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
166609–166632 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 14, 1980
NORDICLAB PROGESTERONE RIA TEST
K800922 · JLS
Nordiclab Intl.
Chemistry · 23d
Cleared May 14, 1980
PAPER-PAK OB PADS
K800952 · HHD
Paper-Pak Products, Inc.
Obstetrics & Gynecology · 21d
Cleared May 14, 1980
LARGE VOLUME ENEMA CONTAINER DISPOSABLE
K800959 · FCE
The Healthcare Group Laboratories, Inc.
Gastroenterology & Urology · 21d
Cleared May 14, 1980
1500 ML DISPOSABLE ENEMA CONTAINER(1110)
K800960 · FCE
The Healthcare Group Laboratories, Inc.
Gastroenterology & Urology · 21d
Cleared May 14, 1980
ENEMA CONTAINER DISP. FOR EMEMA ADMIN.
K800961 · FCE
The Healthcare Group Laboratories, Inc.
Gastroenterology & Urology · 21d
Cleared May 14, 1980
IMMUNOGLOBULIN E TEST KIT
K800995 · DGO
Calbiochem-Behring Corp.
Immunology · 19d