Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
159697–159720 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 06, 1982
PILLING DIAMOND KNIFE
K822749 · GDX
Narco Scientific
General & Plastic Surgery · 26d
Cleared Oct 06, 1982
UNIVERSAL DYNASPLINT
K822767 · IQI
Dynasplint Systems, Inc.
Physical Medicine · 22d
Cleared Oct 06, 1982
THORATEC GAS SAMPLING CONNECTOR
K822769 · CAI
Thoratec Laboratories Corp.
Anesthesiology · 22d
Cleared Oct 06, 1982
101 NEER TYPE SHOULDER
K822771 · HSD
Intermedics Orthopedics
Orthopedic · 22d
Cleared Oct 06, 1982
CERVICAL BRACE
K822780 · JEC
Jerome Medical
Orthopedic · 22d
Cleared Oct 06, 1982
FLEX ICE FREEZE PACK
K822783 · IME
Igloo Corp.
Physical Medicine · 22d
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