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
49897–49920 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 23, 2010
INFISTITCH FOR I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5
K101833 · OWB
Infimed, Inc.
Radiology · 22d
Cleared Jul 23, 2010
PROFAST+ ASSAY
K101855 · OQW
Gen-Probe Prodesse, Inc.
Microbiology · 22d
Cleared Jul 23, 2010
CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCH
K101866 · DXZ
Cryolife, Inc.
Cardiovascular · 21d
Cleared Jul 22, 2010
CPR MASK
K083418 · CBP
Firstar Healthcare Co., Ltd.
Anesthesiology · 611d
Cleared Jul 22, 2010
PANPAC VAGINAL PESSARY
K092981 · HHW
Panpac Medical Corporation
Obstetrics & Gynecology · 297d
Cleared Jul 22, 2010
YRNSORTIP OXIMANOMETER
K093981 · DXN
Cnoga Medical , Ltd.
Cardiovascular · 210d
Cleared Jul 22, 2010
IR EAR/FOREHEAD THERMOMETER MODE DX6635, DX6637, DTH1081
K100488 · FLL
Shenzhen Dongdixin Technology Co., Ltd.
General Hospital · 153d
Cleared Jul 22, 2010
IMPIX LUMBAR INTERBODY DEVICE
K100544 · MAX
Medicrea Technologies
Orthopedic · 147d
Cleared Jul 22, 2010
QUANTA DIODE LASER SYSTEM
K100558 · GEX
Quanta System Spa
General & Plastic Surgery · 143d
Cleared Jul 22, 2010
20 MMVIAL FLUID TRANSFER ADAPTER, MODEL 7E2500
K100640 · LHI
B.Braun Medical, Inc.
General Hospital · 139d
Cleared Jul 22, 2010
VENUS BASIC SPINAL FIXATION SYSTEM
K100706 · MNH
L & K Biomed Co., Ltd.
Orthopedic · 132d
Cleared Jul 22, 2010
ALEUTIAN IBF SYSTEM
K101302 · ODP
K2m, Inc.
Orthopedic · 73d
Cleared Jul 22, 2010
AUDIT MICROCV PROCALCITONIN LINEARITY
K101434 · MJX
Aalto Scientific, Ltd.
Microbiology · 62d
Cleared Jul 22, 2010
CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODES
K101576 · DRX
Team Innovations, Inc.
Cardiovascular · 45d
Cleared Jul 22, 2010
RTC-24 VP METERED DOSE INHALER ADAPTER, MODEL RTC 24-V
K101857 · CAF
Instrumentation Industries, Inc.
Anesthesiology · 20d
Cleared Jul 22, 2010
SOLARIS REUSABLE AND DISPOSABLE BLOOD PRESSURE CUFFS
K101972 · DXQ
Solaris Medical Technology, Inc.
Cardiovascular · 9d
Cleared Jul 21, 2010
SARGON NON-EXPANDABLE DENTAL IMPLANT
K082573 · DZE
Sargon Ent., Inc.
Dental · 684d
Cleared Jul 21, 2010
NES REPROCESSED VARICOSE VEIN RF CATHETER
K090661 · NUJ
Northeast Scientific, Inc.
General & Plastic Surgery · 496d
Cleared Jul 21, 2010
DIGITAL X-RAY IMAGING SYSTEM, MODEL DRC-1000
K092830 · KPR
VATECH Co., Ltd.
Radiology · 310d
Cleared Jul 21, 2010
VISCOPE, MODEL 100P,100S
K100531 · DQD
Hd Medical Services (India) Pvt.Ltd
Cardiovascular · 147d
Cleared Jul 21, 2010
SUPRA SCAN DELIVERY SYSTEM
K100678 · GEX
Quantel Medical
General & Plastic Surgery · 133d
Cleared Jul 21, 2010
IBA PROTON THERAPY SYSTEM, MODEL PROTEUS 235
K100766 · LHN
Ion Beam Applications S.A.
Radiology · 126d
Cleared Jul 21, 2010
ECT DIGITAL THERMOMETER
K101043 · FLL
Changshan Estar Electronics Co., Ltd.
General Hospital · 98d
Cleared Jul 21, 2010
JOINSOON ELECTRONICS MFG CO. LTD HIGH SPEED DIGITAL THERMOMETER, MODEL TC-001
K101232 · FLL
Joinsoon Electronics Mfg Co, Ltd.
General Hospital · 79d