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
78001–78024 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 21, 2001
LH 450 ENTERAL FEEDING BAG PUMP SET W/INTEGRATED Y-PORT
K011340 · KNT
Lh Medical Products, Inc.
Gastroenterology & Urology · 142d
Cleared Sep 21, 2001
LH400 YES-SET Y-PORT ENTERAL SPIKE PUMP SET
K011341 · KNT
Lh Medical Products, Inc.
Gastroenterology & Urology · 142d
Cleared Sep 21, 2001
LH 500 ENTERAL FEEDING GRAVITY BAG SET
K011343 · KNT
Lh Medical Products, Inc.
Gastroenterology & Urology · 142d
Cleared Sep 21, 2001
STS RANGE , MODELS STS20,STS30,STS40
K012008 · JOW
Huntleigh Healthcare, Inc.
Cardiovascular · 86d
Cleared Sep 21, 2001
AETMED IMAGE PROCESSING SOFTWARE
K012093 · LLZ
Aetmed, S.P.A.
Radiology · 78d
Cleared Sep 21, 2001
AUDIOSCAN VERIFIT, MODEL VF-1
K012306 · ETW
Etymonic Design, Inc.
Ear, Nose, Throat · 60d
Cleared Sep 21, 2001
WIENER LAB.ALBUMINA AA, MODELS 6X60 ML CAT N 1690008, 6X120 ML CAT 1009300
K012329 · CIX
Wiener Laboratories Saic
Chemistry · 60d
Cleared Sep 21, 2001
SQA, SPERM QUALITY ANALYZER
K012352 · POV
Medical Electronic Systems, LLC
Hematology · 58d
Cleared Sep 21, 2001
SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT)
K012456 · ERL
Sodemsystems
Ear, Nose, Throat · 51d
Cleared Sep 21, 2001
MALE LATEX CONDOM
K012653 · HIS
Qingdao Shuang Die Latex Production...
Obstetrics & Gynecology · 39d
Cleared Sep 21, 2001
COLLAGEN NERVE CUFF
K012814 · JXI
Collagen Matrix, Inc.
Neurology · 30d
Cleared Sep 21, 2001
NON-STERILE POWDER FREE PURPLE LATEX EXAMINATION GLOVE WITH BLUEBERRY SCENTED...
K012857 · LYY
Sgmp Co., Ltd.
General Hospital · 28d
Cleared Sep 21, 2001
POWDER-FREE LATEX EXAM GLOVES WITH CHOCOLATE SCENTING AND PROTEIN LABELING...
K012860 · LYY
Sgmp Co., Ltd.
General Hospital · 28d
Cleared Sep 21, 2001
NON-STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH VANILLA AND PROTEIN...
K012863 · LYY
Sgmp Co., Ltd.
General Hospital · 28d
Cleared Sep 21, 2001
ADVIA 120 HEMATOLOGY SYSTEM, CYANIDE-FREE HIGH DETERMINATION
K012904 · GKZ
Bayer Diagnostics Corp.
Hematology · 23d
Cleared Sep 20, 2001
COLLAGRAFT STRIP BONE GRAFT MATRIX (FOR USE AS A BONE FILLER), MODEL 1X,3X,6X...
K000122 · MQV
Neucoll, Inc.
Orthopedic · 611d
Cleared Sep 20, 2001
QUANTUM VERSATILITY (QVS) DENTAL IMPLANT SYSTEM
K002241 · DZE
Quantum Bioengineering, Ltd.
Dental · 423d
Cleared Sep 20, 2001
GSA GENITO SENSORY ANALYZER
K010981 · LLN
Medoc Ltd. Advanced Medical Systems
Neurology · 171d
Cleared Sep 20, 2001
QUANTUM VERSATILITY (QVS) DENTAL IMPLANT SYSTEM
K011223 · DZE
Paxmed International
Dental · 153d
Cleared Sep 20, 2001
INSIGHT MILLENNIUM PLUS
K011964 · HCC
Fasstech
Neurology · 87d
Cleared Sep 20, 2001
SURGICAL LIGHTSTIC 180, MODEL 180 L, MODEL 180 C
K011988 · OCL
Cardiofocus, Inc.
Cardiovascular · 86d
Cleared Sep 20, 2001
MODIFICATION TO LR 5200 FILM RECORDER
K012010 · LMC
Agfa Corp.
Radiology · 85d
Cleared Sep 20, 2001
MULTIFUNCTION ENDOSCOPIC INSTRUMENT
K012033 · GEI
Seedling Enterprises., LLC
General & Plastic Surgery · 83d
Cleared Sep 20, 2001
KINETIC CANNULA
K012042 · QPB
Reliance Medical Corp.
General & Plastic Surgery · 83d