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
145729–145752 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 17, 1985
OVUTIME OVULATION PREDICTOR TEST
K853142 · CEP
Advanced Care Products
Chemistry · 141d
Cleared Dec 17, 1985
MODIFIED MYDRIATIC SPECTACLE
K854140
La Rue Optical
Ophthalmic · 68d
Cleared Dec 17, 1985
BATTLE CREEK DIGI-TRACKER ELCTRIC TREADMILL
K854148 · IOL
Battle Creek Equipment Co.
Physical Medicine · 67d
Cleared Dec 17, 1985
TIP OFF FORCEPS
K854541 · GEN
Keller Instruments, Inc.
General & Plastic Surgery · 34d
Cleared Dec 17, 1985
HYPODERMIC NEEDLE AND STYLET
K854579 · GAA
Berkley and Co.
General & Plastic Surgery · 32d
Cleared Dec 17, 1985
MALIS MICRO BIPOLAR COAGULATOR
K854592 · GEI
Valley Forge Scientific Corp.
General & Plastic Surgery · 29d
Cleared Dec 17, 1985
SURGICAL BLADES
K854620 · GES
Niraj Industries
General & Plastic Surgery · 29d
Cleared Dec 17, 1985
X-RAY DETECTABLE COTTON BALLS
K854714 · GDY
American Silk Sutures, Inc.
General & Plastic Surgery · 25d
Cleared Dec 17, 1985
SURGICAL INSTRUMENT TRAY
K854746 · FSM
Zbi, Inc.
General & Plastic Surgery · 21d
Cleared Dec 17, 1985
THE CALIFORNIA SPLINT
K854752 · DXQ
Intl. Medication Systems, Ltd.
Cardiovascular · 21d
Cleared Dec 17, 1985
AMERICAN STERILE MAYO STAND TRAY
K854759
American Hospital Supply Corp.
General & Plastic Surgery · 20d
Cleared Dec 16, 1985
SPINAL STABILIZING UNIT
K851864
Counterstress Products, Inc.
Orthopedic · 234d
Cleared Dec 16, 1985
LINK SHOULDER PROSTHESIS ENDO-MODEL SYSTEM
K852365 · KWS
Link America, Inc.
Orthopedic · 195d
Cleared Dec 16, 1985
STORZ IAS DISPOSABLE PACK
K853430 · HQE
Storz Instrument Co.
Ophthalmic · 123d
Cleared Dec 16, 1985
BIOSTAR RE-A-DS IMMUNE COMPLEX ASSAY KIT
K853697 · DAK
Biostar Medical Products, Inc.
Immunology · 103d
Cleared Dec 16, 1985
ALL-IN-ONE HARD CONTACT LENS SOLUTION
K853807 · HPX
Maurry Biological Co.
Ophthalmic · 96d
Cleared Dec 16, 1985
WETTING SOLUTION FOR HARD CONTACT LENSES
K853810 · HPX
Maurry Biological Co.
Ophthalmic · 96d
Cleared Dec 16, 1985
HARD CONTACT LENS SOAKING SOLUTION
K853811 · HPX
Maurry Biological Co.
Ophthalmic · 96d
Cleared Dec 16, 1985
MEMBRANE OXYGENATING SYS ADULT BMOS-7 & BMOS-3 PED
K854045 · DTZ
American Bentley
Cardiovascular · 75d
Cleared Dec 16, 1985
PUPILSCAN
K854169
Fairville Medical Optics, Inc.
Ophthalmic · 62d
Cleared Dec 16, 1985
ROOT CANAL FILLING RESIN
K854253 · KIF
Dentsply Intl.
Dental · 55d
Cleared Dec 16, 1985
FANA 60
K854314 · DHN
American Bio-Reagents, Inc.
Immunology · 49d
Cleared Dec 16, 1985
HD-SECURA HEMADIALYSIS MACHINE
K854367 · FKP
Organon Teknika Corp.
Gastroenterology & Urology · 48d
Cleared Dec 16, 1985
MODIFIED CLINICAL WIDEFIELD SPECULAR MICROSCOPE 50
K854440 · HRM
Keeler Instruments, Inc.
General & Plastic Surgery · 41d