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
124753–124776 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 17, 1990
ASPARTATE AMINOTRANSFERASE TEST
K903197 · CIT
Em Diagnostic Systems, Inc.
Chemistry · 29d
Cleared Aug 17, 1990
CHALLENGE BRAND LIQUID MULTI-ENZYME LINEARITY CONT
K903225 · JJY
Medical Analysis Systems, Inc.
Chemistry · 25d
Cleared Aug 17, 1990
EMIT ETS PLUS ETHYL ALCOHOL ASSAY
K903228 · DMI
Syva Co.
Toxicology · 25d
Cleared Aug 17, 1990
MODEL 900S APNEA/HEART MONITOR
K903287 · BZQ
Healthdyne, Inc.
Anesthesiology · 37d
Cleared Aug 17, 1990
SYNERMED CREATININE REAGENT KIT
K903296 · CGX
Synermed, Inc.
Chemistry · 24d
Cleared Aug 17, 1990
TEMP MARQ TEMPERATURE TREND INDICATOR
K903307 · KPD
Marquest Medical Products, Inc.
General Hospital · 24d
Cleared Aug 17, 1990
MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K903319 · LNH
GE Medical Systems
Radiology · 23d
Cleared Aug 17, 1990
SYSTEMATE AMYLASE (AMYL) ITEM NUMBER 65404
K903332 · JFJ
Em Diagnostic Systems, Inc.
Chemistry · 23d
Cleared Aug 17, 1990
CREATINE KINASE TEST (CK) ITEM NUMBER 65411
K903333 · CGS
Em Diagnostic Systems, Inc.
Chemistry · 23d
Cleared Aug 17, 1990
SYSTEMATE URIC ACID (URCA) ITEM NUMBER 65422
K903335 · CDO
Em Diagnostic Systems, Inc.
Chemistry · 23d
Cleared Aug 17, 1990
NORTECH MODEL 86901000 ELECTRODE
K903427 · GXY
Andover Medical, Inc.
Neurology · 17d
Cleared Aug 17, 1990
MOD PURITAN BENNETT SING PATIENT DISPOS MAN RESUS
K903438 · BTM
Puritan Bennett Corp.
Anesthesiology · 17d
Cleared Aug 17, 1990
MODIFIED SINGLE PATIENT USE DISP MAN RESUSCITATOR
K903443 · BTM
Puritan Bennett Corp.
Anesthesiology · 17d
Cleared Aug 17, 1990
SURGEON'S (SURGICAL) GLOVES
K903534 · KGO
Straitscom
General Hospital · 11d
Cleared Aug 17, 1990
SINGLE PATIENT USE INFANT DISPOSABLE MANUAL RESUSC
K903570 · BTM
Puritan Bennett Corp.
Anesthesiology · 10d
Cleared Aug 17, 1990
PHARMACIA DELFIA SYSTEM B2-MICRO
K903578 · JZG
Pharmacia, Inc.
Immunology · 9d
Cleared Aug 17, 1990
POWDER FREE, NON-STERILE EXAMINATION GLOVES
K903607 · LYY
Tillotson Rubber Co., Inc.
General Hospital · 10d
Cleared Aug 17, 1990
INFANT MANUAL RESUSCITATOR (PMR 2)
K903631 · BTM
Puritan Bennett Corp.
Anesthesiology · 7d
Cleared Aug 15, 1990
CATHETER WITH GUIDEWIRE ASSEMBLY DEVICE
K900056 · FOZ
Abbott Laboratories
General Hospital · 224d
Cleared Aug 15, 1990
ANTEGRADE/RETROGRADE Y W/INTEGRAL SELECTOR SWIT.
K900994 · DTL
Dlp, Inc.
Cardiovascular · 166d
Cleared Aug 15, 1990
ORTHOSORB(R) ABSORBABLE PIN
K901456 · OVZ
Johnson & Johnson International
Orthopedic · 141d
Cleared Aug 15, 1990
ADD'L TRANSDUCER FOR USE W/THE COMBISON 310A
K901725 · ITX
Kretztechnik AG
Radiology · 121d
Cleared Aug 15, 1990
SUCTION ORA-SWAB(R) BRUSH KIT
K901806 · EIA
Sage Products, Inc.
Dental · 117d
Cleared Aug 15, 1990
O. B. PACK I
K902271 · HHD
Customed, Inc.
Obstetrics & Gynecology · 86d