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
79945–79968 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 09, 2001
ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R2000-CMS
K010390 · DXT
Acist Medical Systems, Inc.
Cardiovascular · 28d
Cleared Mar 09, 2001
CENTURA PHOTOTHERAPY SPOTLIGHT
K010495 · LBI
Medical Illumination International, Inc.
General Hospital · 17d
Cleared Mar 09, 2001
TELEMED 12 LEAD RESTING ECG ANALYSIS LIBRARY
K010505 · DPS
Brentwood Medical Technology Corp.
Cardiovascular · 16d
Cleared Mar 09, 2001
NICOLET VERSALAB
K010521 · JAF
Nicolet Biomedical
Radiology · 15d
Cleared Mar 08, 2001
PERFADEX SOLUTION FOR ORGAN PRESERVATION
K000881 · MSB
Vitrolife Sweden AB
Gastroenterology & Urology · 353d
Cleared Mar 08, 2001
PVS 1300 NEURO GUIDE WIRE
K002907 · DQX
Precision Vascular Systems, Inc.
Cardiovascular · 171d
Cleared Mar 08, 2001
LASER 3 SPSC300
K003058 · INI
Pride Mobility Products Corp.
Physical Medicine · 157d
Cleared Mar 08, 2001
LIFECARE COMPACT TENS DEVICE
K003369 · GZJ
Lifecare , Ltd.
Neurology · 129d
Cleared Mar 08, 2001
NEWTOM QR-DVT 9000
K003787 · OAS
Aperio Services, LLC
Radiology · 90d
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