FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
135337–135360 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 12, 1988
EMIT HVA COCAINE METABOLITE ASSAY
K881942 · DIO
Syva Co.
Toxicology · 64d
Cleared Jul 12, 1988
ESCORT - PORTABLE PATIENT MONITOR
K881986 · DXH
Medical Data Electronics
Cardiovascular · 61d
Cleared Jul 12, 1988
HARMONY HEARING AID MODELS LP, M, HO, HF, & C
K882005 · ESD
Harmony Hearing Aids, Co.
Ear, Nose, Throat · 60d
Cleared Jul 12, 1988
HIGH TORQUE TEMPORARY PERVENOUS LEAD W/DEPTH MARK
K882045 · LDF
Cordis Leads, Inc.
Cardiovascular · 57d
Cleared Jul 12, 1988
ACUCAIR CUSHION CONTINUOUS AIRFLOW SYSTEM
K882161 · FNM
Ssi Medical Services, Inc.
General Hospital · 50d
Cleared Jul 12, 1988
EMIT HVA PHENCYCLIDINE ASSAY
K882179 · LCL
Syva Co.
Toxicology · 49d
Cleared Jul 12, 1988
SYSMEX QUICKLYSER-II (QLS-200A)
K882267 · GIF
Toa Medical Electronics USA, Inc.
Hematology · 42d
Cleared Jul 12, 1988
SCEPTOR ENTERIC MIC PANEL (REVISED 4/88)
K882300 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 40d
Cleared Jul 12, 1988
SCEPTOR ENTERIC MIC/ID PANEL (REVISED 4/88)
K882301 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 40d
Cleared Jul 12, 1988
IVAC(R) UNVENTED VOL. INFUSION SET MODEL 52080
K882302 · FPA
Y
General Hospital · 40d
Cleared Jul 12, 1988
DIGITAL THERMOMETER SHEATHS (ORAL AND RECTAL)
K882304 · FLL
Abco Dealers, Inc.
General Hospital · 39d
Cleared Jul 12, 1988
ACCRAASSAY RID KITS
K882369 · DEW
Icn Immunobiologicals
Immunology · 34d
Cleared Jul 12, 1988
MODIFIED HEART*AID 97 AUTO. EXTERNAL DEFIBRILLATOR
K882513 · DSI
Cardiac Resucitator Corp.
Cardiovascular · 40d
Cleared Jul 12, 1988
ABBOTT TESTPACK(TM) GONORRHEA POSITIVE CONTROL
K882534 · LIR
Abbott Laboratories
Microbiology · 21d
Cleared Jul 12, 1988
TECNOL CATHETER LEG STRAP
K882641 · KNY
Tecnol New Jersey Wound Care, Inc.
Gastroenterology & Urology · 15d
Cleared Jul 12, 1988
STAT-20 FLUOROMETER
K882677 · JZT
Weaver Medical
Immunology · 14d
Cleared Jul 11, 1988
CODE #D2020-FINE NEEDLE ASPIRATION BIOPSY SYSTEM
K882105 · GAA
Dianon Systems, Inc.
General & Plastic Surgery · 53d
Cleared Jul 08, 1988
IMMUNOCCULT EIA TEST KIT
K871143 · KHE
Intl. Immunoassay Laboratories, Inc.
Hematology · 473d
Cleared Jul 08, 1988
SL-100 ND:YAG LASER FOR GYNECOLOGY USE
K871512 · GEX
Medical Energy, Inc.
General & Plastic Surgery · 445d
Cleared Jul 08, 1988
ADULT STAR
K872466 · CBK
Infrasonics Corp.
Anesthesiology · 381d
Cleared Jul 08, 1988
DU PONT VCA-IGM ANTIBODY ELISA KIT
K875204 · LJN
E.I. Dupont DE Nemours & Co., Inc.
Microbiology · 203d
Cleared Jul 08, 1988
MODEL MR430 SPECIAL PURPOSE HUMID. HEATER BASES
K880702 · BTT
Fisher & Paykel Allied Products , Ltd.
Anesthesiology · 137d
Cleared Jul 08, 1988
QUANTAI BG(TM) REAGENT STRIP
K880703 · CGA
Quantai Biotronics, Inc.
Chemistry · 137d
Cleared Jul 08, 1988
CONDOM
K881100 · HIS
Glnic Corp.
Obstetrics & Gynecology · 115d