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
142849–142872 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 11, 1986
SCHNEIDER-SHILEY SELDINGER INITIAL PUNCTURE INSTR
K862467 · LIT
Shiley, Inc.
Cardiovascular · 42d
Cleared Aug 11, 1986
BAUSCH & LOMB CONTACT LENS VIEWER
K862517 · HLF
Bausch & Lomb, Inc.
Ophthalmic · 41d
Cleared Aug 11, 1986
BAUSCH & LOMB VERTOMETER V-5
K862518 · HLM
Bausch & Lomb, Inc.
Ophthalmic · 41d
Cleared Aug 11, 1986
DEKNATEL (R) TREPHINE
K862524 · HRH
Deknatel, Inc.
Ophthalmic · 40d
Cleared Aug 11, 1986
TUBING CONNECTOR #10-810-60 100/PKG NON-STERILE
K862722 · FKY
Mercury Enterprises, Inc.
Gastroenterology & Urology · 25d
Cleared Aug 11, 1986
MODEL A-8000 ULTRASONIC HANDPIECE CORD
K862777 · HQC
Advanced Medical Technology, Inc.
Ophthalmic · 20d
Cleared Aug 11, 1986
SPUNGUARD HOSPITAL COVERALL
K862804
Kimberly-Clark Corp.
General & Plastic Surgery · 20d
Cleared Aug 11, 1986
MICRO-AIRE REPLACE OTOLOGY BURS/ZIM HALL SUR INSTR
K862852 · GFF
Micro-Aire Surgical Instruments, Inc.
General & Plastic Surgery · 13d
Cleared Aug 08, 1986
NEOS VS-1, PULSE GENERATOR
K860921 · DXY
Biotronik Sales, Inc.
Cardiovascular · 150d
Cleared Aug 08, 1986
LA DIFFUSION TECHNIQUE, KTY CM-10 BREAST PUMP
K861513 · HGX
Crystal Medical Products, Inc.
Obstetrics & Gynecology · 107d
Cleared Aug 08, 1986
FIAX TEST KIT FOR MYCOPLASMA PNEUMONIAE-G ANTIBODY
K861716 · GRZ
Whittaker Bioproducts, Inc.
Microbiology · 94d
Cleared Aug 08, 1986
GLUCOFACTS DATA PRINTER
K861779 · JQP
Miles Laboratories, Inc.
Chemistry · 92d
Cleared Aug 08, 1986
POLY-TECH ANGIOGRAPHY CATHETER
K862030 · DQO
Poly-Tech Medical Device Research &...
Cardiovascular · 72d
Cleared Aug 08, 1986
GELMAN ARTERIAL FILTER (43, 33 AND 21 MICRON)
K862068 · DTM
Gelman Sciences, Inc.
Cardiovascular · 70d
Cleared Aug 08, 1986
MODIFIED OSCOR PY PACING LEADS
K862330 · DTB
Oscor Medical Corp.
Cardiovascular · 50d
Cleared Aug 08, 1986
RUBELLA IGM EIA TEST KIT
K862431 · LFX
Labsystems, Inc.
Microbiology · 43d
Cleared Aug 08, 1986
SANDARE GLYCOHEMOGLOBIN PROCEDURE
K862556 · LCP
Sandare Chemical Co., Inc.
Hematology · 36d
Cleared Aug 08, 1986
D.L. SCOPE(R) OTOSCOPE
K862661 · ERA
North American Medical Products, Inc.
Ear, Nose, Throat · 25d
Cleared Aug 08, 1986
AIRCO PRESSURE REGULATORS
K862796 · CAN
Airco, Inc.
Anesthesiology · 17d
Cleared Aug 08, 1986
AIRCO 2000 SERIES FLOWMETERS
K862797 · CAX
Airco, Inc.
Anesthesiology · 17d
Cleared Aug 07, 1986
DERMASCAN LASER SURGICAL HANDPIECE
K860083 · GEX
Medical Laser Research & Development...
General & Plastic Surgery · 210d
Cleared Aug 07, 1986
WALLANT NEUROLOGIX GENERAL PURPOSE TENS
K860847 · GZJ
Wallant Intl. Trade, Inc.
Neurology · 154d
Cleared Aug 07, 1986
ENDOSCOPIC ELECTROSURGICAL FIBEROPTIC PROBE
K861331 · LNK
Trimedyne, Inc.
Gastroenterology & Urology · 120d
Cleared Aug 07, 1986
SCHURMAN/CARTER HIP PROSTHESIS POROUS COATED
K861450
Kirschner Medical Corp.
Orthopedic · 111d