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
107113–107136 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 02, 1994
ORVIS POLARIZED BI-FOCALS
K943131 · HQY
The Orvis Co., Inc.
Ophthalmic · 34d
Cleared Aug 02, 1994
OPTILINE, CARLO BELLINI, EXPLOREFLEX, STRATFORD & TITINIFLEX
K943236 · HQZ
Optiline Imports and Trade, Inc.
Ophthalmic · 27d
Cleared Aug 02, 1994
SPECTACLE FRAMES
K943442 · HQZ
Sunny Union Industrial Co., Ltd.
Ophthalmic · 15d
Cleared Aug 02, 1994
SUNGLASSES
K943443 · HQY
Sunny Union Industrial Co., Ltd.
Ophthalmic · 15d
Cleared Aug 01, 1994
INTEGRAL III BIOINTEGRATED DENTAL IMPLANT SYSTEM
K925490 · DZE
Calcitek, Inc.
Dental · 637d
Cleared Aug 01, 1994
ARTHROTEK SET SCREW
K932721 · HWC
Biomet, Inc.
Orthopedic · 423d
Cleared Aug 01, 1994
DALL MILES SYSTEM GROOVED BUTTON
K934059 · JDQ
Howmedica Corp.
Orthopedic · 347d
Cleared Aug 01, 1994
BVR CONTRA-ANGLE HANDPIECE
K934571 · EGS
Bvr Aero Precision Corp.
Dental · 319d
Cleared Aug 01, 1994
MODEL 644 SWEAT DILUENT
K935228 · CGZ
Ciba Corning Diagnostics Corp.
Chemistry · 273d
Cleared Aug 01, 1994
MAYTEX LATEX EXAMINATION GLOVES, POWDERED
K935314 · LYY
Maytex Corp.
General Hospital · 272d
Cleared Aug 01, 1994
MAYTEX POWDER-FREE LATEX EXAMINATION GLOVES
K935315 · LYY
Maytex Corp.
General Hospital · 272d
Cleared Aug 01, 1994
AS/3(TM) ANESTHESIA MONITOR SYST INTERFACE BOARD
K935477 · CCK
Datex Division Instrumentarium Corp.
Anesthesiology · 259d
Cleared Aug 01, 1994
MODEL GP-252 GENERAL PURPOSE COIL
K935691 · LNH
Diagnostic Instrument Corp.
Radiology · 245d
Cleared Aug 01, 1994
DTX AND DTX PLUS DISPOSABLE PRESSURE TRANSDUCERS AND ACCESSORIES
K935782 · DXN
Ohmeda Medical
Cardiovascular · 238d
Cleared Aug 01, 1994
EXTRAORAL HEADGEAR
K936151 · DZB
Dentauraum, Inc.
Dental · 217d
Cleared Aug 01, 1994
PROBE TIP/PERI PROBE/PERI PROBE COMP.
K936221 · EIX
Pd International AB
Dental · 217d
Cleared Aug 01, 1994
PELVIC RADIUS PLATE
K936233 · HRS
Smith & Nephew Richards, Inc.
Orthopedic · 215d
Cleared Aug 01, 1994
IMAGYN MEDICAL INFLATION DEVICE WITH NON-INVASIVE PRESSURE TUBING
K940425 · MAV
Imagyn Medical, Inc.
Cardiovascular · 182d
Cleared Aug 01, 1994
ROSSMAX INTERNATIONAL LIMITED ACCURACY BLOOD PRESSURE MONITOR
K940620 · DXN
Quality Systems Design, Inc.
Cardiovascular · 168d
Cleared Aug 01, 1994
LIQUID AMYLASE (CNPG3) REAGENT SET
K940735 · CIJ
Pointe Scientific, Inc.,
Chemistry · 165d
Cleared Aug 01, 1994
MICROVIEW II/MICRORAIL II CATHETERS
K942231 · DQO
Cardiovascular Imaging Systems, Inc.
Cardiovascular · 87d
Cleared Aug 01, 1994
CEDIA DAU MULTI-LEVEL THC ASSAY
K942337 · LDJ
Microgenics Corp.
Toxicology · 77d
Cleared Aug 01, 1994
ASHERMAN CHEST BANDAGE
K942757 · MGP
Asherman Medical Products, LLC
General & Plastic Surgery · 52d
Cleared Aug 01, 1994
CEDIA DAU BENZODIAZEPINE ASSAY
K942795 · JXM
Microgenics Corp.
Toxicology · 54d