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
118897–118920 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 02, 1991
OPTIFIBER
K914423 · GEX
Minimal Invasive Therapy and...
General & Plastic Surgery · 60d
Cleared Dec 02, 1991
BENNETT OVERHEAD TUBE CRANE MODEL NO. B-OTC
K914944 · IYB
Bennett X-Ray Corp.
Radiology · 28d
Cleared Dec 02, 1991
KODAK MIN-R IDENTIFICATION CAMERA
K915088 · JAC
Eastman Kodak Company
Radiology · 20d
Cleared Nov 29, 1991
EPO-RIA
K910481 · GGT
Ramco Laboratories, Inc.
Hematology · 296d
Cleared Nov 29, 1991
PB100 DIAGNOSTIC SPIROMETER
K911143 · BZM
Puritan Bennett Corp.
Anesthesiology · 260d
Cleared Nov 29, 1991
MAXIMA-10
K911206 · FLE
Stirn Industries
General Hospital · 255d
Cleared Nov 29, 1991
BIRD NEBULIZATION SYNCHRONIZER
K911336 · CBK
Bird Products Corp.
Anesthesiology · 248d
Cleared Nov 29, 1991
DAIG FAST CATH(TM) TRANSSEPTAL SHEATH INTRODUCER
K911883 · DYB
Diag Corp.
Cardiovascular · 214d
Cleared Nov 29, 1991
MINI-OP ATS BLOOD RECOVERY BAG, MOEL 2950
K912609 · CAC
Atrium Medical Corp.
Anesthesiology · 170d
Cleared Nov 29, 1991
MINI-OP ATS BLOOD RECOVERY BAG, MODEL 2955
K912610 · CAC
Atrium Medical Corp.
Anesthesiology · 170d
Cleared Nov 29, 1991
I.V. FILTER EXTENSION SET
K912848 · FPB
Filtertek, Inc.
General Hospital · 154d
Cleared Nov 29, 1991
ATRIUM DUAL ATS WATER SEAL CHEST DRAIN UNIT
K912956 · CAC
Atrium Medical Corp.
Anesthesiology · 144d
Cleared Nov 29, 1991
ABBOTT IMX TOXO IGM POSITIVE CONTROL
K913106 · LGD
Abbott Laboratories
Microbiology · 140d
Cleared Nov 29, 1991
ABBOTT MATRIX AERO PLUS SYSTEM
K913150 · DHB
Abbott Laboratories
Immunology · 136d
Cleared Nov 29, 1991
C-150 ULTRAFAST CT SCANNER
K913352 · JAK
Imatron, Inc.
Radiology · 126d
Cleared Nov 29, 1991
KANGAROO(R) PET(TM) ENTERAL FEED PUMP/CHARGER BASE
K913413 · LZH
Sherwood Medical Co.
General Hospital · 121d
Cleared Nov 29, 1991
MAG RES IMAG SYST/BRUKER MODEL R28 WHOLE BODY SCAN
K913463 · LNH
Bruker Medical Imaging, Inc.
Radiology · 116d
Cleared Nov 29, 1991
SNAPPER
K913608 · KPE
Healthtek, Inc.
General Hospital · 107d
Cleared Nov 29, 1991
INFRARED HEAT LAMP MODEL NH-201
K913856 · ILY
National Health-Care Equipment, Inc.
Physical Medicine · 94d
Cleared Nov 29, 1991
INFRARED HEAT LAMP MODEL NH-202
K913880 · ILY
National Health-Care Equipment, Inc.
Physical Medicine · 92d
Cleared Nov 29, 1991
1.9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION
K913955 · FFK
Northgate Technologies, Inc.
Gastroenterology & Urology · 85d
Cleared Nov 29, 1991
INFRARED HEAT LAMPS & MASSAGER MODEL NH-213
K913973 · ILY
National Health-Care Equipment, Inc.
Physical Medicine · 84d
Cleared Nov 29, 1991
IL TEST(TM DIGOXIN
K914151 · KXT
Instrumentation Laboratory CO
Immunology · 74d
Cleared Nov 29, 1991
HYDRODISECTOR
K914177 · JCX
Spiess Design, Inc.
General & Plastic Surgery · 72d