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
75601–75624 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 03, 2002
CT-C3000 SPIRAL CT SCANNER SYSTEM
K020913 · JAK
Neusoft Digital Medical Systems Co.,...
Radiology · 13d
Cleared Apr 03, 2002
SMARTSCORE 3.5
K020929 · JAK
GE Medical Systems
Radiology · 12d
Cleared Apr 03, 2002
HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706
K020935 · CGA
Hemocue, Inc.
Chemistry · 12d
Cleared Apr 02, 2002
MULTI HI-FLO PNEU, WISAP #7080
K011510 · HIF
Wisap Gesellschaft Fur Wissenschaftl....
Obstetrics & Gynecology · 321d
Cleared Apr 02, 2002
OXOID PBP2 1 LATEX AGGLUTINATION TEST
K011710 · MYI
Oxoid , Ltd.
Microbiology · 302d
Cleared Apr 02, 2002
IMMUNE CELL FUNCTION ASSAY
K013169 · NID
Cylex, Inc.
Hematology · 193d
Cleared Apr 02, 2002
CROSSPOINT TRANSACCESS CATHETER
K013363 · ITX
Trans Vascular Incorporated
Radiology · 174d
Cleared Apr 02, 2002
4.0 MM ARTHREX BIO-TENDOESIS SCREW, MODEL AR-1540B
K020043 · HWC
Arthrex, Inc.
Orthopedic · 85d
Cleared Apr 02, 2002
IQL BASIC FRAGMENT PLATE SET, IQL BASIC FRAGMENT SCREW SET, IQL SMALL...
K020221 · HRS
Biomet Orthopedics, Inc.
Orthopedic · 70d
Cleared Apr 02, 2002
BARD LUMINEXX 6 FR BILIARY STENT AND DELIVERY SYSTEM
K020682 · FGE
C.R. Bard, Inc.
Gastroenterology & Urology · 29d
Cleared Apr 01, 2002
RE-USABLE STERILIZATION POUCH / BAG
K013715 · FRG
Quality Products of Montana
General Hospital · 144d
Cleared Apr 01, 2002
SIMPLICITY SIMPLEX SOFT INFUSION SET
K020629 · FPA
Sterling Medivations, Inc.
General Hospital · 34d
Cleared Mar 29, 2002
THERMOMETER MODELS ST8132C, ST8132F, ST8142C, ST8142F, ST8532C, ST8532F,...
K013779 · FLL
Mesure Technology
General Hospital · 136d
Cleared Mar 29, 2002
LIFEGUARD SAFETY INFUSION SET
K013871 · FPA
Horizon Medical Products, Inc.
General Hospital · 128d
Cleared Mar 29, 2002
UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM
K014302 · MNH
Pisharodi Surgicals, Inc.
Orthopedic · 88d
Cleared Mar 29, 2002
RESORBABLE LACTOSORB-L ACL CROSSPIN
K014305 · HTY
Arthrotek, Inc.
Orthopedic · 88d
Cleared Mar 29, 2002
DYNA INTRA-LIMBAL LENS
K020006 · HQD
Lens Dynamics, Inc.
Ophthalmic · 86d
Cleared Mar 29, 2002
OPTILUX CURING LIGHTS
K020267 · EBZ
Sybron Dental Specialties, Inc.
Dental · 63d
Cleared Mar 29, 2002
SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452
K020467 · CFE
Helena Laboratories
Chemistry · 45d
Cleared Mar 29, 2002
MODIFICATION TO REFLEX ANTERIOR CERVICAL PLATE SYSTEM
K020650 · KWQ
Howmedica Osteonics Corp.
Orthopedic · 29d
Cleared Mar 29, 2002
DUREX LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT
K020659 · HIS
Ssl Americas, Inc.
Obstetrics & Gynecology · 28d
Cleared Mar 29, 2002
GAMMA 3 LAG SCREW
K020677 · HSB
Howmedica Osteonics Corp.
Orthopedic · 28d
Cleared Mar 29, 2002
O'REGAN DISPOSABLE ANOSCOPE
K020702 · FER
Canadian Theatre Products , Ltd.
Gastroenterology & Urology · 25d
Cleared Mar 29, 2002
VITEK 2 ANTIMIRCROBIAL SUSCEPTIBILITY TEST SYSTEM FOR LEVOFLOXACIN
K020871 · LON
bioMerieux, Inc.
Microbiology · 91d