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

Filters: Cleared only ×
176,076 results
70969–70992 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 05, 2003
PERIOGLAS PLUS - SETTABLE BONE GRAFT SUBSTITUTE
K031073 · LYC
Novabone Products, LLC
Dental · 215d
Cleared Nov 05, 2003
VITOSS-FILLED CARTRIDGE
K032130 · MQV
Orthovita, Inc.
Orthopedic · 117d
Cleared Nov 05, 2003
INVISIJECT RESUSABLE AUTO-INJECTOR
K032425 · KZH
Biogen
General Hospital · 91d
Cleared Nov 05, 2003
ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC)
K032439 · MKJ
Zoll Medical Corp
Cardiovascular · 90d
Cleared Nov 05, 2003
MULTILINK
K032470 · EMA
Ivoclar Vivadent, Inc.
Dental · 86d
Cleared Nov 05, 2003
VERSYS BEADED FULLCOAT CALCAR HIP PROSTHESIS
K033034 · LPH
Zimmer, Inc.
Orthopedic · 37d
Cleared Nov 05, 2003
SYNTHES (USA) CANNULATED TITANIUM HUMERAL NAIL SYSTEM
K033071 · JDS
Synthes (Usa)
Orthopedic · 37d
Cleared Nov 05, 2003
ECHOCONNEX COMMUNICATOR
K033093 · LLZ
Connexmd
Radiology · 37d
Cleared Nov 05, 2003
MEDIC COLON MODEL, RELEASE 1
K033102 · JAK
Medicsight
Radiology · 37d
Cleared Nov 05, 2003
WRISTJACK ORIF SYSTEM, WRISTJACK ORIF SYSTEM, NON-STERILE, MODELS CFD-347,...
K033112 · KTT
Hand Biomechanics Lab, Inc.
Orthopedic · 36d
Cleared Nov 05, 2003
HOFFMANN II PELVIC CLAMP
K033145 · LXT
Howmedica Osteonics Corp.
Orthopedic · 36d
Cleared Nov 05, 2003
SYNTHES REPROCESSED EXTERNAL FIXATION DEVICES
K033158 · KTT
Synthes (Usa)
Orthopedic · 36d
Cleared Nov 05, 2003
HOLOGIC QDR EXPLORER X-RAY BONE DENSITOMETER, MODEL EXPLORER
K033224 · KGI
Hologic, Inc.
Radiology · 30d
Cleared Nov 05, 2003
LACTOSORB TIBIAL L-15 SCREW AND WASHER
K033233 · HWC
Biomet, Inc.
Orthopedic · 30d
Cleared Nov 05, 2003
MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM
K033247 · DXT
Medrad, Inc.
Cardiovascular · 29d
Cleared Nov 05, 2003
VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK
K033300 · DDR
Ortho-Clinical Diagnostics, Inc.
Chemistry · 22d
Cleared Nov 05, 2003
SELECTIVA SB GUIDEWIRE
K033321 · DQX
Neometrics, Inc.
Cardiovascular · 21d
Cleared Nov 05, 2003
VIATRONIX V3D VASCULAR, REVISION 1.0
K033361 · LLZ
Viatronix, Inc.
Radiology · 15d
Cleared Nov 05, 2003
TITAN ULTRASOUND SYSTEM, SONOSITE ILOOK 25 ULTRASOUND SYSTEM, 180PLUS...
K033367 · IYN
Sonosite,Inc.
Radiology · 15d
Cleared Nov 05, 2003
SELECT 3D ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE AND SELECT CAP...
K033416 · DWF
Medtronic Perfusion Systems
Cardiovascular · 9d
Cleared Nov 04, 2003
THERATEARS CONTACT LENS COMFORT DROPS
K032481 · LPN
Advanced Vision Research, Inc.
Ophthalmic · 84d
Cleared Nov 04, 2003
BISCEM GI
K032597 · EMA
Bisco, Inc.
Dental · 74d
Cleared Nov 04, 2003
VITEK 2 GRAM NEGATIVE GATIFLOXACIN
K032788 · LON
bioMerieux, Inc.
Microbiology · 57d
Cleared Nov 04, 2003
GIARDIA II
K033274 · MHI
Techlab, Inc.
Microbiology · 25d