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
174217–174240 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 20, 1977
MEASLES-FA LABELLED (8-441 RF)
K770805 · GOL
Flow Laboratories, Inc.
Immunology · 17d
Cleared May 20, 1977
VARICELLA-ZOSTER FA LABELLED (8-321 RF)
K770806 · GQX
Flow Laboratories, Inc.
Immunology · 17d
Cleared May 20, 1977
ADENOVIRUS-GROUP FA LABELLED (8-651 RF)
K770807 · GNY
Flow Laboratories, Inc.
Immunology · 17d
Cleared May 20, 1977
RESP. SYNCYTIAL-FA LABELLED PRESERUM
K770808 · GQG
Flow Laboratories, Inc.
Immunology · 17d
Cleared May 20, 1977
MEASLES-FA LABELED PRESERUM (8-441 RNF)
K770809 · GOL
Flow Laboratories, Inc.
Immunology · 17d
Cleared May 20, 1977
VARICELLA-ZOSTER FA LABELED PRESERUM
K770810 · GQX
Flow Laboratories, Inc.
Immunology · 17d
Cleared May 20, 1977
ADENOVIRUS GROUP-FA LABELLED PRESERUM
K770811 · GNY
Flow Laboratories, Inc.
Immunology · 17d
Cleared May 20, 1977
ENDOGATOR
K770813 · EIC
Aus-Tex Dental Mfg. & Design
Dental · 17d
Cleared May 18, 1977
SPLINTS, FINGER/TOE
K770786 · ILH
Depuy, Inc.
Physical Medicine · 16d
Cleared May 18, 1977
AUDIOMETRIC TESTING SYS., SERIES 500
K770823 · EWO
Automated Testing Services, Ltd.
Ear, Nose, Throat · 14d
Cleared May 18, 1977
RECORDING UNIT, MODEL 1445
K770829
Scole Engineering Co.
Cardiovascular · 13d
Cleared May 10, 1977
BILIRUBIN PROCEDURE, TEKPOINT TOT & DIR.
K770458 · CIG
Icn Pharmaceuticals, Inc.
Chemistry · 63d
Cleared May 10, 1977
CANNULA, INTRAVENOUS, TEFLON
K770510 · FOZ
Sherwood Medical Industries
General Hospital · 54d
Cleared May 10, 1977
DIALYZER, FIBER, HOLLOW
K770734 · FJI
Travenol Laboratories, S.A.
Gastroenterology & Urology · 19d
Cleared May 10, 1977
DIALYZER, COIL, CD, LSA, 5M1765
K770735 · FHS
Travenol Laboratories, S.A.
Gastroenterology & Urology · 19d
Cleared May 10, 1977
PORTA CAMERA IIC
K770753 · IYX
General Electric Co.
Radiology · 15d
Cleared May 10, 1977
BAG, URINARY, DRAINAGE, 2D9013
K770762 · KNX
Travenol Laboratories, S.A.
Gastroenterology & Urology · 14d
Cleared May 10, 1977
REGULATOR, PRESSURE, EXPIRATORY
K770766 · BYE
Globe Safety Products, Inc.
Anesthesiology · 12d
Cleared May 10, 1977
FILM PROCESSOR, AUTOMATIC
K770783 · EGY
General Electric Co.
Radiology · 8d
Cleared May 10, 1977
FEEDBACK EDR SYSTEM MODEL EDR-100
K770790 · HCC
Bio-Feedback Systems, Inc.
Neurology · 8d
Cleared May 09, 1977
SH-1
K770344 · CBN
Delta Medical Industries
Anesthesiology · 80d
Cleared May 09, 1977
SMAC SYSTEM
K770508 · JCC
Mid Tech, Inc.
Chemistry · 53d
Cleared May 09, 1977
ECHOCARDIOGRAPHY SYS., MODEL 3830
K770755 · DXK
Honeywell, Inc.
Cardiovascular · 14d
Cleared May 09, 1977
ECHOCARDIOGRAPHY SYS., MODEL 3860
K770756 · DXK
Honeywell, Inc.
Cardiovascular · 14d