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
38665–38688 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 21, 2014
SAVE II, SAVE II BASIC
K131877 · BTL
Automedx, Inc.
Anesthesiology · 269d
Cleared Mar 21, 2014
APOTECA DUG COMPOUNDING DOSING DEVICE,APOTECA I.V. TRANSFER SET
K132011 · FMF
Aea Srl
General Hospital · 263d
Cleared Mar 21, 2014
AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL
K132031 · CHH
Axis-Shield Poc AS
Chemistry · 246d
Cleared Mar 21, 2014
ELIBRA SOFT-TISSUE FORCE SENSOR
K132104 · ONN
Kamm & Associates
Orthopedic · 256d
Cleared Mar 21, 2014
KERATOR
K132144 · DZE
LK Consulting Group USA, Inc.
Dental · 253d
Cleared Mar 21, 2014
NS 2500 HOLMIUM LASER SYSTEM
K132607 · GEX
New Star Lasers, Inc.
General & Plastic Surgery · 213d
Cleared Mar 21, 2014
DISCOVERY PET/CT 710
K133657 · KPS
Ge Medical Systems, LLC
Radiology · 114d
Cleared Mar 21, 2014
EYE SECRET 55 UV ASPHERIC (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS
K133735 · LPL
Yung Sheng Optical Co., Ltd.
Ophthalmic · 102d
Cleared Mar 21, 2014
NOVA FA DR SYSTEM
K133782 · MQB
Sedecal., Sa.
Radiology · 99d
Cleared Mar 21, 2014
DORNOCH DUO SUCTION CART WITH: DL2800 LID, CL500 LID, DORNOCH QUAD SUCTION...
K133786 · JCX
Dornoch Medical Systems, Inc.
General & Plastic Surgery · 99d
Cleared Mar 21, 2014
RANGE, SPINAL SYSTEM, EVEREST SPINAL SYSTEM
K133944 · NKB
K2m, Inc.
Orthopedic · 88d
Cleared Mar 21, 2014
TERASON USMART3200 AND BENQ UP200ULTRASOUND SYSTEM
K140524 · IYN
Teratech Corp.
Radiology · 17d
Cleared Mar 20, 2014
IM60/IM70 PATIENT MONITOR
K131971 · MHX
Edan Instruments, Inc.
Cardiovascular · 265d
Cleared Mar 20, 2014
TRC-PEX, RADIC-SEALER
K132123 · KIF
Km Corporation
Dental · 253d
Cleared Mar 20, 2014
VARIOGUIDE DRILL KIT
K132436 · HBE
Mri Interventions, Inc.
Neurology · 227d
Cleared Mar 20, 2014
CAIR DRIVE, NEUTRACLEAR
K133073 · FPA
Cair Lgl
General Hospital · 171d
Cleared Mar 20, 2014
ZIRTOUGH
K133211 · EIH
Kuraray Noritake Dental, Inc.
Dental · 153d
Cleared Mar 20, 2014
DIGORA OPTIME
K133231 · MUH
Instrumentarium Dental, Palodex Group OY
Radiology · 150d
Cleared Mar 20, 2014
ET LIGHTSHEER 1060, HIGH SPEED LIGHTSHEER 1060
K133319 · GEX
Lumenis, Ltd.
General & Plastic Surgery · 143d
Cleared Mar 20, 2014
STRYKER PEDIATRIC MANDIBLE DISTRACTOR
K133398 · MQN
Stryker
Dental · 134d
Cleared Mar 20, 2014
CAMBER SPINE COVERIS CERVICAL CAGE
K133529 · ODP
Camber Spine
Orthopedic · 125d
Cleared Mar 20, 2014
INTRA-LOCK DENTAL IMPLANTS
K133613 · DZE
Intra-Lock International, Inc.
Dental · 115d
Cleared Mar 20, 2014
TYBER MEDICAL TRAUMA SCREW
K133842 · HWC
Tyber Medical, LLC
Orthopedic · 92d
Cleared Mar 20, 2014
FLOW-I ANESTHESIA SYSTEM C20, C30 & C40
K133958 · BSZ
Maquet Critical Care AB
Anesthesiology · 86d