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
38617–38640 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Mar 26, 2014
OP300
K133544 · OAS
Palodex Group OY
Radiology · 128d
Cleared Mar 26, 2014
CORGRIP
K133599 · KNT
Corpak Medsystems
Gastroenterology & Urology · 121d
Cleared Mar 26, 2014
ENCORE SYSTEM
K133680 · ORY
Siesta Medical, Inc.
Dental · 114d
Cleared Mar 26, 2014
EXSALT SD7 WOUND DRESSING WITH ADHESIVE BACKING
K133775 · FRO
Exciton Technologies, Inc.
General & Plastic Surgery · 104d
Cleared Mar 26, 2014
MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX...
K133807 · FLD
Gambro Renal Products, Inc.
Gastroenterology & Urology · 100d
Cleared Mar 26, 2014
AMIPLIVUE HSV 1&2 ASSAY
K140029 · OQO
Quidel Corporation
Microbiology · 79d
Cleared Mar 26, 2014
COLLAGEN TENDON SHEET-DDI (CTS-DDI)
K140300 · OWY
Rotation Medical, Inc.
Orthopedic · 48d
Cleared Mar 26, 2014
MONOTEX
K140415 · NBY
Riverpoint Medical
General & Plastic Surgery · 36d
Cleared Mar 26, 2014
PEREGRINE SYSTEM INFUSION CATHETER
K140637 · KRA
Ablative Solutions, Inc.
Cardiovascular · 14d
Cleared Mar 25, 2014
NOVA STAT PROFILE PRIME CCS ANALYZER SYSTEM
K131703 · CHL
Nova Biomedical Corporation
Chemistry · 287d