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
56329–56352 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 20, 2008
PRO TENS, MODEL WL-240 RX
K080304 · GZJ
Well-Life Healthcare Limited
Neurology · 136d
Cleared Jun 20, 2008
MAKO SURGICAL CORP. UNICONDYLAR KNEE IMPLANT SYSTEM II
K080368 · HSX
Mako Surgical Corp.
Orthopedic · 129d
Cleared Jun 20, 2008
DR VISION NEO, DR VISION DOU
K080614 · KPR
Almana Medical Imaging
Radiology · 107d
Cleared Jun 20, 2008
MERCURY VCO2 MODULE WITH CAPNOSTAT 5
K080652 · BZK
Respironics Novametrix, LLC
Anesthesiology · 105d
Cleared Jun 20, 2008
PAJUNK INFILTRALONG WOUND INFILTRATION CATHETER KIT
K080675 · BSO
PAJUNK GmbH Medizintechnologie
Anesthesiology · 102d
Cleared Jun 20, 2008
SMARTBURS
K080687 · EJL
S.S. White Burs, Inc.
Dental · 101d
Cleared Jun 20, 2008
MACS CPAP SYSTEM
K080692 · BTL
Airon Corporation
Anesthesiology · 101d
Cleared Jun 20, 2008
CROSSER LP SYSTEM
K080765 · DQX
Flowcardia, Inc.
Cardiovascular · 94d
Cleared Jun 20, 2008
TINA-QUANT CYSTATIN C, CALIBRATOR F.A.S. CYSTATIN C AND CYSTATIN C...
K080811 · NDY
Roche Diagnostics Corp.
Chemistry · 88d
Cleared Jun 20, 2008
VELOCITYAIS, VELOCITY AI, VELOCITYVX, VELOCITYRT, V-RESPONSE
K081076 · LLZ
Velocity Medical Solutions, LLC
Radiology · 65d
Cleared Jun 20, 2008
OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500
K081094 · MEC
Olympic Medical Corp.
General Hospital · 64d
Cleared Jun 20, 2008
MODIFICATION TO DOUBLEPLAY SUTURE ANCHOR
K081428 · HWC
Biocomposites, Ltd.
Orthopedic · 30d
Cleared Jun 20, 2008
HORIZON XVU
K081484 · DQK
Mennen Medical , Ltd.
Cardiovascular · 23d
Cleared Jun 20, 2008
ACCELA SYSTEM
K081578 · GEX
Genesis Biosystems, Inc.
General & Plastic Surgery · 15d
Cleared Jun 20, 2008
ENDOSCOPY VIDEO CAMERA SYSTEM
K081585 · FET
Vision Systems Group, A Division of...
Gastroenterology & Urology · 15d
Cleared Jun 20, 2008
MODIFICATION TO COOLTOUCH, MODELS LC225 AND COOLLIPO
K081628 · GEX
New Star Lasers, Inc.
General & Plastic Surgery · 10d
Cleared Jun 19, 2008
DUREX SYNTHETIC POLYISOPRENE MALE CONDOM
K072169 · MOL
Ssl Americas, Inc.
Obstetrics & Gynecology · 318d
Cleared Jun 19, 2008
PRONTOSAN WOUND IRRIGATION SOLUTION
K072876 · FRO
B.Braun Medical, Inc.
General & Plastic Surgery · 254d
Cleared Jun 19, 2008
MULTIGENT CREATININE (ENZYMATIC) ASSAY
K073634 · JFY
SENTINEL CH. SpA
Chemistry · 176d
Cleared Jun 19, 2008
MICRO-TOUCH NITRAFREE
K080536 · LZA
Ansell Healthcare Products, LLC
General Hospital · 113d
Cleared Jun 19, 2008
ESTELITE SIGMA QUICK
K080940 · EBF
Tokuyama Dental Corporation
Dental · 77d
Cleared Jun 19, 2008
WOUNDSTAT
K081183 · QSY
Traumacure, Inc.
General & Plastic Surgery · 55d
Cleared Jun 19, 2008
LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE
K081221 · DWA
Levitronix, LLC
Cardiovascular · 50d
Cleared Jun 19, 2008
RELIMESH
K081327 · FTL
Herniamesh S.R.L.
General & Plastic Surgery · 38d