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
69673–69696 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 25, 2004
MONITECT MDMA DRUG SCREEN CASSETTE TEST, MODEL MC22
K040203 · DKZ
Branan Medical Corp.
Toxicology · 56d
Cleared Mar 25, 2004
WAKO AUTO KIT PREALBUMIN, WAKO AUTOKIT PREALBUMIN CALIBRATOR SET, PREALBUMIN...
K040226 · JIT
Wako Chemicals USA, Inc.
Chemistry · 52d
Cleared Mar 25, 2004
TENDERWET ACTIVE
K040517 · MGQ
Medline Industries, Inc.
General & Plastic Surgery · 27d
Cleared Mar 25, 2004
POLYETHER URETHANE MATERIAL CHANGE IN NEUROSTIMULATION LEADS
K040568 · GZB
Medtronic Vascular
Neurology · 21d
Cleared Mar 25, 2004
RAPID PROGRAMMER
K040609 · GZB
Advanced Neuromodulation Systems
Neurology · 17d
Cleared Mar 25, 2004
LED TURBO
K040618 · EBZ
Apoza Enterprise Co., Ltd.
Dental · 16d
Cleared Mar 25, 2004
PRECISION LINK DIABETES DATA MANAGEMENT SYSTEM
K040628 · NBW
Abbott Laboratories
Chemistry · 15d
Cleared Mar 25, 2004
MODIFICATION TO TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, TEST STRIPS AND...
K040670 · NBW
Home Diagnostics, Inc.
Chemistry · 10d
Cleared Mar 25, 2004
MODIFICATION TO SAPPHIRE DETACHABLE COIL SYSTEM (TETRIS 3-D)
K040694 · HCG
Micro Therapeutics, Inc.
Neurology · 8d
Cleared Mar 24, 2004
TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIPS, AND...
K032657 · NBW
Home Diagnostics, Inc.
Chemistry · 209d
Cleared Mar 24, 2004
MICRO TARGETING ELECTRODE
K033173 · GZL
FHC, Inc.
Neurology · 175d
Cleared Mar 24, 2004
ENDOBOY
K033644 · GCJ
Geyser S.A.
General & Plastic Surgery · 125d
Cleared Mar 24, 2004
3I PATIENT-SPECIFIC OVERDENTURE BAR
K034035 · NHA
Implant Innovations, Inc.
Dental · 86d
Cleared Mar 24, 2004
INSTATRAK SYSTEM WITH MULTIPLE DATASET NAVIGATION, MODEL IT3500
K040050 · LLZ
Ge Medical Systems Navigation and...
Radiology · 72d
Cleared Mar 24, 2004
MEGVISION, MODEL EQ1000C SERIES
K040051 · OLX
Eagle Technology, Inc.
Neurology · 72d
Cleared Mar 24, 2004
EASY LOOP, MODEL EZL-01
K040110 · EZP
Tools For Surgery, LLC
Gastroenterology & Urology · 64d
Cleared Mar 24, 2004
IFL PROFESSIONAL SYSTEM, MODEL C100
K040156 · GEX
Cyden Limited
General & Plastic Surgery · 61d
Cleared Mar 24, 2004
ACCESS DHEA-S REAGENT ASSAY
K040181 · JKC
Beckman Coulter, Inc.
Chemistry · 57d
Cleared Mar 24, 2004
MICROOPTICAL'S CRITICAL DATA VIEWERS, MODELS MD-3 AND MD-6
K040244 · GCJ
The Microoptical Corporation
General & Plastic Surgery · 50d
Cleared Mar 24, 2004
CALIBRATOR FOR AUTOMATED SYSTEMS PREALBUMIN-ASLO-CERULOPLASMIN (C.F.A.S. PAC)
K040245 · JIX
Roche Diagnostics Corp.
Chemistry · 50d
Cleared Mar 24, 2004
SURGASSIST STRAIGHT LINEAR 4 ROW NO KNIFE DLUS WITH RELOADS
K040398 · GDW
Power Medical Interventions, Inc.
General & Plastic Surgery · 36d
Cleared Mar 24, 2004
MODIFICATION TO AMS LARGE PORE POLYPROPYLENE MESH
K040521 · OTP
American Medical Systems, Inc.
Obstetrics & Gynecology · 23d
Cleared Mar 24, 2004
CARDIOMD-AC
K040616 · KPS
Danish Diagnostic Development A/S
Radiology · 15d
Cleared Mar 23, 2004
SIEMENS KION ANESTHESIA WORKSTATION - EXTENDED MODES FUNCTIONALITY, MODELS:...
K024213 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 459d