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
3217–3240 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 01, 2025
SonoMSK
K243690 · BSP
PAJUNK GmbH Medizintechnologie
Anesthesiology · 214d
Cleared Jul 01, 2025
Alinity m CMV
K243485 · PAB
Abbott Molecular, Inc.
Microbiology · 235d
Cleared Jun 30, 2025
Otsuka Digital Feedback Device
K251088 · OZW
Otsuka America Pharmaceutical, Inc.
Cardiovascular · 82d
Cleared Jun 30, 2025
Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07,...
K251000 · OHT
Shenzhen Chuangtong Yigou Technology...
General & Plastic Surgery · 90d
Cleared Jun 30, 2025
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K250990 · JWY
Thermo Fisher Scientific
Microbiology · 91d
Cleared Jun 30, 2025
aprevo® posterior/transforaminal lumbar interbody fusion device
K250987 · MAX
Carlsmed, Inc.
Orthopedic · 91d
Cleared Jun 30, 2025
EchoConfidence (USA)
K250670 · QIH
Mycardium AI Limited
Radiology · 117d
Cleared Jun 30, 2025
PIUR tUS inside
K250484 · QIH
Piur Imaging GmbH
Radiology · 131d
Cleared Jun 30, 2025
HeroTracker Sense
K250022 · CAF
Voluntis
Anesthesiology · 178d
Cleared Jun 30, 2025
Synapse PACS (7.5)
K243647 · QIH
Fujifilm Healthcare Americas Corporation
Radiology · 216d
Cleared Jun 29, 2025
Primum Hydrophilic Guiding Catheter
K250972 · DQY
Pendracare
Cardiovascular · 90d
Cleared Jun 27, 2025
T3 Pro Implants– ZimVie Packaging System
K251660 · DZE
Biomet 3i, LLC
Dental · 28d
Cleared Jun 27, 2025
BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded...
K251654 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 28d
Cleared Jun 27, 2025
Dental CBCT X-ray System
K251642 · OAS
Yian Medical Technology (Haining)...
Radiology · 29d
Cleared Jun 27, 2025
FIX-C PEEK ACIF SA System
K251431 · OVE
Jeil Medical Corporation
Orthopedic · 50d
Cleared Jun 27, 2025
Diode laser device (RF3120-BI)
K251329 · GEX
Risu Medical Technology Co., Ltd.
General & Plastic Surgery · 58d
Cleared Jun 27, 2025
Ampa One System (AMPA-001)
K251210 · OBP
Neuromodulatory Devices & Applications
Neurology · 70d
Cleared Jun 27, 2025
Luja Coudé
K251116 · EZD
Coloplast Corp.
Gastroenterology & Urology · 77d
Cleared Jun 27, 2025
Maestro System (REF100)
K250984 · QZB
Moon Surgical
General & Plastic Surgery · 88d
Cleared Jun 27, 2025
JET BITE
K250969 · ELW
Dent4you AG
Dental · 88d
Cleared Jun 27, 2025
CPS Locator 3D Plus Delivery Catheter
K250828 · DQY
CenterPoint Systems, LLC
Cardiovascular · 100d
Cleared Jun 27, 2025
Philips iCT CT system
K250648 · JAK
Philips Medical Systems Nederland B.V.
Radiology · 115d
Cleared Jun 27, 2025
Easyflow (103-200
K250610 · DWF
Sorin Group Italia S.R.L.
Cardiovascular · 119d
Cleared Jun 27, 2025
LumenaTM Ureteral Access Sheath
K250585 · FED
Cathegenix (Xiamen) Co., Ltd.
Gastroenterology & Urology · 120d