Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
151201–151224 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 06, 1984
ARGON LASER PHOTOCOAGULATOR SYS
K843965 · HQF
American Medical Optics
Ophthalmic · 26d
Cleared Nov 05, 1984
DISPOSABLE LATEX BANDAGE
K842301 · KGX
Inmed Corp.
General & Plastic Surgery · 147d
Cleared Nov 05, 1984
AMER. EDWARDS LAB FLEXISCOPE
K842410 · HRK
American Edwards Laboratories
Ophthalmic · 139d
Cleared Nov 05, 1984
BAND-AID BRAND ADHESIVE BANDAGE-MEDICA
K842511 · KGX
Johnson & Johnson Professionals, Inc.
General & Plastic Surgery · 132d
Cleared Nov 05, 1984
HTS FILTER DIGITAL SUBTRACT. ANGIOGRAPHY
K842691
Health Technology Services
Neurology · 117d
Cleared Nov 05, 1984
ROCHE REAGENT FOR AST
K843109 · CIT
Roche Diagnostic Systems, Inc.
Chemistry · 90d
Cleared Nov 05, 1984
SURGEONS CHOICE PI VASCULAR STAPLING
K843399 · GDW
Surgeons Choice, Inc.
General & Plastic Surgery · 67d
Cleared Nov 05, 1984
SUTURE TRAY
K843525
Pro-Lab, Inc.
General & Plastic Surgery · 59d
Cleared Nov 05, 1984
TRENDS LANCET
K843882 · KMK
Orange Medical Instruments, Inc.
General Hospital · 34d
Cleared Nov 05, 1984
SNYDER HEMOVAC WOUND DRAINAGE DEVICES
K843906 · GBS
Snyder Laboratories, Inc.
General & Plastic Surgery · 33d
Cleared Nov 05, 1984
GILL'S IRRIGATOR/ASPIRATOR NEEDLE
K843925 · GAA
Concept, Inc.
General & Plastic Surgery · 31d
Cleared Nov 05, 1984
SUSPENSION 7
K843985
Cgr Medical Corp.
Radiology · 25d
Cleared Nov 05, 1984
AZTECH INDUSTRIES SUNTANNING BED AZ100
K844039 · FTC
Aztech Industries, Inc.
General & Plastic Surgery · 20d
Cleared Nov 05, 1984
DERMIZIP SKIN CLOSURE DEVICE
K844072
Kells Medical, Inc.
General & Plastic Surgery · 18d
Cleared Nov 02, 1984
TEMPTREND PEDS AXILLARY TEMP. INDICATOR
K841913 · KPD
Biosynergy, Inc.
General Hospital · 177d
Cleared Nov 02, 1984
I.V. TEAMATE
K842479 · FRN
Medical Delivery Systems
General Hospital · 130d
Cleared Nov 02, 1984
ABBOTT HTSH EIA DIAGNOSTIC KIT
K843540 · JLW
Abbott Laboratories
Chemistry · 56d
Cleared Nov 02, 1984
VITAJET JET INSULIN INJECTION DEVICE
K843784 · KZE
Vitajet Industriae Comercioltda.
General Hospital · 37d
Cleared Nov 02, 1984
HDL PRECIPATATING REAGENT SET
K843894 · LBR
Livonia Diagnostics, Inc.
Chemistry · 30d
Cleared Nov 01, 1984
PERICARDIAL PATCH
K833763 · DXZ
American Edwards Laboratories
Cardiovascular · 372d
Cleared Nov 01, 1984
AUTOFLOUR III SYSTEM
K841984 · DHN
Tech America Diagnostics
Immunology · 170d
Cleared Nov 01, 1984
SUN-ONE
K842048 · BZQ
Ensun Medical Products, Inc.
Anesthesiology · 163d
Cleared Nov 01, 1984
PHARMACIA B2-MICRO RIA
K842772 · JGZ
Pharmacia, Inc.
Immunology · 108d
Cleared Nov 01, 1984
TERM GUARD 5000 UTERINE ACTIVITY
K843011 · HFM
Tokos Medical Corp.
Obstetrics & Gynecology · 93d