Search FDA 510(k) Devices

5,474 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2024–2024 ×
3,129 results
1993–2016 of 3,129
Cleared May 21, 2024
Safety lancet (XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV.)
K240806 · FMK
Tianjin Huahong Technology Co., Ltd.
General & Plastic Surgery · 57d
Cleared May 21, 2024
ProSeal™ Injection Site Extended Male Luer Lock (422140)
K240433 · ONB
Epic Medical Pte. , Ltd.
General Hospital · 97d
Cleared May 21, 2024
YSIO X.pree
K233543 · KPR
Siemens Medical Solutions
Radiology · 200d
Cleared May 21, 2024
troCarWash™ System
K233442 · OCX
Biotex, Inc.
General & Plastic Surgery · 216d
Cleared May 21, 2024
21.3” 3MP Color LCD Display UMD3-21B01 (MD3-21B01)
K233336 · PGY
Acula Technology Corp.
Radiology · 235d
Cleared May 21, 2024
Yumizen H2500
K232946 · GKZ
HORIBA ABX SAS
Hematology · 244d
Cleared May 21, 2024
Viewer (5.4)
K232759 · LLZ
Brainlab AG
Radiology · 256d
Cleared May 21, 2024
Reia pessary
K232677 · HHW
Reia, LLC
Obstetrics & Gynecology · 263d
Not Cleared May 21, 2024
3M™ Attest™ eBowie-Dick Test Card 10135 3M™ Attest™ eBowie-Dick Card Holder...
DEN230068 · JOJ
3M Company
General Hospital · 235d
Cleared May 20, 2024
Vector™ Pedicle Screw System
K241276 · NKB
Innovasis, Inc.
Orthopedic · 14d
Cleared May 20, 2024
Disposable Vinyl Examination Gloves
K241252 · LYZ
Anqing Pukang Medical Technology Co.,...
General Hospital · 17d
Cleared May 20, 2024
Dental Zirconia Blank (HT-plus, ST-C, ST-ML, SHT-C, SHT-ML, UT-C, UT-ML,...
K240772 · EIH
Hunan Ceramaster Material Technology...
Dental · 60d
Cleared May 20, 2024
Diode Laser Hair Removal System (SH-VD910)
K240520 · GEX
Beijing Sea Heart International...
General & Plastic Surgery · 87d
Cleared May 20, 2024
Dentis s-Clean SQ-SL Fixture
K240511 · DZE
Dentis Co., Ltd.
Dental · 88d
Cleared May 20, 2024
Multi-function Platform Systems (BL-M10)
K240474 · GEX
Shanghai Bele Medical Technology Co.,Ltd
General & Plastic Surgery · 90d
Cleared May 20, 2024
MIM - Centiloid Scaling
K233620 · LLZ
Mim Software, Inc.
Radiology · 189d
Cleared May 20, 2024
Fogarty Corkscrew Catheters
K233619 · DXE
Edwards Lifesciences
Cardiovascular · 189d
Cleared May 20, 2024
Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430,...
K233341 · BTR
Covidien, LLC
Anesthesiology · 234d
Cleared May 20, 2024
Solo+ Tympanostomy Tube Device (TTD)
K232702 · ETD
Aventamed Dac
Ear, Nose, Throat · 258d
Cleared May 20, 2024
AViTA Pulse Oximeter
K223399 · DQA
Avita Corporation
Anesthesiology · 558d
Cleared May 17, 2024
MiRus MoRe Lumbar Plating System
K241175 · KWQ
MiRus, LLC
Orthopedic · 21d
Cleared May 17, 2024
SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)
K241042 · DRC
Pressure Products Medical Device...
Cardiovascular · 30d
Cleared May 17, 2024
ARENAL Anterior Cervical Plate System
K240935 · KWQ
Effortmed, LLC
Orthopedic · 42d
Cleared May 17, 2024
Intense Pulsed Light System (ST-690)
K240482 · ONF
Smedtrum Medical Technology Co., Ltd.
General & Plastic Surgery · 87d