FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
8689–8712 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 11, 2023
VASSALLO GT Crossing14
K232574 · DQX
Filmec Co. , Ltd.
Cardiovascular · 47d
Cleared Oct 11, 2023
IPL Hair Removal Device (LS-T106, LS-T107, LS-T108)
K232499 · OHT
Shenzhen Lescolton Electrical...
General & Plastic Surgery · 55d
Cleared Oct 11, 2023
Disposable electrosurgical pencil (MD1000)
K232460 · GEI
Shenzhen Mecun Medical Supply Co., Ltd.
General & Plastic Surgery · 57d
Cleared Oct 11, 2023
Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR
K232344 · OWB
GE Medical Systems SCS
Radiology · 68d
Cleared Oct 11, 2023
JO Coconut Hybrid Warming Personal Lubricant
K232090 · NUC
CC Wellness, LLC
Obstetrics & Gynecology · 90d
Cleared Oct 11, 2023
Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy...
K232070 · LZA
Better Care Plastic Technology Co., Ltd.
General Hospital · 91d
Cleared Oct 11, 2023
Arm Blood Pressure Monitor
K231050 · DXN
Alicn Medical (Shenzhen), Inc.
Cardiovascular · 181d
Cleared Oct 11, 2023
Anterion
K230897 · OBO
Heidelberg Engineering GmbH
Ophthalmic · 194d
Cleared Oct 11, 2023
MegaGen Dental Implant Systems Portfolio - MR Conditional
K230618 · DZE
Megagen Implant Co., Ltd.
Dental · 219d
Cleared Oct 11, 2023
NeuViz 128 Multi-Slice CT Scanner System
K230220 · JAK
Neusoft Medical Systems Co., Ltd.
Radiology · 258d
Cleared Oct 11, 2023
Vlab
K230148 · GWL
Dormotech Medical, Ltd.
Neurology · 265d
Cleared Oct 11, 2023
Vital™ Spinal Fixation System
K230116 · NKB
Zimvie Spine (Zimmer Biomet Spine, Inc.)
Orthopedic · 267d
Cleared Oct 11, 2023
SurgiAid® Collagen Wound Dressing
K223126 · KGN
Maxigen Biotech, Inc.
General & Plastic Surgery · 373d
Cleared Oct 11, 2023
G4Derm / G4Derm Plus Synthetic Wound Matrix
K222025 · FRO
Gel4med, Inc.
General & Plastic Surgery · 457d
Cleared Oct 10, 2023
ID NOW Influenza A & B 2
K232775 · OCC
Abbott Diagnostics Scarborough, Inc.
Microbiology · 29d
Cleared Oct 10, 2023
Vy Spine™ VyLam™ Laminoplasty System
K232471 · NQW
Vy Spine, LLC
Orthopedic · 55d
Cleared Oct 10, 2023
CarboClear® Pedicle Screw System
K232341 · NKB
CarboFix Orthopedics , Ltd.
Orthopedic · 67d
Cleared Oct 10, 2023
VEOS Spinal Fixation System
K231658 · NKB
Spineway
Orthopedic · 125d
Cleared Oct 10, 2023
IPD Dental Implant Abutments
K231413 · NHA
Implant Protesis Dental 2004, S.L.
Dental · 147d
Cleared Oct 10, 2023
Zeus Spinal System
K230961 · NKB
Shanghai Sanyou Medical Co, Ltd.
Orthopedic · 188d
Cleared Oct 10, 2023
WeSensor
K230916 · MUH
Picopack, Inc.
Radiology · 190d
Cleared Oct 10, 2023
Micromate™ Navi+
K230130 · JAK
Isys Medizintechnik GmbH
Radiology · 266d
Cleared Oct 10, 2023
NeuroTrigger Basic (NTB)
K223027 · IPF
Neurotrigger
Physical Medicine · 376d
Cleared Oct 06, 2023
ScanNav Anatomy Peripheral Nerve Block
K232787 · QRG
Intelligent Ultrasound Limited
Anesthesiology · 25d