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
173401–173424 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 03, 1977
CREATININE PROCEDURE, TEKPOINT
K770454 · CGX
Icn Pharmaceuticals, Inc.
Chemistry · 56d
Cleared May 03, 1977
GLUCOSE PROCEDURE, TEKPOINT DIRECT
K770455 · CGE
Icn Pharmaceuticals, Inc.
Chemistry · 56d
Cleared May 03, 1977
PHOSPHOROUS, INORGANIC, TEKPOINT DIRECT
K770456 · CEO
Icn Pharmaceuticals, Inc.
Chemistry · 56d
Cleared May 03, 1977
CHOLESTEROL PROCEDURE, TEKPOINT TOTAL
K770457 · CGO
Icn Pharmaceuticals, Inc.
Chemistry · 56d
Cleared May 03, 1977
LAS-R TM HUMAN COMPLEMENT C4 TEST
K770547 · DAK
Hyland Therapeutic Div., Travenol...
Immunology · 43d
Cleared May 03, 1977
TUBING FEEDING KIT
K770620 · FPD
Doyle Pharmaceutical
Gastroenterology & Urology · 32d