FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
38017–38040 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 28, 2014
ITOTAL CRUCIATE RETAINING KNEE REPLACMENT SYSTEM
K133560 · JWH
Conformis, Inc.
Orthopedic · 128d
Cleared Mar 28, 2014
EXTREMITY MEDICAL HAMMERTOE DEVICE
K133636 · HWC
Extremity Medical, LLC
Orthopedic · 122d
Cleared Mar 28, 2014
OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS)
K133940 · HRY
Biomet UK, Ltd.
Orthopedic · 95d
Cleared Mar 28, 2014
CORONIS 5MP
K133984 · LLZ
Barco N.V.
Radiology · 92d
Cleared Mar 28, 2014
ARIETTA 70/ARIETTA S70/ARIETTA V70 DIAGNOSTIC ULTRASOUND SCANNER
K134016 · IYN
Hitachi Aloka Medical,Ltd. (Hitachi...
Radiology · 88d
Cleared Mar 28, 2014
AXERA 2 ACCESS SYSTEM
K140201 · DYB
Arstasis, Inc.
Cardiovascular · 60d
Cleared Mar 27, 2014
PATHFAST CTNL CALIBRATORS
K130603 · JIT
Mitsubishi Chemical Medience Corporation
Chemistry · 385d
Cleared Mar 27, 2014
SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, RAYSERT SINGLE USE SOFT TIPPED...
K132002 · MSS
Rayner Intraocular Lenses , Ltd.
Ophthalmic · 269d
Cleared Mar 27, 2014
BIOMET ACCESS SYSTEM
K132373 · PDQ
Biomet Spine (Aka Ebi, LLC)
Neurology · 240d
Cleared Mar 27, 2014
VENTED MILLEX -GV, CATHIVEX -GV
K133004 · BSN
Merck Millipore , Ltd.
Anesthesiology · 183d
Cleared Mar 27, 2014
CROSSFUSE II CORONAL TAPER, CROSSFUSE II HYPERLORDOTIC
K133455 · MAX
Pioneer Surgical Technology, Inc.
Orthopedic · 135d
Cleared Mar 27, 2014
SINGLE USE STERILE SYRINGE WITH NEEDLE
K133493 · FMF
Jiangxi Kelun Medical Devices...
General Hospital · 133d
Cleared Mar 27, 2014
LEXIPLIANT DILATOR SHEATH SET
K133631 · DRE
Spectranetics Corporation
Cardiovascular · 121d
Cleared Mar 27, 2014
PDE-NEO
K133719 · IZI
Hamamatsu Photonics K.K.
Radiology · 112d
Cleared Mar 27, 2014
FLOWER REAR FOOT PLATING SET, FLOWER CALCANEUS PLANTING SET, FLOWER REARFOOT...
K133930 · HRS
Flower Orthopedics Corporation
Orthopedic · 94d
Cleared Mar 27, 2014
S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM
K140106 · OVD
Renovis Surgical Technologies, Inc.
Orthopedic · 71d
Cleared Mar 27, 2014
MANDREL GUIDEWIRE
K140485 · DQX
Lake Region Medical
Cardiovascular · 29d
Cleared Mar 27, 2014
ELECSYS PRECICONTROL TS
K140534 · JJX
Roche Diagnostics
Chemistry · 23d
Cleared Mar 26, 2014
WHIP MIX PREPPIES PLUS
K131760 · EJR
Whip-Mix Corp.
Dental · 282d
Cleared Mar 26, 2014
AMICO DH-W35 OPHTHALMOSCOPE SERIES
K131939 · HLI
Amico Diagnostic Incorporated
Ophthalmic · 272d
Cleared Mar 26, 2014
INTELLIVUE CL RESPIRATION POD
K132320 · BZQ
Philips Medizinsysteme Boeblingen...
Anesthesiology · 244d
Cleared Mar 26, 2014
VENTRAIN
K132759 · BTL
Dolphys Medical B.V.
Anesthesiology · 203d
Cleared Mar 26, 2014
RESOLUTIONMD MOBILE
K133508 · LLZ
Calgary Scientific, Inc.
Radiology · 132d
Cleared Mar 26, 2014
TOTAL ACROSS
K133539 · DQY
Medtronic Vascular
Cardiovascular · 128d