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
174241–174264 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 06, 1977
COUNTER, SPONGE
K770698
Devon Industries, Inc.
General & Plastic Surgery · 21d
Cleared May 06, 1977
CATHETER, IRRIGATION
K770706 · GBX
Mallinckrodt Critical Care
General & Plastic Surgery · 18d
Cleared May 06, 1977
MONITOR, PORTABLE, PATIENT, G.E.
K770760 · DPS
General Electric Co.
Cardiovascular · 11d
Cleared May 06, 1977
OPHTHALMOSCOPE, MODEL #11100
K770768 · HLI
Welch Allyn, Inc.
Ophthalmic · 8d
Cleared May 06, 1977
FIBERSCOPIC SCOPE RECORDER SYSTEM
K770782 · GWK
Elmed, Inc.
Neurology · 4d
Cleared May 06, 1977
ECHOENCEPHALOGRAPH, DIGITAL,DIGIECHO2000
K770788 · GXW
Storz Instrument Co.
Neurology · 4d
Cleared May 06, 1977
SUTURE REMOVAL SET, STERILE
K770794 · KDC
Lukens Corp.
General & Plastic Surgery · 4d
Cleared May 06, 1977
BLADES, SURGICAL, STERILE
K770798 · GES
Lukens Corp.
General & Plastic Surgery · 4d
Cleared May 06, 1977
HANDLES, BLADE, SURGICAL
K770800 · GES
Lukens Corp.
General & Plastic Surgery · 4d
Cleared May 06, 1977
PUMP, BALLOON, INTRA-AORTIC, TRI-SEGMENT
K770821 · DSP
Avco Medical Products
Cardiovascular · 2d
Cleared May 04, 1977
DIGITAL THERMOMETER
K761255 · FLL
Texas Instruments, Inc.
General Hospital · 141d
Cleared May 03, 1977
PSORALITE
K761179 · FTC
Ultralite
General & Plastic Surgery · 152d
Cleared May 03, 1977
URINALYSIS PROFICIENCY
K770390 · JJW
Miles Laboratories, Inc.
Chemistry · 64d
Cleared May 03, 1977
CALCIUM PROCEDURE, TEKPOINT DIRECT
K770449 · CIC
Icn Pharmaceuticals, Inc.
Chemistry · 56d
Cleared May 03, 1977
CHLORIDE PROCEDURE, TEKPOINT DIRECT
K770450 · CHJ
Icn Pharmaceuticals, Inc.
Chemistry · 56d
Cleared May 03, 1977
ALBUMIN PROCEDURE, TEKPOINT BROMCRESOL
K770451 · CIX
Icn Pharmaceuticals, Inc.
Chemistry · 56d
Cleared May 03, 1977
PROTEIN PROCEDURE, TEKPOINT TOTAL
K770452 · CEK
Icn Pharmaceuticals, Inc.
Chemistry · 56d
Cleared May 03, 1977
PHOSPHATASE PROCEDURE, TEKPOINT ALKALINE
K770453 · CIO
Icn Pharmaceuticals, Inc.
Chemistry · 56d