FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
123865–123888 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 14, 1990
MRT 35-A (TM)
K905441 · LNH
Toshiba America Mri, Inc.
Radiology · 80d
Cleared Dec 13, 1990
PHOENIX LASER SYSTEMS OPHTHALMIC SURGICAL WORKSTA.
K901605 · LXS
Phoenix Laser Systems, Inc.
Ophthalmic · 252d
Cleared Dec 13, 1990
ANGEFLATOR(TM)
K902377 · DXT
Angeion Corp.
Cardiovascular · 197d
Cleared Dec 13, 1990
ARTERIAL BLOOD FILTER ELECTRO. AIR* STAR 40 AND 20
K902723 · DTM
Electromedics, Inc.
Cardiovascular · 177d
Cleared Dec 13, 1990
SODIUM CHLORIDE SOLUTION
K903347 · FOZ
Superior Healthcare Group, Inc.
General Hospital · 141d
Cleared Dec 13, 1990
QUALTURE
K903470 · JXA
Future Medical Technologies Intl., Inc.
Microbiology · 134d
Cleared Dec 13, 1990
INTERTECH(TM) HEAT AND MOISTURE EXCHANGER
K903519 · BYD
Intertech Resources, Inc.
Anesthesiology · 132d
Cleared Dec 13, 1990
WRP FOLEYCATH
K903777 · EZL
Wembley Rubber Products (M) Sdn Bhd
Gastroenterology & Urology · 115d
Cleared Dec 13, 1990
NAPHTHOL AS-D CHLOR/A-NAPHTHYL ACET ESTERASE KIT
K903995 · GHD
Sigma Chemical Co.
Pathology · 106d
Cleared Dec 13, 1990
PULMOVISION CHEST RADIOGRAPHY X-RAY SYSTEM
K904144 · IZP
Mallinckrodt Group, Inc.
Radiology · 97d
Cleared Dec 13, 1990
HYDRA VISION UROLOGICAL X-RAY SYSTEM
K904145 · KPR
Mallinckrodt Group, Inc.
Radiology · 97d
Cleared Dec 13, 1990
NEURO VISION RADIOGRAPHIC X-RAY SYSTEM
K904146 · KPR
Mallinckrodt Group, Inc.
Radiology · 97d
Cleared Dec 13, 1990
HUGH YOUNG II UROLOGICAL X-RAY SYSTEM
K904147 · KPR
Mallinckrodt Group, Inc.
Radiology · 97d
Cleared Dec 13, 1990
PATHODX HERPES TYPING
K904167 · GQL
Diagnostic Products Corp.
Microbiology · 93d
Cleared Dec 13, 1990
MINNOW PENILE IMPLANT PROTECTOR
K904262 · FAE
Ruja-Med Medical Marketing
Gastroenterology & Urology · 90d
Cleared Dec 13, 1990
CO2 LASERS AND INFRAGUIDE DELIVERY SYSTEM
K904423 · GEX
Heraeus Lasersonics, Inc.
General & Plastic Surgery · 77d
Cleared Dec 13, 1990
MODELS 4000,4900,6000,8000,8900, LUXUS 6&100/1700
K904444 · GEX
Heraeus Lasersonics, Inc.
General & Plastic Surgery · 76d
Cleared Dec 13, 1990
ACTIVE ADAPTER
K904506 · GEI
Beacon Laboratories, Inc.
General & Plastic Surgery · 72d
Cleared Dec 13, 1990
ABL510 BLOOD GAS SYSTEM
K904513 · CHL
Radiometer America, Inc.
Chemistry · 72d
Cleared Dec 13, 1990
QUALTEX SKIN MARKER
K904559 · FZZ
Qualtex, Inc.
General & Plastic Surgery · 69d
Cleared Dec 13, 1990
DSL CK-MB (DSL #3200)
K904721 · JHT
Diagnostic Systems Laboratories, Inc.
Toxicology · 56d
Cleared Dec 13, 1990
CARDIOFAX ECG-8830A
K904758 · DPS
Nihon Kohden America, Inc.
Cardiovascular · 55d
Cleared Dec 13, 1990
ABUSCREEN ONTRAK FOR THC
K904856 · LDJ
Roche Diagnostic Systems, Inc.
Toxicology · 45d
Cleared Dec 13, 1990
COULTER CK-MB ISOENZYME REAGENT
K904866 · JHT
Coulter Electronics, Inc.
Chemistry · 45d