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
146017–146040 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 21, 1986
NEUROPATH 4000
K854277 · HCC
Therapeutic Technologies, Inc.
Neurology · 90d
Cleared Jan 21, 1986
7200 MICROPROCESSOR VENTILATOR SYSTEM RESPIRATORY
K854300 · CBK
Puritan Bennett Corp.
Anesthesiology · 88d
Cleared Jan 21, 1986
HEARTECH MODEL IN TECH
K854315 · ESD
Hearing Tech, Inc.
Ear, Nose, Throat · 85d
Cleared Jan 21, 1986
MINIPAC (TM)
K854317 · GZJ
Medical Devices, Inc.
Neurology · 85d
Cleared Jan 21, 1986
MICRO-AIRE OTO/NEURO DRILL SYSTEM
K854331 · ERL
Micro-Aire Surgical Instruments, Inc.
Ear, Nose, Throat · 85d
Cleared Jan 21, 1986
MICRO-AIRE STAPES DRILL SYSTEM
K854332 · ERL
Micro-Aire Surgical Instruments, Inc.
Ear, Nose, Throat · 85d
Cleared Jan 21, 1986
THE MMG ENTERAL FEEDING ADMINISTRATION SET
K854660 · KNT
Medical Technologies of Georgia
Gastroenterology & Urology · 62d
Cleared Jan 21, 1986
LINK SMALL BONE PLATES
K854825 · HRS
Link America, Inc.
Orthopedic · 49d
Cleared Jan 21, 1986
WUERZBURG TITANIUM MINI BONE PLATES & BONE SCREWS
K854886 · JEY
Walter Lorenz Surgical, Inc.
Dental · 46d
Cleared Jan 21, 1986
FRESENIUS HEMODIALYSIS MACHINE A1008 BSM
K855001 · FLC
Seratronics, Inc.
Gastroenterology & Urology · 39d
Cleared Jan 21, 1986
MANUAL SURGICAL INSTRUMENTS & ACCESS.CHAMPY BONE P
K855031 · HWC
Advanced Biosearch Assn.
Orthopedic · 36d
Cleared Jan 21, 1986
ANGIOMED HARZMANN DISCS
K855077 · KOD
Angiomed U.S., Inc.
Gastroenterology & Urology · 33d
Cleared Jan 21, 1986
LIFE CORP. OXYGEN PAC
K855092 · BTL
Life Corp.
Anesthesiology · 32d
Cleared Jan 21, 1986
LACTIC DEHYDROGENASE (VV) REAGENT SET
K855157 · CFJ
Technostics Intl.
Chemistry · 26d
Cleared Jan 21, 1986
TRANSFER-TRAX (TM) SPLINT TRACTION
K855179 · HST
Comfortex, Inc.
Neurology · 26d
Cleared Jan 21, 1986
FIBERLASE 100 ND: YAG MEDICAL LASER SYSTEM
K855197 · LNK
Laser Media
Gastroenterology & Urology · 26d
Cleared Jan 21, 1986
ASAHI AM SERIES DIALYZERS
K855212 · FJI
Advocacy International, Ltd.
Gastroenterology & Urology · 22d
Cleared Jan 21, 1986
SUSPENDER ORTHOPEDIC SUSPENSION DEVICE
K860037 · HST
Comfortex, Inc.
Neurology · 15d
Cleared Jan 21, 1986
BIO SPEC GRAMAFLUOR TEST KIT
K860091 · JTO
Bio Spec, Inc.
Microbiology · 11d
Cleared Jan 17, 1986
PLT-4 PLATELET ANALYZER
K853722 · GKL
Texas Intl. Laboratories, Inc.
Hematology · 134d
Cleared Jan 17, 1986
KODAK EKTACHEM HDL CHOLESTEROL KIT
K854426 · CHH
Eastman Kodak Company
Chemistry · 73d
Cleared Jan 17, 1986
CREATININE PAP
K854766 · JFY
Boehringer Mannheim Corp.
Chemistry · 51d
Cleared Jan 17, 1986
RA 80 EIKEN
K854820 · DHR
Syn-Kit, Inc.
Immunology · 45d
Cleared Jan 17, 1986
CANTROL ELECTROPHORESIS CONTROL
K854931 · JJY
Canyon Diagnostics, Inc.
Chemistry · 38d