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
123121–123144 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 26, 1990
EMIT(R) II 9 CANNABINOID NEGATIVE CALIBRA/CONTROLS
K904569 · DLJ
Syva Co.
Toxicology · 78d
Cleared Dec 26, 1990
EMIT(R) II CANNABINOID 20 NG ASSAY
K904570 · LDJ
Syva Co.
Toxicology · 78d
Cleared Dec 26, 1990
EMIT(R) II CANNABINOID 50 NG ASSAY
K904571 · LDJ
Syva Co.
Toxicology · 78d
Cleared Dec 26, 1990
I/A-PHACO SYSTEM (IRR./ASPIR./AND PHACO./SYSTEM)
K904612 · HQC
Medical Technical Products
Ophthalmic · 76d
Cleared Dec 26, 1990
ACS CHOLESTREROL/TRIGLYCERIDE LIQUID LINEAR CALIBR
K904767 · JIX
Analytical Control Systems, Inc.
Chemistry · 65d
Cleared Dec 26, 1990
GLYC-AFFIN GP
K904814 · LCP
Isolab, Inc.
Chemistry · 63d
Cleared Dec 26, 1990
CEDARS-SINAI QUANTITATIVE TI-201 ANALYSIS CTQ 2.0
K905222 · LLZ
Nuccardiac Software, Inc.
Radiology · 36d
Cleared Dec 26, 1990
CHOLESTECH LIPID MONITORING SYSTEM,HDL CHOLESTEROL
K905296 · LBS
Cholestech Corp.
Chemistry · 29d
Cleared Dec 26, 1990
CHEM-CHEX LIPID
K905389 · JJY
Streck Laboratories, Inc.
Chemistry · 26d
Cleared Dec 26, 1990
CEDIA(R) THEOPHYLLINE ASSAY/MODIFICATION
K905521 · LER
Microgenics Corp.
Toxicology · 19d
Cleared Dec 26, 1990
COULTER DIRECT BILLRUBIN REAGENT
K905622 · CIG
Coulter Electronics, Inc.
Chemistry · 12d
Cleared Dec 24, 1990
SYSTEMS FLOW 2000
K902993 · KPL
Universal Hydrotech, Inc.
Gastroenterology & Urology · 168d
Cleared Dec 24, 1990
EPISENSOR
K903224 · BSP
Palex Intl. SA
Anesthesiology · 154d
Cleared Dec 24, 1990
DEKNATEL MICROFLEX OPHTHALMIC POLYPROPYLENE SUTURE
K903643 · GAW
Deknatel, Inc.
General & Plastic Surgery · 136d
Cleared Dec 24, 1990
PANOSOL II UVA-218
K904426 · FTC
National Biological Corp.
General & Plastic Surgery · 88d
Cleared Dec 24, 1990
PANOSOL II UVB-206
K904427 · FTC
National Biological Corp.
General & Plastic Surgery · 88d
Cleared Dec 24, 1990
PANOSOL II UAB-228
K904428 · FTC
National Biological Corp.
General & Plastic Surgery · 88d
Cleared Dec 24, 1990
SUMMIT TECH 19/20 GAUGE OPHTHALMIC FIBERENDOSCOPE
K904470 · EQH
Summit Technology, Inc.
Ear, Nose, Throat · 84d
Cleared Dec 24, 1990
AUTO SUTURE(R) MODIFIED ENDOSCOPIC LIGATING LOOP
K904588 · GAL
United States Surgical, A Division of...
General & Plastic Surgery · 89d
Cleared Dec 24, 1990
SHARPOINT POLYPROPYLENE NONABSORB SURG SUTURES USP
K904906 · GAW
Chathamborough Research Group, Inc.
General & Plastic Surgery · 60d
Cleared Dec 24, 1990
MODEL 2001, MODIFICATION
K905029 · FRN
Medfusion, Inc.
General Hospital · 54d
Cleared Dec 24, 1990
WILL-CERAM Y AND WILL -CERAM Y-1
K905323 · EJT
Ivoclar North America, Inc.
Dental · 26d
Cleared Dec 24, 1990
WILL-CERAM W-1
K905324 · EJT
Ivoclar North America, Inc.
Dental · 26d
Cleared Dec 24, 1990
MINIGOLD
K905326 · EJT
Ivoclar North America, Inc.
Dental · 26d