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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
87049–87072 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 23, 1998
SOLARTEC SOURCE 270, MODEL # 90123
K983714 · FFS
Cogent Light Technologies, Inc.
Gastroenterology & Urology · 63d
Cleared Dec 23, 1998
VITALCARE DISPOSABLE VAGINAL SPECULUM
K983716 · HIB
Vitalcare Group, Inc.
Obstetrics & Gynecology · 63d
Cleared Dec 23, 1998
SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2
K984014 · JIX
Beckman Coulter, Inc.
Chemistry · 42d
Cleared Dec 23, 1998
POWDER-FREE, LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN CONTENT LABELLING...
K984019 · LYY
Kossan Latex Industries(M)Sdn Bhd
General Hospital · 41d
Cleared Dec 23, 1998
POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (150...
K984020 · LYY
Kossan Latex Industries(M)Sdn Bhd
General Hospital · 41d
Cleared Dec 23, 1998
OLYMPUS MYOGLOBIN IMMUNOTURBIDMETRIC REAGENT
K984145 · DDR
Olympus Diagnostica GmbH
Immunology · 34d
Cleared Dec 23, 1998
MEDSCAND DISPOSABLE PLASTIC VAGINAL SPECULUM
K984211 · HIB
Medscand AB
Obstetrics & Gynecology · 29d
Cleared Dec 23, 1998
AIA-PACK TROPONIN I ASSAY
K984359 · MMI
Tosoh Medics, Inc.
Chemistry · 16d
Cleared Dec 23, 1998
6.8/7.3 BUFFER PACK-MODEL A473-496, WASH SOLUTION PACK-MODEL A73-497
K984384 · CHL
Thermo Bioanalysis Corp.
Chemistry · 15d
Cleared Dec 23, 1998
CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM
K984500 · DYB
Cordis Corp.
Cardiovascular · 6d
Cleared Dec 22, 1998
PHUSIS ABSORBABLE INTERFERENCE SCREW
K970829 · HWC
Tornier
Orthopedic · 656d
Cleared Dec 22, 1998
LS SERIES 200 FLOVISION SYSTEM
K971981 · CAF
Systam
Anesthesiology · 572d
Cleared Dec 22, 1998
CROSSLAPS ELISA
K972788 · JMM
Devices and Diagnostics Consulting Group
Chemistry · 512d
Cleared Dec 22, 1998
LIGHT DIAGNOSTICS RABIES DFA REAGENT
K972975 · GOI
Light Diagnostics
Microbiology · 498d
Cleared Dec 22, 1998
SUMMIT KRUMEICH-BARRAQUER MICROKERATOME
K980675 · HNO
Summit Technology, Inc.
Ophthalmic · 305d
Cleared Dec 22, 1998
ONE STEP URINE DRUG OF ABUSE: PHENCYCLIDINE (PCP) TEST
K981363 · LCM
Tcpi, Inc.
Toxicology · 251d
Cleared Dec 22, 1998
MICRATOME MS7000 -ADVANCED CORNEAL/REFRACTIVE INSTRUMENTATION (ACRI)
K981554 · HNO
Micra Instruments , Ltd.
Ophthalmic · 235d
Cleared Dec 22, 1998
OPTICOAT T3 EIA KIT
K981824 · CDP
Biotecx Laboratories, Inc.
Chemistry · 214d
Cleared Dec 22, 1998
CS/3 COMPACT AIRWAY MODULE, M-COVX
K982091 · MHX
Datex-Engstrom, Inc.
Cardiovascular · 190d
Cleared Dec 22, 1998
DURASOFT 3 UV (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC CONTAC LENSES,...
K982344 · LPL
Wesley Jessen Corp.
Ophthalmic · 169d
Cleared Dec 22, 1998
REAADS IGA ANTI-B2GP 1 TEST KIT
K982434 · MSV
Corgenix, Inc.
Immunology · 161d
Cleared Dec 22, 1998
TYPE 3 FEMORAL COMPONENTS
K983404 · LZO
Howmedica Corp.
Orthopedic · 85d
Cleared Dec 22, 1998
SUPER PORCELAIN STAIN- PURE WHITE
K983470 · EIH
Noritake Co., Inc.
Dental · 82d
Cleared Dec 22, 1998
SUPER SEAL
K983477 · EJK
Phoenix Dental, Inc.
Dental · 81d