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
165601–165624 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 26, 1980
SCANLAN STERNUM NEEDLE-SUTURE
K801976 · GAB
Scanlan Intl., Inc.
General & Plastic Surgery · 38d
Cleared Sep 26, 1980
PROGRAMALITH #'S 221, 222, 221A & 222A
K801978 · DXY
Pacesetter Systems
Cardiovascular · 38d
Cleared Sep 26, 1980
NORDICLAB PROSTATIC ACID PHOSPHATASE RIA
K801988 · JFH
Nordiclab Intl.
Chemistry · 38d
Cleared Sep 26, 1980
PEDIWET=GUAZE IMPREGNATED WITH PETROL
K802007 · FRQ
Pollak (Intl.), Ltd.
Gastroenterology & Urology · 37d
Cleared Sep 26, 1980
BALLOON RETENTION CHEST CATHETER
K802025 · GBA
Loseff Medical Designers, Ltd.
General & Plastic Surgery · 37d
Cleared Sep 26, 1980
IMPLANTABLE VENTRICULAR-INHIB. C.P. GEN
K802028 · DXY
Telectronics, Inc.
Cardiovascular · 36d
Cleared Sep 26, 1980
OXFORD INTENSIVE CARE PATIENT MON. SYS
K802033 · DSI
Oxford Medilog, Inc.
Cardiovascular · 35d
Cleared Sep 26, 1980
BAKER DIAG. ULTRARATE CO2 REAGENT KIT
K802035 · JFL
J.T. Baker Chemical Co.
Chemistry · 35d
Cleared Sep 26, 1980
RIONET HEARING AID HB-69C
K802053 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 32d
Cleared Sep 26, 1980
DATA-ZYME UREA NITROGEN REAGENT SET
K802061 · CDQ
Data Medical Associates, Inc.
Chemistry · 32d
Cleared Sep 26, 1980
DUPONT ACALACTIC ACID (LA) TEST
K802064 · KHP
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 30d
Cleared Sep 26, 1980
CLEAN-AIR POLLUTION REDUCTION SYSTEM
K802067 · CBN
Porter Instrument Co., Inc.
Anesthesiology · 30d
Cleared Sep 26, 1980
PROT-A-TRAC
K802072 · HST
Robert I. Branick, M.D.
Neurology · 30d
Cleared Sep 26, 1980
STIFF STYLETS
K802076 · DRB
Cardiac Pacemakers, Inc.
Cardiovascular · 29d
Cleared Sep 26, 1980
AULD BAGGER KIT
K802081 · BTM
Modern Medical Systems Co.
Anesthesiology · 29d
Cleared Sep 26, 1980
CARDIOTRAK
K802089 · DXH
Cardiac Pacemakers, Inc.
Cardiovascular · 24d
Cleared Sep 26, 1980
DRAGER PRESSURE MONITOR, SELF-DIAGNOSTIC
K802090 · CAP
Draeger Medical, Inc.
Anesthesiology · 24d
Cleared Sep 26, 1980
GABBAY-FRATER SUTURE GUIDE
K802093 · FZX
Howmedica Corp.
General & Plastic Surgery · 24d
Cleared Sep 26, 1980
ECG RECALL & EDIT PRODUCT VERSION-A3601
K802103 · DSI
General Electric Co.
Cardiovascular · 23d
Cleared Sep 26, 1980
FIBRI QUIK
K802117 · GJA
General Diagnostics
Hematology · 22d
Cleared Sep 26, 1980
ISOLETTE INCUBATOR C-100
K802126 · FMZ
Narco Air-Shields
General Hospital · 22d
Cleared Sep 26, 1980
IMMUNODIFFUSSION REAGENTS/SEROLOGICAL
K802128 · JWW
Nolan Biological Laboratories, Inc.
Microbiology · 53d
Cleared Sep 26, 1980
IMMUNODIFFUSION REAGENTS/SEROLOGICAL
K802129 · GMI
Nolan Biological Laboratories, Inc.
Microbiology · 53d
Cleared Sep 26, 1980
IMMUNO. IDENTIFICATION OF H. CAPSULATUM
K802130 · GMJ
Nolan Biological Laboratories, Inc.
Microbiology · 53d