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
42673–42696 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 30, 2012
ACCULIS ACCU21 PMTA MICROWAVE TISSUE ABLATION APPLICATOR
K122762 · NEY
Microsulis Medical Limited
General & Plastic Surgery · 81d
Cleared Nov 30, 2012
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED)
K122893 · LYZ
Geenli Plastic Co, Ltd.
General Hospital · 71d
Cleared Nov 30, 2012
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
K122920 · LYZ
Hebei Leader Plastic Co., Ltd.
General Hospital · 67d
Cleared Nov 30, 2012
POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
K122999 · LZA
Top Glove Sdn. Bhd.
General Hospital · 64d
Cleared Nov 30, 2012
TARGET DETACHABLE COIL
K123377 · HCG
Stryker Neurovascular
Neurology · 29d
Cleared Nov 30, 2012
SOLITAIRE 2 REVASCULARIZATION DEVICE
K123378 · NRY
Micro Therapeutics Dba Ev3 Neurovascular
Neurology · 29d
Cleared Nov 29, 2012
ARROW JUGULAR AXILLO-SUBCLAVIAN CENTRAL CATHETER (JACC)
K121501 · LJS
Arrow International (Subsidiary of...
General Hospital · 192d
Cleared Nov 29, 2012
PLANER BT37 INCUBATOR
K121566 · MQG
Planer Plc
Obstetrics & Gynecology · 184d
Cleared Nov 29, 2012
CONSTRUX MINI PEEK TI SPACER SYSTEM
K121649 · ODP
Orthofix
Orthopedic · 177d
Cleared Nov 29, 2012
TITAN
K121847 · ETY
Interacoustics A/S
Ear, Nose, Throat · 157d
Cleared Nov 29, 2012
MICROSTREAM FILTERLINE ICU
K121927 · CCK
Oridion Medical 1987 , Ltd.
Anesthesiology · 150d
Cleared Nov 29, 2012
TS FIXTURE SYSTEM
K121995 · DZE
Osstem Implant Co., Ltd.
Dental · 143d
Cleared Nov 29, 2012
COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190
K122722 · DFC
Roche Diagnostics
Chemistry · 85d
Cleared Nov 29, 2012
LIGHTSCALPEL
K123037 · GEX
Lightscalpel, LLC
General & Plastic Surgery · 62d
Cleared Nov 29, 2012
CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/ CASSETTE TESTS
K123080 · JXM
Chemtron Biotech, Inc.
Toxicology · 59d
Cleared Nov 29, 2012
PRIMALIF TM LLIF UNITARY PEEK LATERAL LUMBAR INTERBODY FUSION SYSTEM
K123207 · MAX
Osteomed LP
Orthopedic · 48d
Cleared Nov 28, 2012
TXCELL SCANNING LASER DELIVERY SYSTEM
K121475 · GEX
Iridex Corp
General & Plastic Surgery · 194d
Cleared Nov 28, 2012
ENFLOW IV FLUID WARMER, ENFLOW DISPOSABLE CARTRIDGE, ENFLOW CONTROLLER
K121775 · LGZ
Vital Signs, Inc., A GE Healthcare...
General Hospital · 163d
Cleared Nov 28, 2012
MINIFIX BALL MINIFIX ONE
K122052 · DZE
Bonafix Surgical and Dental Implants,...
Dental · 139d
Cleared Nov 28, 2012
SJM CONFIRM
K122161 · MXC
St Jude Medical
Cardiovascular · 131d
Cleared Nov 28, 2012
CHECKMATE SMALL BONE FUSION SYSTEM
K122334 · HRS
Arthrosurface, Inc.
Orthopedic · 118d
Cleared Nov 28, 2012
DIAZYME 25-HYDROXY VITAMIN D EIA KIT DIAZYME 25-HYDROXY VITAMIN D EIA CONTROL...
K122420 · MRG
Diazyme Laboratories
Chemistry · 111d
Cleared Nov 28, 2012
VESSEL ANALYSIS AND AUTOPLAQUE FOR ORS VISUAL
K122429 · LLZ
Object Research Systems (Ors), Inc.
Radiology · 111d
Cleared Nov 28, 2012
PERKINELMER XRD 1622 AP3 MED FLAT PANEL DETECTOR
K122495 · MQB
Perkinelmer, Inc.
Radiology · 104d