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
173377–173400 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 09, 1977
PULSE/PHONOCARDIOGRAPHY CHANNEL, 144
K770757 · DQC
Honeywell, Inc.
Cardiovascular · 14d
Cleared May 06, 1977
EXAM GOWN
K770476 · FME
General Medical Co.
General Hospital · 56d
Cleared May 06, 1977
IN VITRO DIAGNOSTIC REAGENTS
K770506 · JJC
Norwood Scientific Associates, Inc.
Chemistry · 51d
Cleared May 06, 1977
LENS, CONTACT, HARD
K770582 · HPX
Berea Contact Lens, Inc.
Ophthalmic · 39d
Cleared May 06, 1977
ANALYZEO, PLASMA, BLOOD, COLYSAGRAPH
K770606 · JPA
Damon Corp.
Hematology · 36d
Cleared May 06, 1977
HEMALOG 8/90
K770666 · GKL
Technicon Instruments Corp.
Hematology · 28d