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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
154009–154032 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 04, 1984
IRRI-CATH
K833908 · BSY
Portex, Inc.
Anesthesiology · 82d
Cleared Feb 04, 1984
TWO CHANNEL GASTROFIBERSCOPE FG-36T
K833924 · FDS
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 82d
Cleared Feb 04, 1984
SUPERIOR ENTERNAL FEEDING SYSTEM
K833947 · KNT
Superior Plastic Products Corp.
Gastroenterology & Urology · 81d
Cleared Feb 04, 1984
VANISH
K833976 · KGO
Parke-Davis Co.
General Hospital · 79d
Cleared Feb 04, 1984
PROTOPATH FACTOR IX ASSAY
K834050 · GGP
American Dade
Hematology · 73d
Cleared Feb 04, 1984
PROTOPATH FACTOR VIII ASSAY
K834051 · GGP
American Dade
Hematology · 73d
Cleared Feb 04, 1984
DART ALPHA-AMYLASE REAGENT SYSTEM
K834053 · CIJ
Coulter Electronics, Inc.
Chemistry · 73d
Cleared Feb 04, 1984
DART GAMMA-GT REAGENT SYSTEM
K834054 · JQB
Coulter Electronics, Inc.
Chemistry · 73d
Cleared Feb 04, 1984
IL 301 PORTABLE TRANSCUT. OXYGEN MONI
K834057 · KLK
Instrumentation Laboratory CO
Anesthesiology · 73d
Cleared Feb 04, 1984
RELIANCE OPHTHALMIC SLIT LAMP R-083
K834060 · HQF
F. & F. Koenigkramer
Ophthalmic · 71d
Cleared Feb 04, 1984
STERILE LABELS
K834062 · LDQ
Devon Industries, Inc.
General & Plastic Surgery · 71d
Cleared Feb 04, 1984
MATCHED COMPONENT SET FOR DIGITOXIN
K834080 · LCW
Cambridge Medical Technology
Toxicology · 68d
Cleared Feb 04, 1984
HYDROXYBUTYRATE DEHYDROGENASE REAGENT
K834084 · JKF
Sterling Biochemical, Inc.
Chemistry · 68d
Cleared Feb 04, 1984
MAHURKAR DUAL LIMEN FEMORAL CATHETER
K834109 · DQY
Quinton, Inc.
Cardiovascular · 67d
Cleared Feb 04, 1984
ANTENSE ANTI-TENSION DEVICE
K834110 · HCC
Bio Sig Instruments, Inc.
Neurology · 67d
Cleared Feb 04, 1984
PHASE II CORTISOL KIT
K834219 · CGR
Medical & Scientific Designs, Inc.
Chemistry · 61d
Cleared Feb 04, 1984
GRADUATED GUIDE WIRE BOWL 8
K834237 · DQX
Sterile Design, Inc.
Cardiovascular · 60d
Cleared Feb 04, 1984
PROGESTERONE TEST SET 125I 17-OH
K834246 · JLX
Wien Laboratories, Inc.
Chemistry · 59d
Cleared Feb 04, 1984
HODGE DECOMPRESSION TUBE
K834258 · KNT
Inmed Corp.
Gastroenterology & Urology · 59d
Cleared Feb 04, 1984
TRANS-PACE
K834262 · DRO
Micromedical Devices, Inc.
Cardiovascular · 58d
Cleared Feb 04, 1984
ISLAMI GASTROINTESTINAL TUBE
K834268 · KNT
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 58d
Cleared Feb 04, 1984
SOFTIP CATHETER
K834275 · DQO
Angiomedics, Inc.
Cardiovascular · 58d
Cleared Feb 04, 1984
INSPIRON LIQUID OXYGEN SYSTEM
K834290 · BYJ
Inspiron Corp.
Anesthesiology · 58d
Cleared Feb 04, 1984
ADULT INCONTINENCE PAD
K834295 · EYQ
Procter & Gamble Mfg. Co.
Gastroenterology & Urology · 58d