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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
103105–103128 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 02, 1995
DENTAL IMPLANT SYSTEM 4.0MM AND 5.5MM LENGTH
K912521 · DZE
Bud Industries, Inc.
Dental · 1440d
Cleared May 02, 1995
NEPHRETECT
K934066 · JOJ
Alden Scientific, Inc.
General Hospital · 620d
Cleared May 02, 1995
PLASMA FIBRINOGEN CONTROL LEVEL 1/LEVEL 2
K935598 · GIL
Clinical Controls, Inc.
Hematology · 529d
Cleared May 02, 1995
2.3 MM DISPOSABLE NEUROVIEW ENDOSCOPE
K940483 · HRX
Neuro Navigational Corp.
Orthopedic · 454d
Cleared May 02, 1995
BRAINTRACE
K940811 · OLT
Brainstorms Monitoring Corp.
Neurology · 434d
Cleared May 02, 1995
NORFOLK OMEGA PORT-LP SUBCUTANEOUSLY IMPLANTED
K942784 · LJT
Norfolk Medical Products, Inc.
General Hospital · 322d
Cleared May 02, 1995
WATERS PICO TAG CHEM PACK/FREE AMINO ACID ANALYSIS
K943978 · JJF
Waters Chromatography Division
Chemistry · 259d
Cleared May 02, 1995
C-SERIES HOMEPUMP
K944692 · FPA
Block Medical, Inc.
General Hospital · 221d
Cleared May 02, 1995
MALLORY-HEAD MODULAR CALCAR REPACEMENT COMPONENTS
K945115 · JDI
Biomet, Inc.
Orthopedic · 196d
Cleared May 02, 1995
FX-2P NMS (2 CHANNEL PORTABLE)
K945508 · IPF
Fx-2
Physical Medicine · 174d
Cleared May 02, 1995
FX-2 NMS (2CHANNEL TABLE MODEL)
K945509 · IPF
Fx-2
Physical Medicine · 174d
Cleared May 02, 1995
FX-4 NMS (4CHANNEL TABLE MODEL)
K945510 · IPF
Fx-2
Physical Medicine · 174d
Cleared May 02, 1995
HICHEM Y-GT REAGENT KIT
K946192 · JQB
Hichem Diagnostics
Chemistry · 133d
Cleared May 02, 1995
STRATO MEDICAL INFUSE-A-CATH, TRIPLE LUMEN POLYURETHANE, CENTRAL VNOUS...
K946250 · LJS
Strato Medical Corp.
General Hospital · 130d
Cleared May 02, 1995
E TEST FOR OFLOXACIN
K946364 · JWY
Ab Biodisk
Microbiology · 134d
Cleared May 02, 1995
TDX(R)/TDXFLX(R) FREE PHENYTOIN II
K950280 · MOJ
Abbott Laboratories
Toxicology · 98d
Cleared May 02, 1995
FOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM, IN VITRO DIAGNOSTIC SYSTEM
K950292 · CGN
Miles, Inc.
Chemistry · 97d
Cleared May 02, 1995
POLARIS
K950388 · CCK
Spegas Industries, Ltd.
Anesthesiology · 90d
Cleared May 02, 1995
VISUALINE II CANNABINOIDS (THC)
K950445 · LDJ
Sun Biomedical Laboratories, Inc.
Toxicology · 95d
Cleared May 02, 1995
BURR, CORNEAL, BATTERY-POWERED
K950520 · HOG
Aaron Medical Industries
Ophthalmic · 85d
Cleared May 02, 1995
INDEX ACETABULAT COMPONENT
K950761 · JDI
Biomet, Inc.
Orthopedic · 74d
Cleared May 02, 1995
CHEMILUMINESCENCE TSH 3RD GENERATION IMMUNOASSAY
K950921 · JLW
Nichols Institute Diagnostics
Chemistry · 62d
Cleared May 02, 1995
POWER RANGERS SUNGLASSES
K951008 · HQY
Siegel,Mandell & Davidson,P.C.
Ophthalmic · 57d
Cleared May 02, 1995
DISPOSABLE PROPHYLAXIS ANGLE
K951016 · EHK
Preventive Technologies, Inc.
Dental · 57d