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
159481–159504 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 01, 1982
TITAN GEL CPK ISOENZYME SYSTEM
K822124 · JHT
Helena Laboratories
Chemistry · 105d
Cleared Nov 01, 1982
INTRAOPERATIVE BALLOON DILATION CATH.
K822393 · DQY
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 84d
Cleared Nov 01, 1982
CENTURION CHART RECORDER
K822432 · DSF
Clinical Data, Inc.
Cardiovascular · 81d
Cleared Nov 01, 1982
CYTOMEGALOVIRUS ANTOBODY IGG
K822606 · LIN
Immulok, Inc.
Microbiology · 66d
Cleared Nov 01, 1982
MEDI-TRACE 5' OFFSET ELECTRODE
K822750 · DRX
Graphic Controls Corp.
Cardiovascular · 49d
Cleared Nov 01, 1982
BLOOD OXYGENATORS #BOS-105S BOS-5S W/
K822803 · DTZ
Bentley Laboratories, Inc.
Cardiovascular · 45d
Cleared Nov 01, 1982
BALLOON WEDGE PRESSURE, ANGIOGRAPHIC
K822806 · DYG
Nova Medical Specialties
Cardiovascular · 45d
Cleared Nov 01, 1982
ACCESS PERCUTANEOUS INTRODUCER SET
K822834 · DYB
Access Devices, Inc.
Cardiovascular · 41d
Cleared Nov 01, 1982
STOOL-COLLECTION/PRESERVATION KIT
K822870 · KDT
American Scientific Products
Microbiology · 35d
Cleared Nov 01, 1982
CORTISOL RIA KIT
K822892 · CGR
Antibodies, Inc.
Chemistry · 34d
Cleared Nov 01, 1982
AUTOECHO
K822903 · DXG
Oxford Medilog, Inc.
Cardiovascular · 34d
Cleared Nov 01, 1982
KALOS-03 BIPOLAR
K822907 · DXY
Biotronik Sales, Inc.
Cardiovascular · 32d
Cleared Nov 01, 1982
PULSE OXIMETER MODEL 100
K822909 · DQA
Nellcor, Inc.
Anesthesiology · 32d
Cleared Nov 01, 1982
MODEL 5400 OPTOKINETIC STIMULATOR
K822917 · HOW
Life-Tech Intl., Inc.
Ophthalmic · 31d
Cleared Nov 01, 1982
CSM CHROMOGENIC B-LACTAMASE DISC
K822930 · JTO
Carr-Scarborough Microbiologicals, Inc.
Microbiology · 28d
Cleared Nov 01, 1982
THYROID STIMULATING HORMONE
K822935 · JLW
Pcl-Ria, Inc.
Chemistry · 28d
Cleared Nov 01, 1982
560
K822952 · DRT
Kone Instruments, Inc.
Cardiovascular · 28d
Cleared Nov 01, 1982
MODEL 4242 TELE SYST ARRHYTHMIA MONITOR
K822955 · DXH
Medtronic Vascular
Cardiovascular · 27d
Cleared Nov 01, 1982
PORTA FIB III
K822961 · LDD
Narco Scientific
Cardiovascular · 27d
Cleared Nov 01, 1982
IL 801 THERMALDILUTION CARDIAC OUTPUT
K822972 · DXG
Instrumentation Laboratory CO
Cardiovascular · 24d
Cleared Nov 01, 1982
OPTICATH HEPARIN COATED, FLOW-DIRECT
K823007 · DYG
Oximetrix, Inc.
Cardiovascular · 20d
Cleared Nov 01, 1982
DIGOXIN KIT
K823014 · DPB
Pcl-Ria, Inc.
Toxicology · 19d
Cleared Nov 01, 1982
INTRAVENOUS CATHETER PLACEMENT UNIT &
K823017 · FOZ
Access Devices, Inc.
General Hospital · 19d
Cleared Oct 29, 1982
SOFT LENS THERMAL DISINFECTING UNIT, A-C
K822828 · HRD
Safeway Products, Inc.
Ophthalmic · 38d