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
141001–141024 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 02, 1987
LYMPHOCYTE MAINTENANCE MEDIUM
K864396 · KIT
Bioclinical Laboratory Services, Inc.
Pathology · 88d
Cleared Feb 02, 1987
EXTRA STRONG CONDOM
K864400 · HIS
Ansell, Inc.
Obstetrics & Gynecology · 88d
Cleared Feb 02, 1987
CMV MICROASSAY
K864420 · GQI
Diamedix Corp.
Microbiology · 84d
Cleared Feb 02, 1987
EGG-TOP TORP AND EGG-TOP PORP
K864443 · ETA
Richards Medical Co., Inc.
Ear, Nose, Throat · 82d
Cleared Feb 02, 1987
DIGOXIN/RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT
K864449 · DPO
Canadian Bioclinical, Ltd.
Chemistry · 82d
Cleared Feb 02, 1987
DELFIA(TM) TRIIODOTHYRONINE (T3) KIT
K864452 · CDP
Lkb Instruments, Inc.
Chemistry · 82d
Cleared Feb 02, 1987
REVISED RESISTANT 5 MIC PANEL
K864493 · JWY
Pasco Laboratories, Inc.
Microbiology · 80d
Cleared Feb 02, 1987
SPERM SELECT(TM)
K864524 · MQL
Pharmacia, Inc.
Pathology · 77d
Cleared Feb 02, 1987
ALFERR TIBC TUBE
K864548 · JQE
Benchmark Reagents
Chemistry · 75d
Cleared Feb 02, 1987
EBV VCA IGM ANTIBODY ASSAY KIT
K864604 · LJN
Granbio, Inc.
Microbiology · 70d
Cleared Feb 02, 1987
ATL'S ULTRAMARK 6 ULTRASOUND SYSTEM
K864657 · DXK
Advanced Technology Laboratories, Inc.
Cardiovascular · 66d
Cleared Feb 02, 1987
PATHFINDER CHLAMYDIA CULTURE CONFIRMATION SYSTEM
K864663 · LJP
Kallestad Diag, A Div. of Erbamont, Inc.
Microbiology · 66d
Cleared Feb 02, 1987
SERA-TEK THYROGLOBULIN ANTIBODY TEST
K865020 · DDC
Miles Laboratories, Inc.
Immunology · 41d
Cleared Feb 02, 1987
REVISED T-SCAN SYSTEM
K870032 · EFH
Sentek, Inc.
Dental · 28d
Cleared Jan 30, 1987
HPD HUMIDIFYING CHAMBER
K864173 · BTT
Hpd Medical, Inc.
Anesthesiology · 98d
Cleared Jan 30, 1987
ANGIOMED URETERAL D&M SETS/URETEROSCOPY GUID STENT
K864225 · FAD
Angiomed U.S., Inc.
Gastroenterology & Urology · 94d
Cleared Jan 30, 1987
EMG-1, MOTOR NERVE MONITOR
K864408 · IKN
Algotek, Inc.
Neurology · 81d
Cleared Jan 30, 1987
MODIFIED MAINFRAME OF MODEL 902 MOBILE C-ARM
K864837 · JAA
Oec-Diasonics, Inc.
Radiology · 52d
Cleared Jan 30, 1987
MOD. 4006 ADU., OXY. DELIVE.-ORAL CO2 SAM. CANNULA
K864903 · CCK
Salter Labs
Anesthesiology · 46d
Cleared Jan 30, 1987
ALPHA II DIAGNOSTIC X-RAY
K864958 · IZH
Ausonics Pty , Ltd.
Radiology · 43d
Cleared Jan 29, 1987
BLOOD LANCET
K850100 · FMK
Gainor Medical
General & Plastic Surgery · 748d
Cleared Jan 29, 1987
EVOPORT 100
K863985 · GWJ
Jedmed Instrument Co.
Neurology · 107d
Cleared Jan 29, 1987
NTE-2 THERMAL SENSITIVITY TESTER
K864345 · LQW
Sensortek, Inc.
Neurology · 86d
Cleared Jan 29, 1987
COLTENE RAPID
K870047 · ELW
Coltene, Inc.
Dental · 23d