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
131401–131424 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 19, 1989
LIPID STOPCOCK
K890580 · DTL
North American Instrument Corp.
Cardiovascular · 72d
Cleared Apr 19, 1989
PHOTOCHROMIC LENS
K890725 · HQY
Ppg Industries, Inc.
Ophthalmic · 65d
Cleared Apr 19, 1989
COATED APEX PROBE
K890735 · LQY
Analytic Technology
Dental · 65d
Cleared Apr 19, 1989
TITANIUM STAPLES
K890841 · GDW
Ethicon, Inc.
General & Plastic Surgery · 57d
Cleared Apr 19, 1989
CD TELEMETRY SYSTEMS
K891104 · DRG
Marquette Electronics, Inc.
Cardiovascular · 48d
Cleared Apr 19, 1989
NOSEY SHADES (SUNGLASSES) NONPRESCRIPTION
K891597 · HQY
Creative Images, Inc.
Ophthalmic · 30d
Cleared Apr 19, 1989
KINETIC MODEL 500
K891756 · FSY
Kinetic Biomedical Services, Inc.
General & Plastic Surgery · 27d
Cleared Apr 19, 1989
KINETIC MODEL 1000
K891757 · FSY
Kinetic Biomedical Services, Inc.
General & Plastic Surgery · 27d
Cleared Apr 19, 1989
KINETIC MODEL 132
K891758 · FSS
Kinetic Biomedical Services, Inc.
General & Plastic Surgery · 27d
Cleared Apr 19, 1989
KINETIC MODEL 330
K891759 · FSS
Kinetic Biomedical Services, Inc.
General & Plastic Surgery · 27d
Cleared Apr 19, 1989
CAM-WRAP(TM) NEW STERILIZATION PROCEDURE
K891983 · KCT
Medical Dynamics, Inc.
General Hospital · 22d
Cleared Apr 18, 1989
HEMAWIPE SYSTEM, THE CIVILIZED TEST
K884206 · KHE
Labeltape Meditect, Inc.
Hematology · 194d
Cleared Apr 18, 1989
MERIT INTELLIFLATOR(TM) & MERIT MONITOR(TM)
K884913 · DXT
Merit Medical Systems, Inc.
Cardiovascular · 141d
Cleared Apr 18, 1989
MARDX LYME DISEASE IGG IFA TEST SYSTEM
K890053 · LSR
Mardx Diagnostics, Inc.
Microbiology · 102d
Cleared Apr 18, 1989
CELL-DYN 3000 MULTI-PARAMETER HEMATOLOGY ANALYER
K890491 · GKZ
Abbott Diagnostics
Hematology · 77d
Cleared Apr 18, 1989
DIRECTIGEN1-2-3 BHCG PREGNANCY TEST
K890615 · JHI
Quidel Corp.
Chemistry · 70d
Cleared Apr 18, 1989
HI CHEM INORGANIC PHOSPHORUS REAGENT KIT #88196
K890773 · CEO
Hichem Diagnostics
Chemistry · 62d
Cleared Apr 18, 1989
PATIENT EXAMINATION GLOVE
K890976 · LYY
Cranberry (M) Sdn. Bhd.
General Hospital · 50d
Cleared Apr 18, 1989
CARERITE FACE MASK
K891141 · FXX
Cost Rite Health Products, Inc.
General Hospital · 46d
Cleared Apr 18, 1989
IRON REAGENT
K891155 · CFM
Medical Analysis Systems, Inc.
Chemistry · 43d
Cleared Apr 18, 1989
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS)
K891385 · DEW
Vitek Systems, Inc.
Chemistry · 40d
Cleared Apr 18, 1989
CORE BIOPSY NEEDLE, CATALOG CODE #54006
K891537 · GDM
Dlp, Inc.
General & Plastic Surgery · 32d
Cleared Apr 18, 1989
3MM DISPOSABLE SPECULA
K891589 · FXG
Semantodontics, Inc.
General & Plastic Surgery · 29d
Cleared Apr 17, 1989
DOCTOR KOLYNOS TOOTHBRUSH
K882572 · EFW
Whitehall Laboratories, Inc.
Dental · 299d