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

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175,820 results
144937–144960 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 09, 1986
DISPOSABLE RESCUE BREATHING DEVICE
K861054 · CAE
B & F Medical Products, Inc.
Anesthesiology · 21d
Cleared Apr 09, 1986
AR-1100 AUTOMATIC REFRACTOR
K861065 · HKO
Nidek, Inc.
Ophthalmic · 20d
Cleared Apr 09, 1986
DISPOSABLE HYPODERMIC NEEDLE SAFETY SHEATH
K861081 · FMI
Perkins & Perkins, Inc.
General Hospital · 19d
Cleared Apr 08, 1986
NIDEK US-1600 A-SCAN
K854389 · IYO
Nidek, Inc.
Radiology · 159d
Cleared Apr 08, 1986
SUPERCATH A.V. FISTULA
K854773 · FIE
Togo Medikit Co., Ltd.
Gastroenterology & Urology · 130d
Cleared Apr 08, 1986
COMPAT ENTERAL DELIVERY SYSTEMS
K855097 · KNT
Sandoz Nutrition
Gastroenterology & Urology · 106d
Cleared Apr 08, 1986
COMPAT ENTERAL DELIVERY SYSTEMS
K855098 · KNT
Sandoz Nutrition
Gastroenterology & Urology · 106d
Cleared Apr 08, 1986
SHAMPAINE RADI-OP MODEL 1700RC
K860620 · KXJ
Smith & Nephew, Inc.
Radiology · 48d
Cleared Apr 08, 1986
NUCOR COMPOSITE RESTORATIVE MATERIAL PASTE/LIQUID
K860626 · EBF
Scientific Pharmaceuticals, Inc.
Dental · 48d
Cleared Apr 08, 1986
DISPO-URETTE
K860796 · PCF
Roland J. Zwick, Inc.
Obstetrics & Gynecology · 35d
Cleared Apr 08, 1986
MEDCOMP'S FEMORAL VEIN CATHETERS
K860810 · LFK
Medical Components, Inc.
Gastroenterology & Urology · 35d
Cleared Apr 08, 1986
MARX PLAN, RADIATION THERAPY TREATMENT PLAN SYSTEM
K860849 · IWB
Marx Pland
Radiology · 33d
Cleared Apr 08, 1986
NORTA TEFLON COATED LATEX BALLOON CATHETERS
K861181 · KOD
Beiersdorf, Inc.
Gastroenterology & Urology · 8d
Cleared Apr 08, 1986
TECNOL SECURE-ALL FETAL MONITOR STRAP
K861189 · HGM
Tecnol New Jersey Wound Care, Inc.
Obstetrics & Gynecology · 8d
Cleared Apr 07, 1986
DOUBLE ANTIBODY ALBUMIN FOR DETECT MICROALBUMINURI
K851338 · JIR
Diagnostic Products Corp.
Chemistry · 369d
Cleared Apr 07, 1986
MIRAGE INTRAVENOUS INFUSION SET OLOVSON-STERILE
K852616 · FPA
Medical Hospital Equipment
General Hospital · 299d
Cleared Apr 07, 1986
POLYCATH-H CATHETER
K854308 · FOZ
Abbott Laboratories
General Hospital · 164d
Cleared Apr 07, 1986
VICKERS MEDICAL MODEL 272 TEMPERATURE MONITOR
K854598 · FLL
Vickers , Ltd.
General Hospital · 140d
Cleared Apr 07, 1986
KODAK EKTASCAN IMAGE TRANSMISSION SYSTEM
K855002 · LLZ
Eastman Kodak Company
Radiology · 115d
Cleared Apr 07, 1986
MARQUEST QC-IV TONOMETER
K855024 · JJS
Marquest Medical Products, Inc.
Chemistry · 111d
Cleared Apr 07, 1986
MODIFIED EZ DETECT OCCULT BLOOD TEST IN STOOL
K860028 · KHE
Self Care Systems, Inc.
Hematology · 94d
Cleared Apr 07, 1986
EIA MONOCLONAL TOTAL IGE KIT
K860033 · DGC
Diagnostic Products Corp.
Immunology · 91d
Cleared Apr 07, 1986
HURWITZ DIALYSIS CATHETER
K860094 · LFJ
Gish Biomedical, Inc.
Gastroenterology & Urology · 87d
Cleared Apr 07, 1986
SYRINGE PUMP: VM 07
K860218 · FRN
Vial Medical , Ltd.
General Hospital · 75d