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
71809–71832 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 20, 2003
ELECYS SHBG CALCHECK
K031698 · JJX
Roche Diagnostics Corp.
Chemistry · 79d
Cleared Aug 20, 2003
SAPPHIRE DETACHABLE FIBER COILS
K031852 · HCG
Micro Therapeutics, Inc.
Neurology · 65d
Cleared Aug 20, 2003
ELECSYS PRECICONTROL TROPONIN T
K031990 · JJX
Roche Diagnostics Corp.
Toxicology · 54d
Cleared Aug 20, 2003
TISSUELINK FLOATING BALL MODEL 23-201-1
K032132 · GEI
Tissuelink Medical, Inc.
General & Plastic Surgery · 40d
Cleared Aug 20, 2003
OMNILIGHT FLUORESCENT PULSED LIGHT SYSTEM
K032191 · GEX
Luxsano AB
General & Plastic Surgery · 34d
Cleared Aug 20, 2003
AESCULAP YASARGIL ANEURYSM CLIP PHYNOX BOOSTER CLIP
K032198 · HCH
Aesculap, Inc.
Neurology · 33d
Cleared Aug 20, 2003
MODIFICATION TO VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT
K032204 · GEX
Vascular Solutions, Inc.
General & Plastic Surgery · 33d
Cleared Aug 20, 2003
COBRA COOLED SURGICAL PROBE, MODEL M004159670
K032207 · GEI
Boston Scientific Corp
General & Plastic Surgery · 33d
Cleared Aug 20, 2003
EP-WORKMATE WITH RPM SYSTEM
K032225 · DQK
Ep Medsystems
Cardiovascular · 30d
Cleared Aug 20, 2003
DESIGNS FOR VISION FIBEROPTIC LIGHT
K032283 · GDB
Designs For Vision, Inc.
Gastroenterology & Urology · 27d
Cleared Aug 19, 2003
NX SYSTEM
K030222 · DRG
American Telecare, Inc.
Cardiovascular · 209d
Cleared Aug 19, 2003
ADVISOR, MODEL 9200
K030407 · CCK
Bci, Inc.
Anesthesiology · 193d
Cleared Aug 19, 2003
MIRAGE VISTA MASK
K031047 · BZD
Resmed, Ltd.
Anesthesiology · 139d
Cleared Aug 19, 2003
ELECTRO NEUROMUSCULAR STIMULATOR, MODEL BMLS03-1
K031427 · IPF
Biomedical Life Systems, Inc.
Physical Medicine · 105d
Cleared Aug 19, 2003
SIEMENS INFINITY MODULAR MONITORS, MODELS SC 7000, SC 9000XL AND SC 8000 WITH...
K031433 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 105d
Cleared Aug 19, 2003
PITANGA
K031489 · GEX
Syneron Medical, Ltd.
General & Plastic Surgery · 99d
Cleared Aug 19, 2003
SYNDEO PCA SYRINGE PUMP, MODEL 2L3113
K031566 · MEA
Baxter Healthcare Corp
General Hospital · 92d
Cleared Aug 19, 2003
SIROTORQUE L
K031584 · EBW
Sirona Dental Systems GmbH
Dental · 90d
Cleared Aug 19, 2003
MEDTRONIC MINIMED PARADIGM POLYFIN QR, MODEL MMT 312L AND 312S
K031917 · FPA
Medtronic Minimed
General Hospital · 57d
Cleared Aug 19, 2003
GLOVETEX POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, NON-STERILE
K032010 · LZA
Pt. Wrp Buana Multicorpora
General Hospital · 50d
Cleared Aug 19, 2003
GLOVETEX POWDER FREE WHITE NITRILE EXAMINATION GLOVES, NON-STERILE
K032011 · LZA
Pt. Wrp Buana Multicorpora
General Hospital · 50d
Cleared Aug 19, 2003
CASHMERE NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES (VIOLET)
K032077 · LZA
Seal Polymer Industries Bhd.
General Hospital · 43d
Cleared Aug 19, 2003
PASCO MIC AND MIC/ID PANELS
K032259 · JWY
Bd Diagnostic Systems
Microbiology · 28d
Cleared Aug 19, 2003
MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE TL
K032335 · JJY
Medical Analysis Systems, Inc.
Chemistry · 21d