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
124993–125016 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 12, 1990
ESPI NON-INSULATED DOUBLE-ACTION GRASPER, #8203
K903602 · HET
Dixon Medical, Inc.
Obstetrics & Gynecology · 35d
Cleared Sep 12, 1990
GENESIS INSUFFLATING CATHETER
K903669 · BSY
General Medical Co.
Anesthesiology · 30d
Cleared Sep 12, 1990
OLYMPUS INORGANIC PHOSPHORUS
K903696 · CEO
Em Diagnostic Systems, Inc.
Chemistry · 28d
Cleared Sep 12, 1990
PHYSICIAN'S CHOICE
K903744 · HIB
Advance Medical Device, Inc.
Obstetrics & Gynecology · 27d
Cleared Sep 12, 1990
SYVA MICROTRAK EIA ACCESSORY REAGENTS
K903758 · LJC
Syva Co.
Microbiology · 23d
Cleared Sep 12, 1990
ARGIBOND DENTAL ALLOY FOR PORCELAIN
K903818 · EJT
Argen Precious Metals, Inc.
Dental · 23d
Cleared Sep 12, 1990
ARGISTAR 45 GOLD ALLOY FOR PORCELAIN
K903819 · EJT
Argen Precious Metals, Inc.
Dental · 23d
Cleared Sep 12, 1990
NOVABOND GOLD ALLOY FOR PORCELAIN
K903830 · EJT
Argen Precious Metals, Inc.
Dental · 22d
Cleared Sep 12, 1990
ARGICRAFT 1 PALLADIUM SILVER ALLOY FOR PORCELAIN
K903831 · EJT
Argen Precious Metals, Inc.
Dental · 22d
Cleared Sep 12, 1990
ARGICRAFT 2 PALLADIUM SILVER ALLOY FOR PORCELAIN
K903832 · EJT
Argen Precious Metals, Inc.
Dental · 22d
Cleared Sep 12, 1990
DENTABOND GOLD ALLOY FOR PORCELAIN
K903833 · EJT
Argen Precious Metals, Inc.
Dental · 22d
Cleared Sep 12, 1990
WET-NO-MORE MONITOR
K903856 · KPN
Travis Industries, Inc.
Gastroenterology & Urology · 50d
Cleared Sep 11, 1990
OPTIMATE HEMOGLOBIN A1C
K896830 · LCP
Heraeus Kulzer, Inc.
Hematology · 281d
Cleared Sep 11, 1990
OXIMETRY PROBE CATHETERS
K901736 · DQE
Baxter Healthcare Corp
Cardiovascular · 147d
Cleared Sep 11, 1990
PERSONAL 120/210 BASIC ELECTROCARDIOGRAPH
K902368 · DPS
Esaote Biomedica Spa
Cardiovascular · 105d
Cleared Sep 11, 1990
ADG BONE PLUG
K902615 · LZN
American Design Group, Inc.
Orthopedic · 90d
Cleared Sep 11, 1990
SL-SELF LOCKING TOTAL HIP-FEMORAL COMPONENT
K902621 · JDI
Lima Intl. Corp.
Orthopedic · 89d
Cleared Sep 11, 1990
MODULE 486 VARIABLE WAVELENGTH TUNABLE UV/VIS DETE
K903647 · LDM
Millipore Corp.
Chemistry · 33d
Cleared Sep 10, 1990
MODIFIED LYOFOAM WOUND DRESSINGS
K895764 · KMF
Acme United Corp.
General & Plastic Surgery · 349d
Cleared Sep 10, 1990
TIPSTOP(TM)
K896068 · KGX
Gambro-Hospal, Inc.
General & Plastic Surgery · 326d
Cleared Sep 10, 1990
ENDOBRUSH(TM) DEVICE
K897070 · HFE
Intl. Cytobrush, Inc.
Obstetrics & Gynecology · 262d
Cleared Sep 10, 1990
NIDEK MODEL AKC-8000 OPHTHALMIC LASER PHOTOCOAGULA
K900890 · GEX
Nidek, Inc.
General & Plastic Surgery · 195d
Cleared Sep 10, 1990
NIDEK, INC. MODEL ADC-8000 DERM
K900925 · GEX
Nidek, Inc.
General & Plastic Surgery · 195d
Cleared Sep 10, 1990
LASERCOMP MODEL STAR 10 FOR KNEE ARTHROSCOPY
K901127 · GEX
Lasercomp
General & Plastic Surgery · 182d