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
44041–44064 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 19, 2012
SYNTHES RADIAL HEAD PROSTHESIS SYSTEM
K112030 · KWI
Synthes (Usa), LLC
Orthopedic · 340d
Cleared Jun 19, 2012
I-ROOT 100
K112508 · LQY
S-Denti Co., Ltd.
Dental · 294d
Cleared Jun 19, 2012
MICROEEG SYSTEM
K112817 · GWQ
Bio-Signal Group Corporation
Neurology · 265d
Cleared Jun 19, 2012
SODIUM CHLORDE INHALATION SOLUTION, 0.9% USP-3ML
K113033 · CAF
Nephron Pharmaceuticals Corp.
Anesthesiology · 251d
Cleared Jun 19, 2012
HEALITE II SYSTEM
K113668 · ILY
Lutronic Corporation
Physical Medicine · 189d
Cleared Jun 19, 2012
TROJAN HER PLEASURE (RIBBED) ECSTASY LATEX CONDOM WITH LUBRICANT
K120286 · HIS
Church & Dwight Co., Inc.
Obstetrics & Gynecology · 140d
Cleared Jun 19, 2012
LINEAR POROUS COATED HIP STEM, SIZE 5
K121024 · LPH
Encore Medical, L.P.
Orthopedic · 76d
Cleared Jun 19, 2012
OP SPINE SYSTEM
K121250 · OSH
OrthoPediatrics Corp.
Orthopedic · 55d
Cleared Jun 18, 2012
CIRRUS PHOTO
K112184 · OBO
Carl Zeiss Meditec, Inc.
Ophthalmic · 326d
Cleared Jun 18, 2012
MATRIXBRUSH ENDOMETRIAL SAMPLER
K112763 · HFE
Post Oak Innovations, Inc.
Obstetrics & Gynecology · 270d
Cleared Jun 18, 2012
BEAUTICEM SA
K120159 · EMA
Shofu Dental Corporation
Dental · 151d
Cleared Jun 18, 2012
CMI IMPLANT IS II ACTIVE
K120503 · DZE
Neobiotech Co., Ltd.
Dental · 118d
Cleared Jun 18, 2012
ALPHA ORTHOPAEDICS AT2 SYSTEM
K120527 · GEI
Alpha Orthopaedics, Inc.
General & Plastic Surgery · 117d
Cleared Jun 18, 2012
SYNTHES VA LCP ANKLE TRAUMA SYSTEM
K120854 · HRS
Synthes (Usa)
Orthopedic · 89d
Cleared Jun 18, 2012
CARDIQ XPRESS 2.0 WITH SNAPSHOT FREEZE OPTION CARDIQ XPRESS 2.0 REVEAL
K120910 · JAK
GE Medical Systems SCS
Radiology · 84d
Cleared Jun 15, 2012
SIGNATURE PLANNER,SIGNATURE GUIDES
K111863 · JDI
Materialise NV
Orthopedic · 351d
Cleared Jun 15, 2012
AUDIT MICROLQ SPINAL FLUID CONTROL
K112742 · JJY
Aalto Scientific, Ltd.
Chemistry · 268d
Cleared Jun 15, 2012
IVENT101
K112754 · CBK
Versamed Medical Systems , Ltd.
Anesthesiology · 268d
Cleared Jun 15, 2012
READY VIEW
K113456 · LLZ
Ge Healthcare (Ge Medical Systems Scs)
Radiology · 207d
Cleared Jun 15, 2012
DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM
K113613 · IYN
Shantou Institute of Ultrasonic...
Radiology · 192d
Cleared Jun 15, 2012
TM-400 DEVICE
K120203 · MAX
Zimmer Trabecular Metal Technology, Inc.
Orthopedic · 144d
Cleared Jun 15, 2012
DURAGEN SECURE DURAL REGNERATION MATRIX
K120600 · GXQ
Integra Life Sciences
Neurology · 108d
Cleared Jun 15, 2012
BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER...
K120823 · FJK
Fresenius Medical Care North America,...
Gastroenterology & Urology · 88d
Cleared Jun 15, 2012
GREENLIGHT MOXY FIBER OPTIC
K120870 · GEX
American Medical Systems
General & Plastic Surgery · 85d