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.

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

Filters: Cleared only ×
175,230 results
158857–158880 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 05, 1982
SUNROOF SUNLAMP
K827098
Sunfun Enterprises , Ltd.
Radiology · 20d
Cleared Oct 05, 1982
SPECTRA MINI, ULTRAVIOLET EMITTER FOR DERMATOLOGICAL USE
K827690
Daavlin Co.
Radiology · 15d
Cleared Oct 05, 1982
LASER LAPAROSCOPE
K828194
Laser Industries , Ltd.
Radiology · 27d
Cleared Oct 04, 1982
CARDIO TEHCHANALYZER
K821711 · DSI
Cardio Technology , Ltd.
Cardiovascular · 117d
Cleared Oct 04, 1982
COAXIAL BIPOLAR PACING ELECTRODE
K822239 · DTB
Burditt & Calkins-Siemens-Elema
Cardiovascular · 68d
Cleared Oct 04, 1982
ENERTRAX MODEL 7100E
K822297 · DXY
Medtronic Vascular
Cardiovascular · 62d
Cleared Oct 04, 1982
COMMAND NP
K822309 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 62d
Cleared Oct 04, 1982
ALTA III ECG RECORDER
K822363 · DSH
Scole Engineering Co.
Cardiovascular · 59d
Cleared Oct 04, 1982
ACKRAD BRONCHITRAC
K822398 · BSY
Ackrad Laboratories
Anesthesiology · 55d
Cleared Oct 04, 1982
M-MODE ANALYSIS SYSTEM
K822425 · DXK
User Resources, Inc.
Cardiovascular · 53d
Cleared Oct 04, 1982
TOTAL KNEE SYSTEM
K822583 · MBV
Richard'S Medical Equip., Inc.
Orthopedic · 39d
Cleared Oct 04, 1982
PRESSURE ISOLATION AMPLIFIER #9813 517
K822590 · DRJ
Honeywell, Inc.
Cardiovascular · 27d
Cleared Oct 04, 1982
MK 808 SERIES NASAL OXYGEN SAMPLER
K822608 · CCL
Instrumentation Industries, Inc.
Anesthesiology · 35d
Cleared Oct 04, 1982
MONOJECT PLASTIC HUB SPINAL NEEDLE
K822630 · BSP
Sherwood Medical Co.
Anesthesiology · 34d
Cleared Oct 04, 1982
JAIN INSULATING BOOT MODEL 225B
K822652 · DXY
Cook Pacemaker Corp.
Cardiovascular · 32d
Cleared Oct 04, 1982
CURING LIGHT
K822654 · EBZ
Venture Technology, Inc.
Dental · 32d
Cleared Oct 04, 1982
REUSABLE FOGARTY FLEXIBLE CALIBRATOR
K822687 · DWP
American Edwards Laboratories
Cardiovascular · 31d
Cleared Oct 04, 1982
DEL MAR MODEL 5500 EEG SCANNER
K822700 · GWQ
Del Mar Avionics
Neurology · 27d
Cleared Oct 04, 1982
SERIES 7000 BEDSIDE PATIENT MONITOR
K822718 · DSI
Marquette Electronics, Inc.
Cardiovascular · 27d
Cleared Oct 04, 1982
EAR/ULCER SYRINGE
K822754 · KCP
American Hospital Supply Corp.
Ear, Nose, Throat · 26d
Cleared Oct 04, 1982
ELECTROCARDIOGRAPH (74 DPS) #YM-102
K822768 · DPS
Sanyo Electric, Inc.
Cardiovascular · 20d
Cleared Oct 04, 1982
PHONIC EAR-PE 845-PPC
K822779 · ESD
Phonic Ear, Inc.
Ear, Nose, Throat · 20d
Cleared Oct 04, 1982
DISSCAP 080
K822851 · FKQ
Hospal Medical Corp.
Gastroenterology & Urology · 10d
Cleared Oct 04, 1982
ULTRA IMAGER
K827408
Honeywell, Inc.
Radiology · 68d