28 results
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27ms
·
Sources: EU EUDAMED, US FDA
Healgen® URS Test Strips
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Ophthalmic Forceps
FDA UDI
KATENA PRODUCTS, INC.·00841668106174·PIERSE FORCEPS 0.1MM STRAIGHT
Q-FIX
FDA UDI
Smith & Nephew, Inc.·00885556724606·1.8MM Q-FIX ALL SUTURE ANCHOR
IPL HAIR REMOVAL DEVICE CT05
FDA Adverse Event
Injury
·SHENZHEN CHUANGTONG YIGOU TECHNOLOGY CO., LTD.·Product code OHT·February 19, 2026
HAND-HELD HAIR REMOVAL DEVICE
FDA Adverse Event
Injury
·SHENZHEN CHUANGTONG YIGOU TECHNOLOGY CO., LTD.·Product code OHT·March 9, 2026
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702782721·ELVAREX 2/KNEE HIGH/SLANT-OPEN TOE-ELEPHANTIASI...
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011251800150·ceraMotion® Ti 8 Shade Set / dental ceramic mat...
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011251800450·ceraMotion® Ti Chroma Concept Set / dental cera...
IdentiTi
FDA UDI
ALPHATEC SPINE, INC.·00190376383552·LIF, GRAFT CONTAINMENT CLIP, 18MM 0°
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011251800500·ceraMotion® Ti Touch Up Set / dental ceramic ma...
IN6 SAFETY SYRINGE, MODEL 3ML
FDA 510(k)
FDA Class 2
·General Hospital
Portable Dental X-ray (NR-F350, CS 2400P, CS 2300P, R2 Port-X)
FDA 510(k)
FDA Class 2
·Dental
Omnia Medical TiBrid™-L
FDA UDI
OMNIA MEDICAL, LLC·00843511106522·LATERAL INTERBODY, 22x45x18mm, 0°
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·August 31, 2011
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·November 14, 2014
PELVICOL 2CM X 7CM 1.0MM
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TISSUE·Product code FTL·July 18, 2013
BFLEX 2 REGULAR 5.0 SINGLE-USE BRONCHOSCOPE
FDA Adverse Event
Malfunction
·VERATHON MEDICAL ULC·Product code EOQ·August 5, 2025
20 G X 1.16 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·December 28, 2016
Diagnostica Stago STA N¿oplastine¿ CI Plus, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma. (REF 00667) The STA¿ - N¿oplastine¿ CI Plus kits provide reagents for the determination of the prothrombin time (PT) in plasma with STA-R¿, STA Compact¿ and STA Satellite¿. (In the USA this procedure has been assigned to the moderate complexity category per CLIA 1988 - CDC Analyte Code 4922; CDC Test System Codes 4677 and 4875).
FDA Enforcement
Class II
·Terminated·Diagnostica Stago, Inc.·September 19, 2018
Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.
FDA Recall
Open, Classified
·Philips North America·Product code LNH·April 14, 2026