Sep 23, 2026
K261418
Liquick X-treme, Liquick X-treme Plus
Teleflex Medical
- EZD
- Class II
510(k) clearances
Decision dates from openFDA device 510(k) records. Newest first.
746 records
Sep 23, 2026
K260995
DynaNail Helix® Fixation System
MedShape, Inc.
- HWC
- Class II
Sep 23, 2026
K260597
VIRTUE QA
ProNova Solutions
- LHN
- Class II
Sep 23, 2026
K260117
Everslide
Special Situations, LLC
- NUC
- Class II
Sep 23, 2026
K254289
Portable Oxygen Concentrator (OX-1A-E, OX-1B)
Oxytek Medical Technology Co., Ltd.
- CAW
- Class II
Sep 22, 2026
K263054
BIOFIRE Respiratory Panel 2.1 (RP2.1)
Biofire Diagnostics
- QOF
- Class II
Sep 22, 2026
K262442
HipStudio Analysis
Replasia BV
- LLZ
- Class II
Sep 22, 2026
K262390
BoneXpert
Visiana
- QIH
- Class II
Sep 22, 2026
K262299
Instant-View® hCG Combo II Cassette Test
Alfa Scientific Designs, Inc.
- JHI
- Class II
Sep 22, 2026
K261125
BodyTom 64 (NL4100); OmniTom Elite (NL5000)
Samsung HME America, Inc., dba NeuroLogica Corp.
- JAK
- Class II
Sep 22, 2026
K254240
Echo-2
Neko Health AB
- QOK
- Class II
Sep 22, 2026
K254168
Actolind® (06.3637. Actolind® Gel Plus)
ACTO GmbH
- FRO
- Unclassified
Sep 22, 2026
K253762
ErgoSteel (ES0001/696)
Strongback Mobility AG C/O Blueaudit GmbH
- IOR
- Class I
Sep 22, 2026
K243223
Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)
Bh Group Us, LLC
- PBX
- Class II
Sep 21, 2026
K262982
Core·it Dual
Spident Co., Ltd.
- EBF
- Class II
Sep 21, 2026
K262547
KARL STORZ TIPCAM1 Rubina
KALR STORZ SE & Co. KG
- OWN
- Class II
Sep 21, 2026
K262109
Access NT-proBNP
Beckman Coulter, Inc.
- NBC
- Class II
Sep 21, 2026
K262108
FAMA Male Latex Condoms – Aqueous Lubricant (Ultra-thin);FAMA Male Latex Condoms – Aqueous Lubricant (Plain);FAMA Male Latex Condoms – Aqueous Lubricant (Ribbed);FAMA Male Latex Condoms – Aqueous Lubricant (Dotted);FAMA Male Latex Condoms – Aqueous Lubricant (Non-regular Shaped);MO Male Latex Condoms – Aqueous Lubricant (Ultra-thin);MO Male Latex Condoms – Aqueous Lubricant (Plain);MO Male Latex Condoms – Aqueous Lubricant (Ribbed);MO Male Latex Condoms – Aqueous Lubricant (Dotted);MO
Shanghai Personage Hygiene Products Co., Ltd.
- HIS
- Class II
Sep 21, 2026
K261725
OtoCompanion (Version 1.0)
Ironsides Medical, Inc.
- SHL
- Class II
Sep 21, 2026
K261368
Rapid Platform (R6.7)
Ischemaview, Inc.
- QIH
- Class II
Sep 21, 2026
K260940
BellaTek Bars
ZimVie US Corp, LLC
- NHA
- Class II
Sep 21, 2026
K260512
Disposable Ureteral Access Sheath
Yangzhou Fartley Medical Instrument Technology Co., Ltd.
- FED
- Class II
Sep 21, 2026
K260416
ZYLOX Hippo PTA Balloon Dilatation Catheter
Zylox Medtech Co., Ltd.
- LIT
- Class II
Sep 21, 2026
K254280
F.A.S.T Screw
Steps Ortho
- HWC
- Class II
Sep 21, 2026
K253509
TriSalus TriNav Advance Infusion System
Trisalus Life Sciences
- KRA
- Class II