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
57433–57456 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 08, 2008
SAVVY LONG AND SLEEK PERIPHERAL TRANSLUMINAL ANGIOPLASTY (PTA) CATHETERS
K072947 · LIT
ClearStream Technologies , Ltd.
Cardiovascular · 113d
Cleared Feb 08, 2008
REUSABLE HEADREST WITH NASAL SEAL
K072993 · BZD
Aeiomed, Inc.
Anesthesiology · 108d
Cleared Feb 08, 2008
MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER AND ACCESSORIES
K073024 · DQA
Masimo Corporation
Anesthesiology · 105d
Cleared Feb 08, 2008
SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM, SAFE-CROSS(R)...
K073162 · DQX
Kensey Nash Corporation
Cardiovascular · 91d
Cleared Feb 08, 2008
HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE
K073188 · FMI
Smiths Medical Asd, Inc.
General Hospital · 87d
Cleared Feb 08, 2008
VASCULAR PATHWAYS RIVS RAPID INTRAVASCULAR CATHETER START SYSTEM
K073241 · FOZ
Vascular Pathways
General Hospital · 84d
Cleared Feb 08, 2008
LED PRO SEAL
K073243 · EBD
Reliance Orthodontic Products, Inc.
Dental · 81d
Cleared Feb 08, 2008
BIOHORIZONS INTERNAL IMPLANT SYSTEM
K073268 · DZE
BioHorizons Implant Systems, Inc.
Dental · 80d
Cleared Feb 08, 2008
DYNESYS TOP-LOADING SPINAL SYSTEM
K073347 · NQP
Zimmer Spine, Inc.
Orthopedic · 71d
Cleared Feb 08, 2008
TALKING CLINICAL ELECTRONIC THERMOMETER, MODELS DX6623B, DT1031 AND DT1041
K073366 · FLL
Shenzhen Dongdixin Technology Co., Ltd.
General Hospital · 70d
Cleared Feb 08, 2008
GRIND GUARD
K073446 · OBR
Archtek, Inc.
Dental · 63d
Cleared Feb 08, 2008
APLIO ARTIDA, MODEL SSH-880CV DIAGNOSTIC ULTRASOUND SYSTEM
K080160 · IYN
Toshiba America Medical Systems, In.C
Radiology · 16d
Cleared Feb 08, 2008
HEARTSTRING III PROXIMAL SEAL SYSTEM
K080169 · DXC
Guidant Corporation, Cardiac Surgery
Cardiovascular · 15d
Cleared Feb 08, 2008
STAR 55
K080173 · MWI
Larsen & Toubro Limited
Cardiovascular · 15d
Cleared Feb 08, 2008
FLOR-OPAL VARNISH WHITE
K080249 · LBH
Ultradent Products, Inc.
Dental · 8d
Cleared Feb 07, 2008
HUMAN HEART VALVE, CRYOVALVE SG
K033484 · OHA
Cryolife, Inc.
Cardiovascular · 1556d
Cleared Feb 07, 2008
SANATMETAL NAILS AND PINS
K070761 · HSB
Sanatmetal Mfr. of...
Orthopedic · 324d
Cleared Feb 07, 2008
RK EPIDURAL NEEDLE
K072005 · BSP
Epimed International
Anesthesiology · 199d
Cleared Feb 07, 2008
INTUITIVE SURGICAL DA VINCI AND DA VINCI S SURGICAL SYSTEM AND ENDOSCOPIC...
K072627 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 143d
Cleared Feb 07, 2008
SYNGO DUAL ENERGY WITH EXTENDED FUNCTIONALLY
K073003 · JAK
Siemens Medi Cal Solutions, Inc.
Radiology · 106d
Cleared Feb 07, 2008
ANCHORAGE CLOSURE DEVICE
K073096 · GAT
Epitek, Inc.
General & Plastic Surgery · 98d
Cleared Feb 07, 2008
CIMPLICITY SPINAL SYSTEM
K073320 · ODP
Spine Smith Partners L.P.
Orthopedic · 73d
Cleared Feb 07, 2008
PROSTIM 1000/2000
K073438 · GZJ
Bio Protech, Inc.
Neurology · 62d
Cleared Feb 07, 2008
SANARUS V2 TREATMENT SYSTEM
K073533 · GEH
Sanarus Medical, Inc.
General & Plastic Surgery · 52d