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
144937–144960 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 27, 1986
CILCO SONOMETRICS A&B DIGITAL SYSTEM (DIGISCAN)
K854969 · IYO
Cilco, Inc.
Radiology · 78d
Cleared Feb 27, 1986
CANON NON-MYDRIATIC RETINAL CAMERA CR3-45NM
K855170 · HKI
Canon USA, Inc.
Ophthalmic · 63d
Cleared Feb 27, 1986
AIR/FLUID EXCHANGE SYSTEM
K855215 · FRN
Mira, Inc.
General Hospital · 59d
Cleared Feb 27, 1986
HOWMEDICA BIPOLAR PROSTHESIS
K855231 · KWY
Howmedica Corp.
Orthopedic · 59d
Cleared Feb 27, 1986
DIGILAB CAMBRIDGE PERIMETER
K860115 · HOO
Bio-Rad
Ophthalmic · 45d
Cleared Feb 27, 1986
OPERATING ROOM TRAY
K860160 · FSM
Medical Design Concepts, Inc.
General & Plastic Surgery · 42d
Cleared Feb 27, 1986
MAZING HEAT DISPOSABLE WARM PACK
K860444 · IMD
Leebryan Intl.
Physical Medicine · 23d
Cleared Feb 27, 1986
G.A.S./GRIESHABER AIR SYSTEM
K860502 · FRN
Grieshaber & Co.
General Hospital · 16d
Cleared Feb 26, 1986
GRECO-HARVEY SURFACTANT BONDED CATHETER FOR CARDIO
K851241 · DQY
Cook, Inc.
Cardiovascular · 365d
Cleared Feb 26, 1986
SENTRY II NONINDWELLING BLOOD PRESSURE MONITOR
K852421 · DXN
Nbs Medical, Inc.
Cardiovascular · 264d
Cleared Feb 26, 1986
CARDISUNY 501 A
K852829 · DPS
Atrix
Cardiovascular · 238d
Cleared Feb 26, 1986
NEOCARE MODEL 800 INFANT RADIANT WARMER
K853926 · FMT
Draeger Medical, Inc.
General Hospital · 155d
Cleared Feb 26, 1986
OSCOR MEDICAL UNIPOLAR PERMANENT PACING LEAD-CONNE
K854128 · DTB
Oscor Medical Corp.
Cardiovascular · 140d
Cleared Feb 26, 1986
HEATER PROBE-ACCESS FOR MEDPACIFIC LD5000 LASER -
K854500 · DPW
Medpacific Corp.
Cardiovascular · 106d
Cleared Feb 26, 1986
COATEST PLASMINOGEN
K854572 · DDX
Kabivitrum, Inc.
Hematology · 104d
Cleared Feb 26, 1986
MODIFIED CORDIS PTCA GUIDING CATHETERS
K854576 · DQO
Cordis Corp.
Cardiovascular · 105d
Cleared Feb 26, 1986
TRAVELPAK MODEL DC-202
K854748 · CAW
Travomed, Inc.
Anesthesiology · 92d
Cleared Feb 26, 1986
CPR SLIDE EIKEN
K854819 · DCN
Syn-Kit, Inc.
Immunology · 85d
Cleared Feb 26, 1986
AMI E-Z-PACE ELECTODE
K854924 · DRO
A.M.I. Corp.
Cardiovascular · 78d
Cleared Feb 26, 1986
QUANTIMETRIC PLUS LAMBDA REAGENT KIT
K855007 · DEH
Kallestad Laboratories, Inc.
Immunology · 72d
Cleared Feb 26, 1986
QUANTIMETRIC PLUS KAPPA REAGENT KIT
K855008 · DFH
Kallestad Laboratories, Inc.
Immunology · 72d
Cleared Feb 26, 1986
QUANTIMETRIC PLUS IGA REAGENT KIT
K855009 · CZP
Kallestad Laboratories, Inc.
Immunology · 72d
Cleared Feb 26, 1986
QUANTIMETRIC PLUS C3 REAGENT KIT
K855011 · CZN
Kallestad Laboratories, Inc.
Immunology · 72d
Cleared Feb 26, 1986
QUANTIMETRIC PLUS C4 REAGENT KIT
K855012 · DBI
Kallestad Laboratories, Inc.
Immunology · 72d