FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
7273–7296 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 26, 2024
BioStar Single Use Transbronchial Aspiration Needle
K232038 · EOQ
Broncus Medical, Inc.
Anesthesiology · 291d
Cleared Apr 26, 2024
ASTar BC G- Kit and ASTar Instrument
K221688 · SAN
Q-Linea AB
Microbiology · 686d
Cleared Apr 26, 2024
cobas pulse blood glucose monitoring system
K220272 · PZI
Roche Diagnostics
Chemistry · 816d
Cleared Apr 25, 2024
Dental Cone-beam Computed Tomography
K240855 · OAS
Yian Medical Technology (Haining)...
Radiology · 28d
Cleared Apr 25, 2024
CarboClear® Hybrid Pedicle Screw System
K240846 · NKB
CarboFix Orthopedics , Ltd.
Orthopedic · 29d
Cleared Apr 25, 2024
Digital ClarusScope System
K240535 · HRX
Clarus Medical, LLC
Orthopedic · 59d
Cleared Apr 25, 2024
CDI OneView Monitoring System
K234065 · DRY
Terumo Cardiovascular Systems...
Cardiovascular · 125d
Cleared Apr 25, 2024
Portrait VSM
K233810 · MWI
Ge Medical Systems Information...
Cardiovascular · 147d
Cleared Apr 25, 2024
Air Motor (Model name: FX204 M4)
K233308 · EFB
Nakanishi, Inc.
Dental · 209d
Cleared Apr 25, 2024
Kronos Electrocautery Device
K232805 · GEI
Single Pass, Inc.
General & Plastic Surgery · 226d
Cleared Apr 25, 2024
LUOFUCON® Collagen Particles (Collagen Wound Dressing)
K232796 · KGN
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery · 226d
Cleared Apr 25, 2024
ENDOFIX EXO
K232405 · OCV
Aktormed GmbH
General & Plastic Surgery · 259d
Cleared Apr 25, 2024
Copan Universal Transport Medium (UTM-RT) System
K232357 · JSM
Copan Italia Spa
Microbiology · 262d
Cleared Apr 25, 2024
InVision Precision LVEF (LVEF)
K232331 · QIH
Invision Medical Technology Corporation
Radiology · 265d
Cleared Apr 25, 2024
1) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture
K232246 · NEW
M/s. Meril Endo Surgery Private Limited.
General & Plastic Surgery · 272d
Cleared Apr 25, 2024
Temporis, Irix Plus
K231142 · EBF
Dws S.R.L.
Dental · 370d
Cleared Apr 24, 2024
EPIQ Series Diagnostic Ultrasound Systems
K240850 · IYN
Philips Ultrasound, LLC
Radiology · 28d
Cleared Apr 24, 2024
OpenRad Cloud
K240839 · LLZ
Openrad Services Uk, Ltd.
Radiology · 28d
Cleared Apr 24, 2024
Image Management V15
K240822 · LLZ
Philips Medical Systems Technologies
Radiology · 30d
Cleared Apr 24, 2024
Omnia Medical TiBrid™-SA System
K240623 · OVD
Omnia Medical, LLC
Orthopedic · 50d
Cleared Apr 24, 2024
DORO LUCENT Skull Clamp (1101.001)
K240319 · HBL
Pro-Med Instruments GmbH
Neurology · 82d
Cleared Apr 24, 2024
DESS Dental Smart Solutions
K240208 · NHA
Terrats Medical SL
Dental · 90d
Cleared Apr 24, 2024
IPL Home Use Hair Removal Device (SJ15)
K240093 · OHT
Shenzhen Shuge Medical Beauty Devices...
General & Plastic Surgery · 103d
Cleared Apr 24, 2024
canturio® se (Canturio Smart Extension)
K234056 · QPP
Canary Medical USA, LLC
Orthopedic · 124d