FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
77425–77448 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 16, 2001
RUSCH PERCUTANEOUS NEPHROSTOMY CATHETER SETS
K011121 · LJE
Rusch Intl.
Gastroenterology & Urology · 218d
Cleared Nov 16, 2001
BALLPEN SPINAL NEEDLE W/WO INTRODUCER
K011122 · BSP
Rusch Intl.
Anesthesiology · 218d
Cleared Nov 16, 2001
SNAZZY2
K011473 · INI
Shoprider Intl., Inc.
Physical Medicine · 186d
Cleared Nov 16, 2001
MACS HMA ANTERIOR SPINAL STABILIZATION SYSTEM
K011556 · KWQ
Aesculap, Inc.
Orthopedic · 179d
Cleared Nov 16, 2001
IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE
K011586 · GAA
Diametrics Medical, Inc.
Chemistry · 177d
Cleared Nov 16, 2001
POWERHEART CARDIAC RHYTHM MODULE
K012197 · MKJ
Cardiac Science, Inc.
Cardiovascular · 126d
Cleared Nov 16, 2001
AMEDITECH IMMUTEST DRUG SCREEN METHAMPHETAMINE
K012585 · LAF
Ameditech, Inc.
Toxicology · 98d
Cleared Nov 16, 2001
DISCOVERY FACET SCREW FIXATION SYSTEM
K012773 · MRW
Depuyacromed
Orthopedic · 88d
Cleared Nov 16, 2001
JOSTRA ARTERIAL PERFUSION CANNULAE
K012774 · DWF
Jostra AG
Cardiovascular · 88d
Cleared Nov 16, 2001
DURACON CONSTRAINED POSTERIOR STABILIZED (PS) TIBIAL INSERT
K012776 · JWH
Howmedica Osteonics Corp.
Orthopedic · 88d
Cleared Nov 16, 2001
TWINTRODE ELC 134 ELECTRODE
K012785 · LNS
Healthtronics Surgical Services, Inc.
Gastroenterology & Urology · 88d
Cleared Nov 16, 2001
CYNOSURE PHOTOGENICA ER
K012790 · GEX
Cynosure, Inc.
General & Plastic Surgery · 88d
Cleared Nov 16, 2001
INTEX SCREW
K012798 · HWC
Biomet, Inc.
Orthopedic · 87d
Cleared Nov 16, 2001
SEMPERMED DERMA PLUS, SIZES 5.5,6,6.5,7,7.5,8,8.5,9
K012819 · KGO
Semperit Technische Produkte Gesellshaft
General Hospital · 85d
Cleared Nov 16, 2001
INTUITIVE SURGICAL BIPOLAR FORCEPS
K012833 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 85d
Cleared Nov 16, 2001
SMART GLOVE STERILE NITRILE EXAM GLOVE
K012853 · LZA
Smart Glove Corp. Sdn Bhd
General Hospital · 84d
Cleared Nov 16, 2001
STERILE LATEX EXAMINATION GLOVES (POWDERED) WITH PROTEIN CLAIM LESS THAN 100UG/G
K012856 · LYY
Smart Glove Corp. Sdn Bhd
General Hospital · 84d
Cleared Nov 16, 2001
STERILE POWDER-FREE LATEX SURGICAL GLOVES (50 MICROGRAMS OR LESS)
K012880 · KGO
Ssn Gloves (M) Sdn Bhd
General Hospital · 80d
Cleared Nov 16, 2001
STERILE POWDERED LATEX SURGICAL GLOVES WITH PROTEIN LABELING CLAIM (200...
K012896 · KGO
Ssn Gloves (M) Sdn Bhd
General Hospital · 80d
Cleared Nov 16, 2001
MEDSTAR 100 INTERFERENTIAL STIMLATOR
K013082 · LIH
Mednet Services, Inc.
Neurology · 63d
Cleared Nov 16, 2001
WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311
K013095 · CEO
Wiener Laboratories Saic
Chemistry · 60d
Cleared Nov 16, 2001
WIENER LAB. AMILASA 405 CINETICA AA, WIENER LAB.AMILASA 405 CINETICA...
K013101 · JFJ
Wiener Laboratories Saic
Chemistry · 60d
Cleared Nov 16, 2001
VALIDATE CHEM 6 CALIBRATION VERIFICATION TEST SET MODEL # 10006
K013119 · JJX
Maine Standards Co.
Chemistry · 59d
Cleared Nov 16, 2001
BIOSCANNER BEYOND GLUCOSE ANALYZER AND TEST STRIPS
K013203 · NBW
Polymer Technology Systems, Inc.
Chemistry · 52d