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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
156481–156504 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 12, 1983
EVOKED POTENTIAL SYSTEM 2000
K831651 · GWE
Ophthalmetric Corp.
Neurology · 112d
Cleared Sep 12, 1983
PLASTIC THUMB FORCEPS
K831664 · KDC
Medcare Products
General & Plastic Surgery · 112d
Cleared Sep 12, 1983
DISPOSABLE NEEDLE HOLDER
K831665 · KDC
Medcare Products
General & Plastic Surgery · 112d
Cleared Sep 12, 1983
FEMININE HYGIENE DEVICE
K831667 · HED
Snow Willow Co.
Obstetrics & Gynecology · 112d
Cleared Sep 12, 1983
STERILE FOLEY CATHETERS & UROLOGICAL
K831743 · KOD
Electromedics, Inc.
Gastroenterology & Urology · 104d
Cleared Sep 12, 1983
URIAS PRESSURE SPLINTS, & FIRST AID
K831764 · FZF
Svenol Andersen
General & Plastic Surgery · 103d
Cleared Sep 12, 1983
METABOLIC EXERCISE TESTING SYSTEM
K831780 · BZL
Warren E. Collins, Inc.
Anesthesiology · 102d
Cleared Sep 12, 1983
URODYNAMIC ANALYZER
K831788 · FAN
C.R. Bard, Inc.
Gastroenterology & Urology · 101d
Cleared Sep 12, 1983
PROTEX CONTRACEPT PLUS W/SPERM-LUB
K831816 · HIS
National Sanitary Laboratories, Inc.
Obstetrics & Gynecology · 98d
Cleared Sep 12, 1983
BALLOON DILATION HELICAL STONE EXTRACT
K831875 · FFL
Vpi
Gastroenterology & Urology · 91d
Cleared Sep 12, 1983
FEMORAL CANAL SPONGE
K831886 · NAB
Zimmer, Inc.
General & Plastic Surgery · 91d
Cleared Sep 12, 1983
DISPOSABLE FLOOR INSTRUMENTS
K831911 · KDC
Ormed Mfg., Inc.
General & Plastic Surgery · 90d
Cleared Sep 12, 1983
SAFETY PINS & RUBBER BANDS
K831915 · KDC
Ormed Mfg., Inc.
General & Plastic Surgery · 90d
Cleared Sep 12, 1983
THEOPHYLLINE TEST PACK ACA
K831934 · KLS
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 89d
Cleared Sep 12, 1983
CREATINE KINASE REAGENT CK LTS
K831965 · CGS
Electro-Nucleonics Laboratories, Inc.
Chemistry · 84d
Cleared Sep 12, 1983
BIRTHWELL BIRTHING SYSTEM
K831998 · KNC
Qulab Co.
Obstetrics & Gynecology · 83d
Cleared Sep 12, 1983
STERILE SUTURE REMOVAL SET
K832047 · KDD
Ormed Mfg., Inc.
General & Plastic Surgery · 80d
Cleared Sep 12, 1983
ANGIO-FLO CONTIN-ARTERIAL FLUSH DEV.
K832058 · KRA
Parke-Davis Co.
Cardiovascular · 77d
Cleared Sep 12, 1983
ACURACY 071, DENTAL, INTRAORAL-X-RAY
K832065 · EAP
Belmont Equipment Corp.
Radiology · 77d
Cleared Sep 12, 1983
VITA-MIST AIR COMPRESSOR & NEBULIZER
K832072 · BTI
Vita Medics
Anesthesiology · 76d
Cleared Sep 12, 1983
STERILE DISPOSABLE SYRINGE
K832101 · FMF
Lee Medical Intl., Inc.
General Hospital · 81d
Cleared Sep 12, 1983
STERILE DISP. BUTTERFLY INFUSION SET
K832104 · FPA
Lee Medical Intl., Inc.
General Hospital · 81d
Cleared Sep 12, 1983
ADMINISTRATIVE IV SET
K832105 · FPA
Lee Medical Intl., Inc.
General Hospital · 81d
Cleared Sep 12, 1983
NORMAC ANESTHETIC AGENT MONITOR
K832113 · CBS
Datex Division Instrumentarium Corp.
Anesthesiology · 74d