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
85777–85800 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 08, 1999
C-LEG (3C100)
K991590 · ISW
Otto Bock Orthopedic Industry, Inc.
Physical Medicine · 62d
Cleared Jul 08, 1999
TITANIUM LOW PROFILE SCREWS
K991807 · LPH
Biomet, Inc.
Orthopedic · 43d
Cleared Jul 08, 1999
VOLUSION SMALL PARTS TRANSDUCER, MODEL S-VNW 5-10, VOLUSION ABDOMINAL...
K992155 · ITX
Medison America, Inc.
Radiology · 13d
Cleared Jul 07, 1999
SPECIALITY 55 MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES...
K984090 · LPL
Specialty Ultravision, Inc.
Ophthalmic · 233d
Cleared Jul 07, 1999
RAPIDONE - MARIJUANA TEST
K990818 · LDJ
American Bio Medica Corp.
Toxicology · 118d
Cleared Jul 07, 1999
VISER PENILE TUMESCENCE MONITOR
K991479 · LIL
Laborie Medical Tech Corp.
Gastroenterology & Urology · 70d
Cleared Jul 07, 1999
BISTITE II SC
K991711 · EMA
Tokuyama America, Inc.
Dental · 49d
Cleared Jul 07, 1999
N LATEX IGE MONO REAGENT
K991787 · DGC
Dade Behring, Inc.
Immunology · 43d
Cleared Jul 07, 1999
NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH A PROTEIN LABELING...
K991849 · LYY
Seal Polymer Industries Bhd.
General Hospital · 36d
Cleared Jul 07, 1999
OCUSYSTEM ART ADVANTAGE, MODEL 995
K991852 · HQC
Surgical Design Corp.
Ophthalmic · 36d
Cleared Jul 07, 1999
ADVENTURE TINTS PROSTHETIC TINTED SOFT CONTACT LENS
K992054 · LPL
Adventures IN Color Technology, Ltd.
Ophthalmic · 20d
Cleared Jul 06, 1999
TAMPA HYPERBARIC MONOPLACE CHAMBER
K981938 · CBF
Tampa Hyperbaric Ent.
Anesthesiology · 399d
Cleared Jul 06, 1999
DURAGEN DURAL GRAFT MATRIX
K982180 · GXQ
Integra Lifesciences Corp.
Neurology · 379d
Cleared Jul 06, 1999
LIFESTYLES XTRA PLEASURE
K983518 · HIS
Ansell, Inc.
Obstetrics & Gynecology · 272d
Cleared Jul 06, 1999
SMITH & NEPHEW SUBCUTANEOUS ILLUMINATOR
K991323 · FFS
Smith & Nephew, Inc.
Gastroenterology & Urology · 78d
Cleared Jul 06, 1999
QUADRATURE WRIST COIL, MODEL 445PH-64
K991434 · MOS
Medical Advances, Inc.
Radiology · 71d
Cleared Jul 06, 1999
IMMERGE IMAGE CORRELATION
K991468 · LLZ
Surgical Navigation Technologies, Inc.
Radiology · 70d
Cleared Jul 06, 1999
SAMSUNG RAYPAX SYSTEM
K991537 · LMD
Samsung Sds Co., Ltd.
Radiology · 64d
Cleared Jul 06, 1999
MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR...
K991955 · BTM
Engineered Medical Systems
Anesthesiology · 35d
Cleared Jul 06, 1999
STATUS STIK, ACCUSIGN STIK
K992068 · DKE
Princeton BioMeditech Corp.
Toxicology · 18d
Cleared Jul 06, 1999
IMMULITE TURBO INTACT PTH, MODEL LSKPTZ
K992105 · CEW
Diagnostic Products Corp.
Chemistry · 14d
Cleared Jul 02, 1999
DD URETERAL STENT, INTEGRAL STENT
K982974 · FAD
Rusch Intl.
Gastroenterology & Urology · 311d
Cleared Jul 02, 1999
MODIFICATION TO GAMMA GUIDANCE SYSTEM
K983768 · IZD
Radiation Monitoring Devices, Inc.
Radiology · 249d
Cleared Jul 02, 1999
RETROGRADE CARDIOPLEGIA CANNULA WITH DURAFLO TREATMENT, MODEL DII-RC-014
K991170 · DWF
Edwards Lifesciences Research Medical
Cardiovascular · 86d