INSULIN PUMP WITH CONTROL-IQ+ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·December 4, 2025
ARTIC/EZE TR BALL GRVD 32+1
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LXH·October 6, 2008
AVAULTA SOLO ANTERIOR SYNTHETIC SUPPORT SYSTEM
FDA Adverse Event
Injury
·BARD SHANNON LIMITED·Product code OTP·June 20, 2013
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·August 4, 2011
COMPREHENSIVE REVERSE 25 MM BASEPLATE HA + ADAPTER
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·September 5, 2018
BLUNT TIP SCREW, ÿ 4X50MM
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code HRS·April 28, 2025
AFFIXUS HUM SCREW & END CAPS
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code HSB·December 21, 2023
BLUNT TIP SCREW, ÿ 4X56MM
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code HRS·April 28, 2025
Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029
FDA Enforcement
Class II
·Ongoing·Merit Medical Systems, Inc.·August 20, 2025
DEX Ophthalmic Tissue Forceps, 25ga DEX Super Grip Forceps, Model/Catalog Number: DVF4034-25
FDA Enforcement
Class II
·Ongoing·Katalyst Surgical, LLC·May 13, 2026
Custom Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A, K09-11456B, K09-12123B, K09-13342AP, K09-13391BP, K09-13548, K09-14000A, K09T-12020D, K09T-12275B
FDA Enforcement
Class II
·Ongoing·Merit Medical Systems, Inc.·August 20, 2025