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

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176,076 results
54649–54672 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 09, 2009
180W CERELAS D 980NM DIODE LASER, MODEL D180
K083682 · GEX
Biolitec, Inc.
General & Plastic Surgery · 29d
Cleared Jan 09, 2009
PANASIL INITIAL CONTACT AND PANASIL TRAY
K083701 · ELW
Kettenbach GmbH & Co. KG
Dental · 25d
Cleared Jan 09, 2009
ISOLAZ
K083730 · GEX
Aesthera Corporation
General & Plastic Surgery · 24d
Cleared Jan 08, 2009
PAIN VISION, MODEL PS-2100
K072882 · LLN
Osachi Co., Ltd.
Neurology · 457d
Cleared Jan 08, 2009
RAPIDSENSE DRUGS OF ABUSE PHENCYCLIDINE (PCP) 25 DEVICE WITH MODELS 900-0054
K080431 · LCM
Quantrx Biomedical Corporation
Toxicology · 324d
Cleared Jan 08, 2009
MYGLUCOHEALTH GLUCOSE MONITORING SYSTEMS
K081703 · NBW
Entra Health Systems, Ltd.
Chemistry · 205d
Cleared Jan 08, 2009
ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORS
K081895 · LCP
Siemens Medical Solutions Diagnostics
Chemistry · 189d
Cleared Jan 08, 2009
WORLDWIDE MEDICAL TECHNOLOGIES ANCHOR MARKER, MARKER STRAND AND MARKER
K083274 · KXK
Biocompatibles, Inc.
Radiology · 63d
Cleared Jan 08, 2009
KUBTEC XPERT 20
K083510 · KPR
Kub Technologies, Inc.
Radiology · 43d
Cleared Jan 08, 2009
MODIFICATION TO ZENIEVA
K083721 · NAE
River'S Edge Pharmaceuticals, LLC
General & Plastic Surgery · 24d
Cleared Jan 07, 2009
NEO-VAGINA SURGERY SET AND ACCESSORIES
K071754 · HDX
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 559d
Cleared Jan 07, 2009
VERIFY SIRIUS BIOLOGICAL INDICATOR CHALLENGE PACK
K073618 · FRC
STERIS Corporation
General Hospital · 378d
Cleared Jan 07, 2009
REFLEXION HD HIGH-DENSITY MAPPING CATHETER
K080179 · DRF
St Jude Medical
Cardiovascular · 349d
Cleared Jan 07, 2009
CALHEALTH, INC., FINGER BLOOD PRESSURE MONITOR, MDMOUSE
K081924 · DXN
Calhealth, Inc.
Cardiovascular · 184d
Cleared Jan 07, 2009
POWDER FREE BLUE PATIENT NITRILE EXAMINATION GLOVE
K082598 · LZA
Tangshan Zhonghong Pulin Group Co., Ltd.
General Hospital · 121d
Cleared Jan 07, 2009
G1B PULSE OXIMETER
K082789 · DQA
General Meditech, Inc.
Anesthesiology · 106d
Cleared Jan 07, 2009
A-DEC/W&H PROFIN RECIPROCATING CONTRA-ANGLE HANDPIECE ATTACHMENT
K082827 · EFB
A-Dec, Inc.
Dental · 104d
Cleared Jan 07, 2009
BIOMERIX COMPOSITE SURGICAL MESH, MODEL SMNR-0510 AND SMNR-1215
K082941 · FTL
Biomerix Corporation
General & Plastic Surgery · 97d
Cleared Jan 07, 2009
PERI-LOC BONE PLATING AND SCREW SYSTEM
K083032 · HRS
Smith & Nephew, Inc.
Orthopedic · 89d
Cleared Jan 06, 2009
VARIABLE LASSO NAV CATHETER, MODELS: D-1290-01, D-1290-02
K081258 · DRF
Biosense Webster, Inc.
Cardiovascular · 249d
Cleared Jan 06, 2009
ENTACT SEPTAL STAPLER, MODEL 610-00100
K082750 · OLL
Entrigue Surgical, Inc.
Ear, Nose, Throat · 109d
Cleared Jan 06, 2009
RENEGADE WHEELCHAIR
K082857 · IQC
Alpha One
Physical Medicine · 99d
Cleared Jan 06, 2009
IROOT BP, MODEL IRBP 4609
K082943 · KIF
Innovative Bioceramix, Inc.
Dental · 96d
Cleared Jan 06, 2009
ULTIMA FIVE
K083494 · GZJ
Pain Management Technologies
Neurology · 42d