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
75409–75432 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 09, 2002
LUMENIS SELECTA DUET
K021550 · GEX
Ellex Medical Pty, Ltd.
General & Plastic Surgery · 88d
Cleared Aug 09, 2002
SYNTHES 2.4 MM CANNULATED COMPRESSION SCREW
K021556 · HWC
Synthes (Usa)
Orthopedic · 88d
Cleared Aug 09, 2002
NATURAL-KNEE II SYSTEM COCR TIBIAL BASEPLATE
K021578 · JWH
Sulzer Orthopedics, Inc.
Orthopedic · 87d
Cleared Aug 09, 2002
MAGLY 4.0 AND 5.5 MM LOCKING SYSTEM
K021579 · HWC
Magly Orthopedics, LLC
Orthopedic · 87d
Cleared Aug 09, 2002
DURACLEAN WITH LYCRA POWDER FREE POLYURETHANE MEDICAL EXAMINATION GLOVE
K022095 · LZA
Wilshire Technologies
General Hospital · 43d
Cleared Aug 09, 2002
GIVEN DIAGNOSTICS SYSTEM
K022362 · NEZ
Given Imaging , Ltd.
Gastroenterology & Urology · 18d
Cleared Aug 08, 2002
URETERAL STENT
K013784 · FAD
Boston Scientific Corp
Gastroenterology & Urology · 267d
Cleared Aug 08, 2002
BOYD DELIVERY UNIT
K020833 · EIA
Boyd Industries, Inc.
Dental · 147d
Cleared Aug 08, 2002
QUANTIM 16 AUTOCLAVE
K021064 · FLE
Scican
General Hospital · 128d
Cleared Aug 08, 2002
OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION
K021143 · LPN
Alcon Universal, Ltd.
Ophthalmic · 121d
Cleared Aug 08, 2002
LIGHTLAS 810 INFRARED LASER PHOTOCOAGULATOR
K021538 · HQF
Lightmed Corp.
Ophthalmic · 90d
Cleared Aug 08, 2002
OSA RIGID INTERNAL FIXATION SYSTEM
K021618 · JEY
Osteomed Corp.
Dental · 84d
Cleared Aug 08, 2002
SHEATH ADAPTER, MODEL SA-09847
K021723 · DYB
Arrow Intl., Inc.
Cardiovascular · 76d
Cleared Aug 08, 2002
ADAPT OPEN ACCESS PORT, MODEL 41233
K021731 · GCJ
Taut, Inc.
General & Plastic Surgery · 76d
Cleared Aug 08, 2002
BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER
K021735 · DQY
Boston Scientific Scimed, Inc.
Cardiovascular · 72d
Cleared Aug 08, 2002
CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000
K022107 · DRN
Cardiomedics, Inc.
Cardiovascular · 41d
Cleared Aug 08, 2002
LAMITRODE S-SERIES (S4 AND S8) LEADS
K022222 · GZB
Advanced Neuromodulation System,Inc
Neurology · 30d
Cleared Aug 08, 2002
AART SILICONE SHEETING
K022223 · MIB
Aesthetic and Reconstructive...
General & Plastic Surgery · 30d
Cleared Aug 08, 2002
MULTIPLE LABELS, POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE
K022305 · LYZ
Heyuan Hongli Industries, Inc.
General Hospital · 23d
Cleared Aug 08, 2002
ACTIBAND
K022404 · ILX
Paw, LLC
Physical Medicine · 16d
Cleared Aug 08, 2002
BD PRESET BLOOD COLLECTION SYRINGE, BD A-LINE BLOOD COLLECTION SYRINGE,...
K022426 · JKA
Becton, Dickinson & CO
Chemistry · 14d
Cleared Aug 07, 2002
ALPHA DRIVE SYSTEM
K013396 · HAW
Alpha Omega , Ltd.
Neurology · 296d
Cleared Aug 07, 2002
ULTIMA SNORING MIKE, MODEL 0540
K020312 · MNR
Braebon Medical Corp.
Anesthesiology · 189d
Cleared Aug 07, 2002
800 SERIES EASYNEB NEBULIZER
K020357 · CAF
Nellcor Puritan Bennett, Inc.
Anesthesiology · 184d