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
134761–134784 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jul 08, 1988
COOL EYE(TM) EYE PROTECTOR
K881135 · HOY
Cool Eyes, Inc.
Ophthalmic · 114d
Cleared Jul 08, 1988
BLOOD PH CAPILLARY TUBES, HEPARIN
K881188 · CHL
Helps Products, Inc.
Chemistry · 109d
Cleared Jul 08, 1988
X-RAY GENERATING SYSTEM TF 1000
K881386 · IZO
General Medical Merate S.P.A
Radiology · 98d
Cleared Jul 08, 1988
X-RAY GENERATING SYSTEM, TF 800
K881387 · IZO
Absolute X-Ray Corp.
Radiology · 98d
Cleared Jul 08, 1988
LIQUI-SERA SERUM ALCOHOL CONTROLS
K881430 · JJX
Biodiagnostic Intl
Toxicology · 94d
Cleared Jul 08, 1988
MODIFIED DADE COMPRE. ELECTROPHORESIS CONTROL
K881503 · JJY
Baxter Healthcare Corp
Chemistry · 88d
Cleared Jul 08, 1988
SITZMARKS
K881609 · FFX
Lafayette Pharmacal, Inc.
Gastroenterology & Urology · 87d
Cleared Jul 08, 1988
4000/4900/6000/8000/8900 YAG, & 1700 YAG/CO2 LASER
K881619 · GEX
Heraeus Lasersonics, Inc.
General & Plastic Surgery · 86d
Cleared Jul 08, 1988
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (PROT)
K881639 · CEK
Eastman Kodak Company
Chemistry · 85d
Cleared Jul 08, 1988
ACCI-GUARD MULTI-SAMPLE BLOOD COLLECTION NEEDLE
K881654 · FMI
Medical Safety Products, Inc.
General Hospital · 84d
Cleared Jul 08, 1988
CIBA CORNING MAGIC LITE DIGOXIN IMMUNOASSAY
K881679 · DON
Ciba Corning Diagnostics Corp.
Chemistry · 80d
Cleared Jul 08, 1988
LINDLEY II RESUSCITATOR
K881689 · BYT
Lindley Resuscitator, Inc.
Anesthesiology · 80d
Cleared Jul 08, 1988
DIDECO-SHILEY FLUID COLLECTION BAG
K881692 · CAC
Shiley, Inc.
Anesthesiology · 80d
Cleared Jul 08, 1988
IMMUNOCARD(TM) HCG II TEST KIT
K881709 · JHI
Disease Detection International, Inc.
Chemistry · 79d