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
149281–149304 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 25, 1985
4013 NON CONDUCTIVE ANESTH. CIRCUIT W/BREATH-BAG
K851531 · CAI
Sigma Medical, Inc.
Anesthesiology · 9d
Cleared Apr 24, 1985
CORDIA HS ANTIBODY TYPING REAGENTS
K843751 · GQN
Cordis Corp.
Microbiology · 211d
Cleared Apr 24, 1985
LEMAITRE RETROGRADE VALVULOTOME-MANU-SURGICA INSTR
K850394 · DWS
Vascutech, Inc.
Cardiovascular · 82d
Cleared Apr 24, 1985
CHURCHILL HABER POINT NEEDLE ADMIN. SET
K850420 · FMI
Churchill Corp.
General Hospital · 79d
Cleared Apr 24, 1985
STREP-KIT
K850765 · JSJ
Culture Kits, Inc.
Microbiology · 58d
Cleared Apr 24, 1985
GENERAL DIAGNOSTICS AUGMENTIN 30MCG SUSCEP DISK
K851228 · JTN
Warner-Lambert Co.
Microbiology · 29d
Cleared Apr 24, 1985
BLUE SEAL II STERILIZATION POUCH
K851340 · FRG
American Sterilizer Co.
General Hospital · 21d
Cleared Apr 23, 1985
TF-II HIP PROSTHESIS
K843995 · KWL
Dow Corning Corp. Healthcare...
Orthopedic · 194d
Cleared Apr 23, 1985
PMS OPHTHALMOLOGY PACK-PMS EYE TRAY/PACK
K850050 · HOZ
Professional Medical Services
Ophthalmic · 105d
Cleared Apr 23, 1985
PROFILE FEMORAL HIP
K850055 · KWA
Depuy, Inc.
Orthopedic · 105d
Cleared Apr 23, 1985
HGM, INC. MEDICAL LASER ENDOCOAGULATOR MODEL 8-K
K850572 · HQF
Hgm, Inc.
Ophthalmic · 69d
Cleared Apr 22, 1985
VAN JON SUPER CLYSTER(KIT, ENEMA
K843792 · FCE
Van Jon Co.
Gastroenterology & Urology · 207d
Cleared Apr 22, 1985
EFFNER FIBER OPTIC CABLES FOR COLD LIGHT TRANSMISS
K844774 · FCR
Mecron Medical Products, Inc.
Gastroenterology & Urology · 133d
Cleared Apr 22, 1985
MODEL 518 & 519 ULTRASONOSCOPE W/DOPPLER
K844916 · IYO
Hoffrel Instruments, Inc.
Radiology · 125d
Cleared Apr 22, 1985
ALLOTROPAT/HEYLTEX CORP. BONE GRAFTING DENSE HYDRO
K850012 · LYC
Heyltex Corp.
Dental · 110d
Cleared Apr 22, 1985
ERIS URO-DIAGNOSTIC SYSTEM
K850169 · FFG
Eris Medical Technology
Gastroenterology & Urology · 96d
Cleared Apr 22, 1985
CAFFEIC ACID DISK
K850194 · JSF
Remel Co.
Microbiology · 94d
Cleared Apr 22, 1985
ENDOSOPIC STENE MANIPULATING BALLOON
K850489 · LQR
Mill-Rose Laboratory
Gastroenterology & Urology · 73d
Cleared Apr 22, 1985
KULZER DENTIN ADHESIVE
K850965 · EBF
Kulzer, Inc.
Dental · 45d
Cleared Apr 22, 1985
DENT-DR. VACU-FRAME
K851045 · EIE
Dent-Dr.
Dental · 39d
Cleared Apr 22, 1985
OPAQUER/BONDING AGENT
K851056 · KLE
Dentsply Intl.
Dental · 39d
Cleared Apr 22, 1985
T-SCREW
K851214 · HWC
Northeast Iowa Podiatry
Orthopedic · 27d
Cleared Apr 22, 1985
SEPTI-CHEK SCHAEDLER MED. BLOOD CULTURE BOTTLE-ROC
K851249 · JSJ
Roche Diagnostic Systems, Inc.
Microbiology · 26d
Cleared Apr 22, 1985
SEPTI-CHEK TSB W/SUCROSE BLOOD CULTURE BOTTLE-ROCH
K851250 · JSG
Roche Diagnostic Systems, Inc.
Microbiology · 26d