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

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176,076 results
65473–65496 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 11, 2005
REPROCESSED RELOADABLE CUTTERS, STAPLERS, AND APPLIERS
K033578 · NLL
Clearmedical, Inc.
General & Plastic Surgery · 606d
Cleared Jul 11, 2005
REPROCESSED MULTIPLE CLIP APPLIERS
K033579 · NMJ
Clearmedical, Inc.
General & Plastic Surgery · 606d
Cleared Jul 11, 2005
SEPRAGEL ENT BIORESORBABLE PACKING/STENT
K043035 · KHJ
Genzyme Corporation
Ear, Nose, Throat · 250d
Cleared Jul 11, 2005
HEMORAM/AGGRAM ANALYZER
K050053 · JPA
Helena Laboratories
Hematology · 182d
Cleared Jul 11, 2005
THERALASE TLC-1000 THERAPEUTIC MEDICAL LASER SYSTEM
K050342 · NHN
Theralase, Inc.
Physical Medicine · 150d
Cleared Jul 11, 2005
GONGDONG DISPOSABLE VAGINAL SPECULUM
K050887 · HIB
Zhejiang Gongdong Medical Plastic...
Obstetrics & Gynecology · 95d
Cleared Jul 11, 2005
MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT
K050960 · JLX
Wallac OY
Chemistry · 84d
Cleared Jul 11, 2005
ZUTRON COLONOSCOPE STIFFENING DEVICE
K051068 · FDF
Zutron Medical
Gastroenterology & Urology · 76d
Cleared Jul 11, 2005
DIMENSION VISTA INTEGRATED SYSTEM
K051087 · JJE
Dade Behring, Inc.
Chemistry · 74d
Cleared Jul 11, 2005
SOLCO 4CIS GENERAL PLATE SYSTEM
K051155 · HRS
Solco Biomedical Co., Ltd.
Orthopedic · 68d
Cleared Jul 11, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CLINDAMYCIN (STREP) 0.03125 -4 UG/ML
K051272 · LON
Becton, Dickinson & CO
Microbiology · 55d
Cleared Jul 11, 2005
ROI FUSION RODS & PLATES
K051309 · HWC
Reiley Orthopaedics, Inc.
Orthopedic · 53d
Cleared Jul 11, 2005
MODIFICATION TO: NUVASIVE NEUROVISION JJB SYSTEM
K051384 · GWF
Nuvasive, Inc.
Neurology · 45d
Cleared Jul 11, 2005
HUMERAL HEAD PLATE WITH ANGULAR STABILITY
K051412 · HRS
I.T.S. Implantat-Technologie-Systeme...
Orthopedic · 41d
Cleared Jul 11, 2005
ENDOVENTIONS ALIMAXX-E ESOPHAGEAL STENT SYSTEM
K051621 · ESW
Alveolus, Inc.
Gastroenterology & Urology · 21d
Cleared Jul 11, 2005
ROCHE ELECSYS TROPONIN T STAT (SHORT TURNAROUND TIME)
K051752 · MMI
Roche Diagnostics
Chemistry · 12d
Cleared Jul 08, 2005
SINGLE USE BALLOON DILATOR MAXPASSTM
K050502 · FGE
Olympus Winter & Ibe GmbH
Gastroenterology & Urology · 130d
Cleared Jul 08, 2005
PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEM
K051108 · CFJ
Abaxis, Inc.
Chemistry · 67d
Cleared Jul 08, 2005
ESPRIT VENTILATOR NEONATAL OPTION, MODEL V1000
K051262 · CBK
Respironics California, Inc.
Anesthesiology · 53d
Cleared Jul 08, 2005
UNITY NETWORK ID
K051518 · MWI
Ge Medical Systems Information...
Cardiovascular · 30d
Cleared Jul 08, 2005
MONARC + SUBFASCIAL HAMMOCK, MODEL 72404193
K051530 · OTN
American Medical Systems, Inc.
Gastroenterology & Urology · 29d
Cleared Jul 08, 2005
IMASK, MODELS 100, 200 AND 300
K051559 · BZD
Vital Signs Colorado, Inc.
Anesthesiology · 25d
Cleared Jul 08, 2005
THE ART OF INTIMACY RESPONSE PERSONAL LUBRICANT
K051668 · NUC
Goodmark USA, Inc.
Obstetrics & Gynecology · 16d
Cleared Jul 07, 2005
BD DIRECTIGEN EZ FLU A + B
K042472 · PSZ
Becton, Dickinson & CO
Microbiology · 300d