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
9145–9168 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 25, 2023
Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter
K230928 · OWQ
Vein 360, LLC
Cardiovascular · 144d
Cleared Aug 25, 2023
Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully...
K230566 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 177d
Cleared Aug 25, 2023
Wrist Type Blood Pressure Monitor (W05,W1101L)
K230409 · DXN
Shenzhen Jamr Technology Co., Ltd.
Cardiovascular · 191d
Cleared Aug 25, 2023
VitalFlow™ Console
K230364 · QNR
Michigan Critical Care Consultants,...
Cardiovascular · 196d
Cleared Aug 25, 2023
Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé...
K230165 · EZD
Coloplast
Gastroenterology & Urology · 217d
Cleared Aug 25, 2023
Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors
K230094 · MBI
Responsive Arthroscopy, LLC
Orthopedic · 225d
Cleared Aug 25, 2023
MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100,...
K230014 · QPL
Tonica Elektronik A/S
Physical Medicine · 234d
Cleared Aug 25, 2023
VitalFlowTM Centrifugal Pump
K223898 · QNR
Michigan Critical Care Consultants,...
Cardiovascular · 240d
Cleared Aug 25, 2023
Reusable Temperature Probe, Disposable Temperature Probe
K223807 · FLL
Shenzhen Sino-K Medical Technology...
General Hospital · 248d
Cleared Aug 25, 2023
Lavieen
K223727 · GEX
Wontech Co., Ltd.
General & Plastic Surgery · 255d
Cleared Aug 25, 2023
Sterilization Wrap
K223600 · FRG
Wuhan Zonsen Medical Products Co., Ltd.
General Hospital · 266d
Cleared Aug 25, 2023
AIRAscore
K223180 · LLZ
Airamed GmbH
Radiology · 318d
Cleared Aug 25, 2023
BioProtect Balloon Implant™ System
K222972 · OVB
Bioprotect, Ltd.
Radiology · 332d
Cleared Aug 25, 2023
072 Aspiration System
K222786 · NRY
Q'Apel Medical, Inc.
Neurology · 344d
Cleared Aug 25, 2023
BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood...
K213670 · GIM
Becton, Dickinson and Company
Hematology · 641d
Cleared Aug 24, 2023
Essenz HLM, Essenz ILBM
K232291 · DTQ
Livanova Deutschland, GmbH
Cardiovascular · 23d
Cleared Aug 24, 2023
Zenius™ Spinal System
K232218 · NKB
Medyssey USA, Inc.
Orthopedic · 29d
Cleared Aug 24, 2023
Quantra Hemostasis Analyzer
K232215 · QFR
Hemosonics, LLC
Hematology · 29d
Cleared Aug 24, 2023
CATAMARAN SI Joint Fusion System
K231944 · OUR
Tenon Medical, Inc.
Orthopedic · 55d
Cleared Aug 24, 2023
AccelFix Lumbar Expandable Cage System
K231680 · MAX
L & K Biomed Co., Ltd.
Orthopedic · 76d
Cleared Aug 24, 2023
Instrument Case
K231604 · KCT
Cochlear Americas
General Hospital · 84d
Cleared Aug 24, 2023
Stryker MP, Mandible, HMMF and MMF AXS Screws
K231599 · DZL
Stryker Leibinger GmbH & Co KG
Dental · 84d
Cleared Aug 24, 2023
ZENEX FreeMilling & CCM Cast Abutment
K231557 · NHA
Izenimplant Co., Ltd.
Dental · 86d
Cleared Aug 24, 2023
Current Health System
K231506 · MSX
Current Health , Ltd.
Cardiovascular · 92d