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
138001–138024 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 02, 1987
COMPANION MINI OXYGEN SAVER
K873901 · NFB
Puritan Bennett Corp.
Anesthesiology · 69d
Cleared Dec 02, 1987
PSEUDO ISOCHROMATIC COLOR BLINDNESS TEST BOOK - 15
K873911 · HIT
Richmond Products, Inc.
Ophthalmic · 68d
Cleared Dec 02, 1987
COLOR BOOK ILLUMINATOR STAND
K873913 · HJD
Richmond Products, Inc.
Ophthalmic · 68d
Cleared Dec 02, 1987
CAPTAIN POWER SUNGLASSES STYLES: #1020 #1021
K873983 · HQY
Arcotoys, Inc.
Ophthalmic · 63d
Cleared Dec 02, 1987
CUI, VERSAFIL(TM), STE(TM) TISSUE EXPANDER
K874276 · FZW
Cox-Uphuff Intl.
General & Plastic Surgery · 43d
Cleared Dec 02, 1987
MAXIMUM CONTROL GOWN
K874318 · FYC
Ulti-Med Intl., Inc.
General Hospital · 43d
Cleared Dec 02, 1987
NEW ANTIMICRO. AGENTS:AUGMENTIN,AZTREONAM,CIPROFLO
K874426 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 35d
Cleared Dec 02, 1987
AUTO SUTURE PURSE STRING APPLIER*
K874428 · GDJ
United States Surgical, A Division of...
General & Plastic Surgery · 35d
Cleared Dec 02, 1987
MICRO-AIRE OSTEOTOME SYSTEM OR BONE HARVESTER
K874503 · HWM
Micro-Aire Surgical Instruments, Inc.
General & Plastic Surgery · 30d
Cleared Dec 02, 1987
ALLEGRO (TM) FERRITIN IMMUNOASSAY SYSTEM
K874572 · DBF
Nichols Institute Diagnostics
Immunology · 27d
Cleared Dec 02, 1987
ANGIOMED OSTY-CUT BONE BIOPSY NEEDLE
K874585 · DWO
Angiomed U.S., Inc.
General & Plastic Surgery · 23d
Cleared Dec 02, 1987
PERFORATED SOAKING TUBE
K874596 · GBQ
Specialty Medical Products Co.
General & Plastic Surgery · 23d
Cleared Dec 02, 1987
TECNOL FLUID SHIELD SURGICAL MASK
K874608 · FXX
Tecnol New Jersey Wound Care, Inc.
General Hospital · 23d
Cleared Dec 02, 1987
NSN #6515-00-333-2400 ADSON DRESSING FORCEPS
K874634 · GEN
I-Tech Industries, Inc.
General & Plastic Surgery · 22d
Cleared Dec 02, 1987
CLOSED WOUND DRAINAGE SYSTEMS
K874645 · GCY
Hall Laboratories, Inc.
General & Plastic Surgery · 19d
Cleared Dec 01, 1987
WHITESIDE ORTHOLOC REVISION HIP STEM PROSTHESIS
K873857 · JDI
Dow Corning Wright
Orthopedic · 70d
Cleared Dec 01, 1987
ABBOTT PAP-EIA
K873903 · JFH
Abbott Laboratories
Chemistry · 68d
Cleared Nov 30, 1987
OLYMPUS PF-25 ULTRATHIN ANGIOSCOPE
K871517 · DQX
Olympus Corp.
Cardiovascular · 224d
Cleared Nov 30, 1987
OLYMPUS LUS ULTRASONIC LITHOTRIPTER
K873367 · FEO
Olympus Corp.
Gastroenterology & Urology · 101d
Cleared Nov 30, 1987
LIFECARE EXHALATION VALVE #06-699
K873570 · CBP
Lifecare Services, Inc.
Anesthesiology · 89d
Cleared Nov 30, 1987
GAIT-AID ORTHOPEDIC INSOLE
K874502 · IQI
Gait-Aid, Inc.
Physical Medicine · 28d
Cleared Nov 27, 1987
TELEPHONE DEFIBRILLATOR SYSTEM
K864257 · LDD
Medphone Corp.
Cardiovascular · 394d
Cleared Nov 27, 1987
URESIL THORA-FLO THORACENTESIS PROCEDURE KIT
K872948 · JOL
Uresil Corp.
General Hospital · 122d
Cleared Nov 27, 1987
CLOSED FOLEY CATHETER SYSTEM
K873288 · KNY
Todd Medical, Inc.
Gastroenterology & Urology · 102d