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
115561–115584 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 27, 1992
REGALTECH MAXISCOPE
K921163 · HLI
Regaltech Pty. , Ltd.
Ophthalmic · 230d
Cleared Oct 27, 1992
IMPLA-MED HEX SCREW IMPLANTS, 18 AND 20 MM
K921854 · DZE
Impla-Med
Dental · 193d
Cleared Oct 27, 1992
DMG100 AND 500 ISOMETRIC STRENGTH DYNAMOMETER
K923262 · LBB
John Chatillon & Sons, Inc.
Neurology · 117d
Cleared Oct 27, 1992
TSRH L CONNECTOR -- MODIFICATION
K923339 · KWP
Sofamor Danek Mfg., Inc.
Orthopedic · 125d
Cleared Oct 27, 1992
CHALLENGE II - PASTE ADHESIVE
K923399 · DYH
Ormco Corp.
Dental · 109d
Cleared Oct 27, 1992
PURITAN-BENNETT MODEL 7200AE VENTILATOR
K923809 · CBK
Puritan Bennett Corp.
Anesthesiology · 90d
Cleared Oct 27, 1992
ACQSIM SIMULATOR/LOCALIZER
K923851 · KPQ
Philips Medical Systems (Cleveland),...
Radiology · 88d
Cleared Oct 27, 1992
IPS CERAMIC ETCHING GEL
K923926 · ELL
Ivoclar North America, Inc.
Dental · 83d
Cleared Oct 27, 1992
QUICKANCHOR
K924665 · JDR
Mitek Surgical Products, Inc.
Orthopedic · 47d
Cleared Oct 26, 1992
SENSORMEDICS 4000 SERIES SLEEP SYSTEM
K915856 · OLZ
Sensor Medics Corp.
Neurology · 304d
Cleared Oct 26, 1992
SENSORMEDICS MODEL 2130 SPIEOMETRY SYSTEM
K920111 · BZG
Sensor Medics Corp.
Anesthesiology · 290d
Cleared Oct 26, 1992
LOPEZ VALVE WITH NG SUMP TUBE
K921104 · FEG
Icu Medical, Inc.
Gastroenterology & Urology · 231d
Cleared Oct 26, 1992
VYGON POLYURETHANE VENOUS/ARTERIAL XRO UMBIL. CATH
K921352 · FOS
Vygon Corp.
General Hospital · 221d
Cleared Oct 26, 1992
VYGON XRO VENOUS/ARTERIAL UMBILICAL CATHETER
K921374 · FOS
Vygon Corp.
General Hospital · 221d
Cleared Oct 26, 1992
SYSTEM 2000, ROTATIONAL VESTIBULAR CHAIR
K922037 · LXV
Micromedical Technologies, Inc.
Ear, Nose, Throat · 178d
Cleared Oct 26, 1992
COAG-CONTROL [N] KIT
K922174 · GGN
American Bioproducts Co.
Hematology · 171d
Cleared Oct 26, 1992
VERT-X UNIVERSAL VERTICAL BUCKY STAND
K922443 · IXY
Afp Imaging Corp.
Radiology · 157d
Cleared Oct 26, 1992
KODAK AMERLITE MAB FT3 ASSAY
K922713 · CEC
Eastman Kodak Company
Chemistry · 143d
Cleared Oct 26, 1992
BECKMAN VALPROIC ACID REAGENT
K922844 · LEG
Beckman Instruments, Inc.
Toxicology · 136d
Cleared Oct 26, 1992
IL TEST APOLIPOROTEIN B (APO B)
K923080 · MSJ
Instrumentation Laboratory CO
Immunology · 123d
Cleared Oct 26, 1992
IL TEST APOLIPOPROTEIN A1
K923087 · MSJ
Instrumentation Laboratory CO
Immunology · 123d
Cleared Oct 26, 1992
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM
K923122 · LFY
Biomerieux Vitek, Inc.
Microbiology · 122d
Cleared Oct 26, 1992
CORDIS STEERABLE GUIDEWIRE
K923134 · DQX
Cordis Corp.
Cardiovascular · 119d
Cleared Oct 26, 1992
DIAMOND COATED DENTAL INSERTS
K923639 · ELC
Dentsply Intl.
Dental · 97d