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
120097–120120 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 23, 1991
HUENE FIXATION SCREW
K910193 · HWC
Acu Med, Inc.
Orthopedic · 219d
Cleared Aug 23, 1991
BBL(R) DMACA INDOLE REAGENT DROPPERS
K912480 · JTO
Bd Becton Dickinson Vacutainer...
Microbiology · 81d
Cleared Aug 23, 1991
CONTOUR-PORT
K912540 · LJT
Ideal Medical, Inc.
General Hospital · 74d
Cleared Aug 23, 1991
CURAY SUPPORT
K912788 · EBF
Scientific Pharmaceuticals, Inc.
Dental · 60d
Cleared Aug 23, 1991
IRIS OCULIGHT DIODE LASER ADDING SLIT LAMP ADAPTER
K912918 · GEX
Iriderm Div.
General & Plastic Surgery · 51d
Cleared Aug 23, 1991
MODIFICATION TECNOL FLUIDSHIELD SURGICAL MASKS
K913043 · FXX
Tecnol New Jersey Wound Care, Inc.
General Hospital · 64d
Cleared Aug 23, 1991
V-ACCI-GUARD(TM) REUSABLE HOLDER
K913329 · FMI
Medical Safety Products, Inc.
General Hospital · 29d
Cleared Aug 23, 1991
DYNEX IIIB, MODEL 89002026
K913594 · GZJ
Medtronic Vascular
Neurology · 10d
Cleared Aug 22, 1991
GAP-IGG
K900343 · LYR
Biomerica, Inc.
Microbiology · 576d
Cleared Aug 22, 1991
BIOCHEM TEMPERATURE/ FIO2 MODULE
K910381 · CCL
Biochem International, Inc.
Anesthesiology · 205d
Cleared Aug 22, 1991
TITANIUM CATHETER EXTENDER
K910785 · FJS
Accurate Surgical Instruments Co.
Gastroenterology & Urology · 178d
Cleared Aug 22, 1991
MONARCH SYSTEM
K911051 · MHX
Baxter Healthcare Corp
Cardiovascular · 167d
Cleared Aug 22, 1991
BIOCHEM 9100 MULTIGAS MONITOR TEMP/FIO1 MOD,NIBP
K911351 · DXN
Biochem International, Inc.
Cardiovascular · 148d
Cleared Aug 22, 1991
ROCKET REFERENCE PLASMA, CAT. NO. 5188, MODIFIED
K911777 · GGN
Helena Laboratories
Hematology · 142d
Cleared Aug 22, 1991
SPECTROLYSE PLASMINOGEN SK KIT
K912025 · GGP
Biopool AB
Hematology · 107d
Cleared Aug 22, 1991
VENETO COLLECTION
K912034 · HQZ
Atlantic Optical Co., Inc.
Ophthalmic · 106d
Cleared Aug 22, 1991
CPAP SYSTEM AND BRONCHO-CATH W/CPAP SYSTEM
K912240 · BYE
Mallinckrodt Anesthesia Products
Anesthesiology · 93d
Cleared Aug 22, 1991
SCHNEIDER MONORAIL 421 PERCU TRANS ANGIO PTA CATH
K912317 · LIT
Schneider Intl., Ltd.
Cardiovascular · 90d
Cleared Aug 22, 1991
DAVIS & GECK CHROMIC & PLAIN GUT LIGATURE CARRIER
K912319 · GCJ
Davis & Geck, Inc.
General & Plastic Surgery · 90d
Cleared Aug 22, 1991
BIOPHYSIOMETER POSITIONING CHAIR
K912320 · INO
Bi-Dynamics, Inc.
Physical Medicine · 90d
Cleared Aug 22, 1991
GENTAMICIN 500 UG/ML TO BE INCLUDED IN JUSTONE(TM)
K912613 · JWY
Sensititre Microbiology A Div. of...
Microbiology · 71d
Cleared Aug 22, 1991
ARACHIDONIC ACID
K912774 · JBX
Helena Laboratories
Hematology · 59d
Cleared Aug 22, 1991
BACTI-SWAB(TM) NPG
K912832 · LIO
Remel Co.
Microbiology · 57d
Cleared Aug 22, 1991
JUSTONE(TM)
K912846 · JWY
Sensititre Microbiology A Div. of...
Microbiology · 71d