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

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176,076 results
160729–160752 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 18, 1982
AUTOMATIC EXPOSURE CONTROL TYPE A3300
K827525
Advanced Instrument Development, Inc.
Radiology · 28d
Cleared Jun 17, 1982
MEDTRONIC A-V PACING SYSTEM ANALYZER
K812262 · DTC
Medtronic Vascular
Cardiovascular · 308d
Cleared Jun 17, 1982
ARTERIAL BLOOD FILTER MODEL #AF-1040
K820343 · DTM
Bentley Laboratories, Inc.
Cardiovascular · 129d
Cleared Jun 17, 1982
PEDIATRIC ARTERIAL BLOOD FILTER #AF-540
K820679 · DTM
Bentley Laboratories, Inc.
Cardiovascular · 98d
Cleared Jun 17, 1982
CR-9
K821223 · DRT
Life Science Instrumentation, Inc.
Cardiovascular · 51d
Cleared Jun 17, 1982
EXERCISE ECG ELECTRODES, REUSABLE
K821384 · DRG
Respironics, Inc.
Cardiovascular · 38d
Cleared Jun 17, 1982
MALLINCKRODT DIAG. MEDIA WARMER
K821401 · DXT
Forma Scientific, Inc.
Cardiovascular · 37d
Cleared Jun 17, 1982
WILLIAM HARVEY FLEX. VENOUS RESERVOIR
K821442 · DTN
C.R. Bard, Inc.
Cardiovascular · 35d
Cleared Jun 17, 1982
ENDOTRACHEAL TUBE
K821456 · BTR
Life-Line Products, Inc.
Anesthesiology · 34d
Cleared Jun 17, 1982
RIGHT ATRIAL CATHETERS PARENTERAL NUTRIT
K821480 · DQY
The Healthcare Group Laboratories, Inc.
Cardiovascular · 30d
Cleared Jun 17, 1982
MEDICOTEST ECG ELECTRODES
K821506 · DRX
Medicotest, Inc.
Cardiovascular · 27d
Cleared Jun 16, 1982
VIRAGARD/VIRASHIELD
K820459 · DRS
Tri-Med, Inc.
Cardiovascular · 117d
Cleared Jun 16, 1982
THERMA-SCAN
K820941
T. G. & E. Medical
General Hospital · 71d
Cleared Jun 16, 1982
PUIG MASSANA-SHILEY ANNULOPLASTY RING
K821261 · KRH
Shiley, Inc.
Cardiovascular · 44d
Cleared Jun 16, 1982
MAGUN BASE I.V. POLE
K821405 · FOX
Manuco Manufacturing Co., Inc.
General Hospital · 36d
Cleared Jun 16, 1982
STERILE TRACHEOSTOMY CARE KIT
K821501 · KDD
Pro-Pak
General & Plastic Surgery · 28d
Cleared Jun 16, 1982
OMNI TENS
K821523 · GZJ
Omni Intl., Inc.
Neurology · 26d
Cleared Jun 16, 1982
DESERET ANGIO GUIDE
K821577 · FOZ
Warner-Lambert Co.
General Hospital · 19d
Cleared Jun 16, 1982
CERVISCOPE OPTICAL SYSTEM
K821616 · HEX
Fotomedics, Inc.
Obstetrics & Gynecology · 14d
Cleared Jun 16, 1982
LATEX PENROSE DRAIN TUBING
K821700 · GAX
Abco Dealers, Inc.
General & Plastic Surgery · 8d
Cleared Jun 14, 1982
PLASTIC OR GLASS MAGNIFIER
K820375 · HJF
Gazelle Corp.
Ophthalmic · 125d
Cleared Jun 14, 1982
CILCO I/A HANDPIECE
K820933 · HQE
Cilco, Inc.
Ophthalmic · 73d
Cleared Jun 14, 1982
CHART PROJECTOR
K821081 · HOJ
Medical Equipment Designs, Inc.
Ophthalmic · 56d
Cleared Jun 14, 1982
TRIAL LENS SET
K821082 · HLH
Medical Equipment Designs, Inc.
Ophthalmic · 56d