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
79441–79464 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 08, 2001
DISPOSABLE CB-PE MICROKERATOME BLADES
K003820 · HNO
Oasis Medical, Inc.
Ophthalmic · 87d
Cleared Mar 08, 2001
OMNISONICS ULTRASONIC SURGERY SYSTEM, MODEL STI
K003824 · LFL
Omnisonics Medical Technologies
General & Plastic Surgery · 87d
Cleared Mar 08, 2001
FOCUS DAILIES PROGRESSIVES
K003826 · MVN
Ciba Vision Corporation
Ophthalmic · 87d
Cleared Mar 08, 2001
BENZ-MF (VISIBILITY HANGLING TINT) (METHAFILCON A) SOFT DAILY WEAR CONTACT...
K003861 · LPL
Benz Research and Development Corp.
Ophthalmic · 85d
Cleared Mar 08, 2001
SEROJET
K003908 · KZE
Bioject, Inc.
General Hospital · 79d
Cleared Mar 08, 2001
MONITECT MULTIPLE DRUG SCREEN TESTS, MODEL BC12,BC14,TC10,PC11, AND PC12
K004034 · DKZ
Branan Medical Corp.
Toxicology · 70d
Cleared Mar 08, 2001
HERACERAM 75
K010416 · EJT
Jelenko Co.
Dental · 24d
Cleared Mar 08, 2001
PROPORT PLASTIC VENOUS IMPLANTABLE ACCESS SYSTEMS PRE-ASSEMBLED WITH SILICONE...
K010426 · LJT
Sims Deltec, Inc.
General Hospital · 23d
Cleared Mar 08, 2001
KURZ ANGULAR PISTON-TITANIUM PROSTHESIS, MODELS 1006 600, 1006 601, 1006 602,...
K010442 · ETB
Heinz Kurz
Ear, Nose, Throat · 22d
Cleared Mar 07, 2001
SUPERCROSS CATHETER
K001856 · DQY
Abbott Vascular, Inc.
Cardiovascular · 261d
Cleared Mar 07, 2001
SMITH & NEPHEW SUTURE HAPLA INTERFERENCE SCREW
K002274 · HWC
Smith & Nephew, Inc.
Orthopedic · 224d
Cleared Mar 07, 2001
BREAS HA50 HUMIDIFIER, MODEL HA50
K002454 · BTT
Vital Signs, Inc.
Anesthesiology · 209d
Cleared Mar 07, 2001
CONCENTRIC GUIDE CATHETER, MODELS 90018, 90020
K003085 · DQY
Concentric Medical, Inc.
Cardiovascular · 155d
Cleared Mar 07, 2001
INFINITY ETCO2 + RESPIRATORY MECHANICS POD
K003550 · CCK
Siemens Medical Solutions USA, Inc.
Anesthesiology · 110d
Cleared Mar 07, 2001
ALLOFIT ACETABULAR SYSTEM
K003758 · KWA
Sulzer Orthopedics, Inc.
Orthopedic · 91d
Cleared Mar 07, 2001
GENERAL SURGICAL LAPAROSCOPES
K003803 · GCJ
Global Endoscopy, Inc.
General & Plastic Surgery · 89d
Cleared Mar 07, 2001
FLEXVIEW CLINICAL MONITORING SYSTEM
K003998 · MSX
Data Critical Corp.
Cardiovascular · 71d
Cleared Mar 07, 2001
SLT DIFFUSER FIBER
K010041 · GEX
Surgical Laser Technologies, Inc.
General & Plastic Surgery · 61d
Cleared Mar 07, 2001
SCIMEDX PHASE II MPO IGG ANTIBODY EIA
K010289 · MOB
Scimedx Corp.
Immunology · 35d
Cleared Mar 07, 2001
ARTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 200
K010338 · DWJ
Medivance, Inc.
Cardiovascular · 30d
Cleared Mar 07, 2001
ENDOCARE PERCUTANEOUS ACCESS SET
K010339 · KOD
Endocare, Inc.
Gastroenterology & Urology · 30d
Cleared Mar 07, 2001
ACCU-CHEK COMFORT CURVE TEST STRIP
K010362 · LFR
Roche Diagnostics Corp.
Chemistry · 29d
Cleared Mar 06, 2001
SHAVER ABLATOR
K002088 · HRX
Linvatec Corp.
Orthopedic · 238d
Cleared Mar 06, 2001
FETAL ASSIST
K002548 · HGM
Huntleigh Diagnostics , Ltd.
Obstetrics & Gynecology · 201d