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

Filters: Cleared only ×
176,076 results
167449–167472 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 14, 1980
INTRAVENOUS INFUSION PUMP, CODE 2M8015
K800629 · FRN
Travenol Laboratories, S.A.
General Hospital · 55d
Cleared May 14, 1980
ORBITOR
K800639 · JAA
Philips Medical Systems (Cleveland),...
Radiology · 51d
Cleared May 14, 1980
MODEL E03 ECHO-OPTHALMOSCOPE
K800652 · IYO
Kt Medical, Inc.
Radiology · 51d
Cleared May 14, 1980
FERRITIRON KIT CAT. #RP-1100
K800710 · JQG
Ria Products, Inc.
Immunology · 44d
Cleared May 14, 1980
MICRO-COIL 100 COIL DIALYZER
K800723 · FHS
Erika, Inc.
Gastroenterology & Urology · 43d
Cleared May 14, 1980
ELEV. BACK SUPPORT W/ADJ. ARM POSITIONER
K800759 · IYE
Radiation Products Design, Inc.
Radiology · 40d
Cleared May 14, 1980
POINT TO POINT LEVEL
K800761 · IYE
Radiation Products Design, Inc.
Radiology · 40d
Cleared May 14, 1980
PS3 TITANIUM SCREW DENTAL IMPLANT
K800762 · DZE
Colmed, Ltd.
Dental · 37d
Cleared May 14, 1980
MOD. DM-357 BICARBONATE RETROFIT KIT
K800772 · FKR
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 37d
Cleared May 14, 1980
TAMPAX TAMPONS
K800777 · HEB
Tampax, Inc.
Obstetrics & Gynecology · 36d
Cleared May 14, 1980
SIREGRAPH C
K800788 · KPR
Siemens Medical Solutions USA, Inc.
Radiology · 36d
Cleared May 14, 1980
TENNIS RACKET-TABLE INSERT PANEL
K800790 · IYE
Radiation Products Design, Inc.
Radiology · 36d
Cleared May 14, 1980
MYLAR WINDOW-TABLE INSERT PANEL
K800791 · IYE
Radiation Products Design, Inc.
Radiology · 36d
Cleared May 14, 1980
ADJUSTABLE HEAD & FACE HOLDER
K800792 · IYE
Radiation Products Design, Inc.
Radiology · 36d
Cleared May 14, 1980
MODEL SKI-200 ABDOMINAL SCANNER
K800824 · IYO
Smithkline Diagnostics, Inc.
Radiology · 30d
Cleared May 14, 1980
EXTENSION SET QUEST CODE #3000
K800825 · FPK
Quest Medical, Inc.
General Hospital · 30d
Cleared May 14, 1980
VABRA ASPIRATOR
K800833 · HHI
Cooper Medical Devices Corp.
Obstetrics & Gynecology · 30d
Cleared May 14, 1980
FETAL HEART DETECTOR #'S D102 & D102R
K800858 · KNG
Sonicaid, Inc.
Obstetrics & Gynecology · 29d
Cleared May 14, 1980
FETAL HEART DETECTOR #D206
K800859 · KNG
Sonicaid, Inc.
Obstetrics & Gynecology · 29d
Cleared May 14, 1980
PLASTIC TUBING ADAPTERS 5-IN-1-
K800880 · DTL
Harvard Laboratories
Cardiovascular · 27d
Cleared May 14, 1980
NUCLEAR STRESS TABLE (NST-1)
K800892 · ISD
Technicare Corp.
Physical Medicine · 26d
Cleared May 14, 1980
GYNECOLOGICAL CYSTO/URETHROSCOPE
K800913 · FGC
Kli
Gastroenterology & Urology · 23d
Cleared May 14, 1980
NORDICLAB ESTRADIOL RIA TEST
K800920 · CHP
Nordiclab Intl.
Chemistry · 23d
Cleared May 14, 1980
NORDICLAB TESTOSTERONE RIA TEST
K800921 · CDZ
Nordiclab Intl.
Chemistry · 23d